{"id":7489,"date":"2020-04-30T12:27:13","date_gmt":"2020-04-30T12:27:13","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7489"},"modified":"2021-09-30T05:09:53","modified_gmt":"2021-09-30T05:09:53","slug":"top-fda-regulatory-pathways-for-medical-devices-based-on-classification","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/","title":{"rendered":"Top FDA Regulatory Pathways for Medical Devices Based on Classification"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1ce0769a31\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1ce0769a31\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_pathway_for_Class_I_Medical_Devices\" title=\"Regulatory pathway for Class I Medical Devices\">Regulatory pathway for Class I Medical Devices<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#The_surgical_scalpel\" title=\"The surgical scalpel\">The surgical scalpel<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#FDA_Regulatory_Pathways_for_Medical_Devices_Risk_Classes\" title=\"FDA Regulatory Pathways for Medical Devices: Risk Classes\">FDA Regulatory Pathways for Medical Devices: Risk Classes<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Has_the_classification_already_been_defined\" title=\"Has the classification already been defined? \">Has the classification already been defined? <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Narrowing_down_the_specific_device_classification\" title=\"Narrowing down the specific device classification\">Narrowing down the specific device classification<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_Pathway_for_Class_II_Medical_Devices\" title=\"Regulatory Pathway for Class II Medical Devices\">Regulatory Pathway for Class II Medical Devices<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#FDA_510K_submission_Pre-market_submission\" title=\"FDA 510(K) submission: Pre-market submission\">FDA 510(K) submission: Pre-market submission<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Q-submission_process\" title=\"Q-submission process\">Q-submission process<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_pathway_for_Class_III_medical_devices\" title=\"Regulatory pathway for Class III medical devices\">Regulatory pathway for Class III medical devices<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Pre-market_Approval\" title=\"Pre-market Approval \">Pre-market Approval <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Class_III_Medical_Device_Regulatory_Pathway_Example\" title=\"Class III Medical Device Regulatory Pathway: Example\">Class III Medical Device Regulatory Pathway: Example<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Investigational_Device_Exemption_IDE_pathway\" title=\"Investigational Device Exemption (IDE) pathway\">Investigational Device Exemption (IDE) pathway<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#De-Novo_request\" title=\"De-Novo request\">De-Novo request<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Breakthrough_Devices_Program\" title=\"Breakthrough Devices Program\">Breakthrough Devices Program<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Emergency_Use_Authorizations\" title=\"Emergency Use Authorizations \">Emergency Use Authorizations <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Humanitarian_Device_Exemption\" title=\"Humanitarian Device Exemption \">Humanitarian Device Exemption <\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/adam-freeman?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">Adam Freeman<\/a>, ex-FDA investigator for medical devices, describes the FDA regulatory pathways for medical devices, based on classification and intended use.\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">The regulatory pathway of a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">medical device<\/a> depends mostly on its labeling.\u00a0 We can ask a philosophical question in an effort to tease out that pathway for which a device takes in becoming a medical device.\u00a0 <\/span><\/p>\n<blockquote><p><strong>What separates an unregulated knife from an FDA regulated surgical scalpel?\u00a0 The indications for use.\u00a0 <\/strong><b>The indications you intend to market your product under will establish the framework of applicable regulations<\/b><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_pathway_for_Class_I_Medical_Devices\"><\/span>Regulatory pathway for Class I Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h6><span class=\"ez-toc-section\" id=\"The_surgical_scalpel\"><\/span>The surgical scalpel<span class=\"ez-toc-section-end\"><\/span><\/h6>\n<p><span style=\"font-weight: 400;\">Let\u2019s explore how we progress through this thought experiment to arrive at the regulated surgical scalpel and its corresponding regulatory requirements.\u00a0 Then let\u2019s explore those alternative pathways existing for other classes of devices and breakthrough technologies.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The knife evolves into the surgical scalpel by first establishing indications for use.\u00a0 An autoclavable blade for use in surgical procedures by a qualified professional, for example.\u00a0 The Federal Food, Drug, and Cosmetic Actdefines a regulated device in part in section 201(h).\u00a0 That section reads in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe term \u2018\u2018<\/span><b><i>device<\/i><\/b><span style=\"font-weight: 400;\">\u2019\u2019 *** means an <\/span><b>instrument<\/b><span style=\"font-weight: 400;\">, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including <\/span><i><span style=\"font-weight: 400;\">any component, part, or accessory<\/span><\/i><span style=\"font-weight: 400;\">, which is ***<\/span><b>intended for use<\/b><span style=\"font-weight: 400;\"> in the diagnosis of disease or other conditions, or <\/span><b>in the<\/b><b>cure<\/b><span style=\"font-weight: 400;\">, <\/span><b>mitigation<\/b><span style=\"font-weight: 400;\">, <\/span><b>treatment<\/b><span style=\"font-weight: 400;\">, or <\/span><b>prevention of disease<\/b><span style=\"font-weight: 400;\">, <\/span><b>in man or other animals<\/b><span style=\"font-weight: 400;\">, or ***<\/span><b>intended to affect the structure or any function of the body of man or other animals<\/b><span style=\"font-weight: 400;\">, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes\u201d.<\/span><b>[1]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Once we have identified the intent for which our device is intended to be used, we can perform a search to determine the classification of the device. When there is no defined classification for the device, we will explore those pathways too.\u00a0 Contained within Title 21 of the United States Code of Federal Regulations is part 860.\u00a0 This part defines the Medical Device Classification Procedures. These classification procedures are prescribed by FDA for device developers to follow to define the risks class in which their product is categorized under.\u00a0 <\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_Regulatory_Pathways_for_Medical_Devices_Risk_Classes\"><\/span>FDA Regulatory Pathways for Medical Devices: Risk Classes<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Classes are broken into three risk classes based on FDA\u2019s own risk benefit analysis.\u00a0 These classes are defined as follows:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><b>Class I<\/b><span style=\"font-weight: 400;\"> means the <\/span><b>class of devices that are subject to only the general controls<\/b><span style=\"font-weight: 400;\"> authorized by or <\/span><b>under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device<\/span><\/i><span style=\"font-weight: 400;\">, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury. ***<\/span><\/p>\n<p><b>Class II<\/b><span style=\"font-weight: 400;\"> means the <\/span><b>class of devices that is or eventually will be subject to special controls<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, post-market surveillance, patient registries, development and disseminationof guidance documents <\/span><\/i><span style=\"font-weight: 400;\">(including guidance on the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. <\/span><i><span style=\"font-weight: 400;\">For a device that is purported or represented to be for use in supporting or sustaining human life<\/span><\/i><span style=\"font-weight: 400;\">, <\/span><i><span style=\"font-weight: 400;\">the Commissioner shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance<\/span><\/i><span style=\"font-weight: 400;\">. ***<\/span><\/p>\n<p><b>Class III<\/b><span style=\"font-weight: 400;\"> means the <\/span><b>class of devices for which premarket approval is or will be required in accordance with section 515 of the act<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness<\/span><\/i><span style=\"font-weight: 400;\"> or that application of special controls described in paragraph (c)(2) of this section would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.\u201d<\/span><b>[2]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Has_the_classification_already_been_defined\"><\/span><span style=\"font-weight: 400;\"><strong>Has the classification already been defined?<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">By searching within part 862 to 892 of Title 21 of the United States Code of Federal Regulations, one can determine if a classification has been already defined for their product.<br \/>\n21 CFR section 860.1(b) reads in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><b>This part prescribes the criteria and procedures to be used<\/b><span style=\"font-weight: 400;\"> by classification panels in making their recommendations and by the Commissioner <\/span><b>in making<\/b><span style=\"font-weight: 400;\"> the Commissioner\u2019s <\/span><b>determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices.<\/b><span style=\"font-weight: 400;\"> Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), <\/span><b>this part also provides procedures for manufacturers, importers, and other interested persons to participate in proceedings to classify and reclassify devices<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">This part also describes the kind of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to classification panels or to the Commissioner in connection with classification and reclassification proceedings will be available to the public<\/span><\/i><span style=\"font-weight: 400;\">\u201d.<\/span><b>[2]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Classifications for devices are defined within 21 CFR in the following parts:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 862 \u2013 Clinical Chemistry and Clinical Toxicology Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 864 \u2013 Hematology and Pathology Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 866 \u2013 Immunology and Microbiology Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 868 \u2013 Anesthesiology Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 870 \u2013 Cardiovascular Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 872 \u2013 Dental Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 874 \u2013 Ear, Nose, and Throat Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 876 \u2013 Gastroenterology \u2013 Urology Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 878 \u2013 General and Plastic Surgery Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 880 \u2013 General Hospital and Personal Use Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 882 \u2013 Neurological Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 884 \u2013 Obstetrical and Gynecological Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 886 \u2013 Ophthalmic Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 888 \u2013 Orthopedic Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 890 \u2013 Physical Medicine Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 892 \u2013 Radiology Devices<\/span><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Narrowing_down_the_specific_device_classification\"><\/span><strong>Narrowing down the specific device classification<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">For the intentions of defining our surgical scalpel, we will turn our attention to Part 878 \u2013 General and Plastic Surgery Devices.\u00a0 Within this part, we find under section 878.4800 the appropriate classification for our surgical scalpel.\u00a0 This section reads in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><b>Manual surgical instrument for general use.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">(a) Identification. <\/span><i><span style=\"font-weight: 400;\">A manual surgical instrumentfor general use is a non-powered, hand-held, or hand-manipulated device<\/span><\/i><span style=\"font-weight: 400;\">, either <\/span><i><span style=\"font-weight: 400;\">reusable<\/span><\/i><span style=\"font-weight: 400;\"> or disposable, <\/span><i><span style=\"font-weight: 400;\">intended to be used in various general surgical procedures<\/span><\/i><span style=\"font-weight: 400;\">. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, <\/span><i><span style=\"font-weight: 400;\">cutter<\/span><\/i><span style=\"font-weight: 400;\">, <\/span><i><span style=\"font-weight: 400;\">dissector<\/span><\/i><span style=\"font-weight: 400;\">, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, <\/span><b><i>knife<\/i><\/b><span style=\"font-weight: 400;\">, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, <\/span><b><i>scalpel blade<\/i><\/b><span style=\"font-weight: 400;\">, <\/span><b><i>scalpel handle<\/i><\/b><span style=\"font-weight: 400;\">, <\/span><b><i>one-piece scalpel<\/i><\/b><span style=\"font-weight: 400;\">, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(b) <\/span><b>Classification<\/b><span style=\"font-weight: 400;\">. <\/span><i><\/i>Class I (general controls)<span style=\"font-weight: 400;\">.<br \/>\n<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in \u00a7878.9.\u201d <\/span><b>[2]<\/b><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">Within this definition for a manual surgical instrument for general use, we find our surgical scalpel is classified as a Class I medical device.\u00a0 <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\"><strong>This translates to this device requiring establishment of those general control requirements prescribed by FDA.\u00a0<\/strong> Those general control requirements are defined within the United States Federal Food Drug and Cosmetic Act, and are listed as follows:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 501 (adulteration)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 502 (misbranding)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 510 (registration)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 516 (banned devices)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 518 (notification and other remedies)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 519 (records and reports)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Section 520 (general provisions)<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_Pathway_for_Class_II_Medical_Devices\"><\/span><strong>Regulatory Pathway for Class II Medical Devices<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Let\u2019s consider other devices and their prescribed requirements by classification.\u00a0 If we bump up our risk category by adding power to our cutting device, we arrive at a Class II medical device. 21 CFR Section 878.4400 reads in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><b>Electrosurgical cutting and coagulation device and accessories.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(b) Classification. <\/span><span style=\"font-weight: 400;\">Class II\u201d.<\/span><b>[2]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Now, since we have bumped up our risk class to a Class II regulated medical device, our product requires clearance from FDA through their pre-market submission process.\u00a0 That process is required before the product is cleared for marketing and sale in the United States. \u00a0 <strong>Also, as a Class II device, our requirements evolve from general controls to those controls prescribed by current Good Manufacturing Practice requirements for manufacturing medical devices.\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">These requirements translate to establishment of a Quality Management System which steers and manages the design, manufacturing processes, and overall quality and compliance to those requirements prescribed by FDA and harmonized standards.\u00a0 I have found a useful listing of those requirements buried in one of FDA\u2019s compliance guidance program manuals.\u00a0 FDA\u2019s CPGM 7382.845, Inspection of Medical Device Manufacturers <\/span><b>[3]<\/b><span style=\"font-weight: 400;\">, list those requirements as they are defined within Title 21 of the United States Code of Federal Regulations <\/span><b>[2]<\/b><span style=\"font-weight: 400;\">. Those requirements are as follows:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 7, Subpart C, Recalls<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 11, Electronic Records and Electronic Signatures<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Parts 16 and 17, Hearing Procedures<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 800, Subpart C, Administrative Detention<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 803, Medical Device Reporting<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 806, Reports of Corrections and Removals<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 807, Establishment Registration and Device Listing<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 809.10, Labeling For In Vitro Diagnostic Devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 810, Medical Device Recall Authority<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 820, Current Good Manufacturing Practices\/Quality System Regulation<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 821, Tracking Requirements<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Parts 1000\u20131050, Radiation Regulations and Standards<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Every Class II or Class III product shall meet these listed requirements which are pertinent to their device (Tracking Requirements and Radiation Regulations are device specific).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Continuing down our path of the development of a Class II product, we revisit the pre-market submission process. <\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"FDA_510K_submission_Pre-market_submission\"><\/span><strong>FDA 510(K) submission: Pre-market submission<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This process can be summarized in part by this quote borrowed from FDA\u2019s website.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><span style=\"font-weight: 400;\">A <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k)<\/a> is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device *** Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.\u201d<\/span><b>[4]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">As FDA promotes transparency in their processes, they have published many useful guidances for the submission process of 510(k)s.\u00a0 I recommend their guidance titled in part, \u201cThe 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff\u201d<\/span><b>[5]<\/b><span style=\"font-weight: 400;\">.\u00a0 This document identifies what information is requested for submitting a premarket submission to FDA. Hiring a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">510(k) submissions expert<\/a> can help you ensure the document is prepared as per the guidelines.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\"><strong>Also read: Top 13 mistakes to avoid in a 510(k) submission for quick FDA clearance<\/strong><\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Q-submission_process\"><\/span><strong>Q-submission process<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">When there is uncertainty whether a device can be perceived as substantially equivalent or a new device,a new device translating to the technology is novel or an existing device which is desired to be used for a new indication for use, FDA offers a mechanism for those exploring locking down their device classification and risk class.\u00a0<strong> This is a best practice, in my opinion, before proceeding down the development pathway.\u00a0 The mechanism is called the Q-Submission process.<\/strong>\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">In FDA\u2019s guidance titled in part, \u201cRequests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff\u201d, FDA writes in part:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cthis guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">Research<\/a> (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products\u201d.<\/span><b>[6]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Whether your organization intends to bring a new device, Class II device, or Class III device to market, FDA is open to assisting you with this process if your organization is determined enough and patient enough to follow FDA\u2019s prescribed pathways.\u00a0 Those \u201cpre-\u201c submission meetings can be invaluable in defining those baseline decisions regarding the device classification, regulatory framework, and pathway the developer shall follow based on that classification.\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Since we have discussed those pathways now for Class I and Class II products, let\u2019s dive deeper into those other pathways for device approval.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_pathway_for_Class_III_medical_devices\"><\/span><span style=\"font-weight: 400;\"><strong>Regulatory pathway for Class III medical devices<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Class III medical devices are grouped in this category because they are the perceived to be in the highest risk class for medical devices.\u00a0 FDA writes in part on their website,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cClass III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&amp;C Act in order to obtain marketing approval.\u201d <\/span><b>[7]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">As with many FDA processes, FDA has published a plethora of guidances to support the pathway for clearing Class III medical devices.<\/span><\/p>\n<p>The two foundational documents I recommend for following the development pathway for a Class III device are:<\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 <\/span> <span style=\"font-weight: 400;\">Acceptance and Filing Reviews for &#8220;You remind me of everything that followed. Every day since then has been a gift.&#8221; Guidance for Industry and Food and Drug Administration Staff.<\/span><b>[8]<\/b><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 <\/span> <span style=\"font-weight: 400;\">Guidance for Industry and FDA Staff Premarket Approval Application Modular Review. <\/span><b>[9]<\/b><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Pre-market_Approval\"><\/span><strong>Pre-market Approval <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Much like a pre-market submission, a pre-market approval application requires modules of data be submitted to FDA for review and approval before those products are cleared for use.\u00a0 FDA appreciates being engaged with the developer during the development pathway so they can evaluate testing protocols before and after they are implemented. Frequently, with high risk devices, development activities for those devices already require engagement with FDA in order to deploy design validation testing (testing in humans).\u00a0 The mechanism for performing this testing is through the Investigational Device Exemption (IDE) process.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Class_III_Medical_Device_Regulatory_Pathway_Example\"><\/span><strong>Class III Medical Device Regulatory Pathway: Example<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">For an example of a device being developed down the Class III pathway, including the IDE study, let\u2019s consider a<strong> cardiovascular device<\/strong>.\u00a0 These are frequently Class III because they are usually life sustaining or high risks devices.\u00a0 For this example, lets consider a ventricular assists \/ bypass device.\u00a0 A ventricular bypass (assist) device is defined in section 21 CFR 870.3545.\u00a0 That definition reads in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cA ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body. ***<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Classification. <\/span><span style=\"font-weight: 400;\">Class III (premarket approval).\u201d <\/span><b>[2]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Investigational_Device_Exemption_IDE_pathway\"><\/span><strong>Investigational Device Exemption (IDE) pathway<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The Investigational Device Exemption (IDE) pathway is for high risks products requiring permission for use in controlled studies to collect clinical data for design validation.\u00a0 FDA has provided this pathway to enable prototypes be used for evaluation to demonstrate safety and efficacy.\u00a0 Special requirements have been defined for proceeding down the IDE pathway.\u00a0 Those requirements are listed below:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 812, Investigational Device Exemptions<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 50, Protection of Human Subjects<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 56, Institutional Review Boards<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 54, Financial Disclosure by Clinical Investigators<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 820 Subpart C, Design Controls of the Quality System Regulation<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The design validation, IE clinical trial, of this ventricular bypass (assist) device is a candidate to use this IDE development pathway as a milestones toward obtaining pre-market approval as a Class III FDA cleared medical device.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If a developer believes that their device is unclassified, is a novel technology, or a novel indication for use, the pathway for development may be through one of FDA\u2019s alternative pathways.\u00a0 Those alternatives include the Humanitarian Device Exemption (HDE) exemption pathway, the De Novo requests pathway, and FDA\u2019s breakthrough and emergency pathways.Let\u2019s break these pathways apart individually and dissect how they work based on their intent.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A footnote in FDA\u2019s guidance, Medical Device Classification Product Codes Guidance for Industry and Food and Drug Administration Staff,reports in part,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cAn unclassified device is a pre-amendments device for which a classification regulation has not been promulgated.\u00a0 Unclassified devices require submission of a 510(k)premarket notification to CDRH. A not-classified device is a post-amendments device for which the Agency has not yet reviewed a marketing application or for which theAgency has not made a final decision on such a marketing application\u201d.<\/span><b>[10]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"De-Novo_request\"><\/span><strong>De-Novo request<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Although FDA recommends an unclassified device to be submitted through their 510(k) process, I recommend the developer follow the Q-Submission pathway first to get concurrence from FDA regarding the risk class for their device. An alternative to this pathway is a De Novo request.\u00a0 A De Novo request is explained in part on FDA\u2019s website as follows,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201ca pathway to classify novel medical devices for which <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/regulatory-controls\/general-controls-medical-devices\"><span style=\"font-weight: 400;\">general controls<\/span><\/a><span style=\"font-weight: 400;\"> alone, or general and <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/regulatory-controls\"><span style=\"font-weight: 400;\">special controls<\/span><\/a><span style=\"font-weight: 400;\">, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legallymarketed <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/how-find-and-effectively-use-predicate-devices\"><span style=\"font-weight: 400;\">predicate device<\/span><\/a><span style=\"font-weight: 400;\">. De Novo classification is a risk-based classification process.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\"><span style=\"font-weight: 400;\">510(k)<\/span><\/a><span style=\"font-weight: 400;\">] submissions.\u201d<\/span><b>[11]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">A De Novo request is similar to a Q-Submission in that both are seeking concurrence from FDA regarding the risk classification of the product. \u00a0 That risk classification is essential to define, in order to proceed with the design and development pathway in implementing those pertinent requirements, controls, and studies.\u00a0 A new device indicated for the treatment of Covid-19 could be considered for development through the De Novo request pathway as the technology is still considered novel. However, as those kinds of technologies are not only novel, they are needed under an emergency situation making other pathways opportunities for expedited deployment.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Breakthrough_Devices_Program\"><\/span><strong>Breakthrough Devices Program<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<blockquote><p><strong>Covid-19 and Medical Device Innovation<br \/>\n<\/strong><span style=\"font-weight: 400;\">With the challenges encountered due to Covid-19, breakthrough pathways and Emergency Use Authorization pathways have become hot topics for emerging technologies intended to help fight the outbreak.\u00a0 Although these pathways have existed for a long time, their popularity as a pathway for bringing new technologies to market has been noticeably increasing with the crisis.\u00a0 <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">Let\u2019s break down each of those pathways individually to understand better how they work.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA reports on their website,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency&#8217;s mission to protect and promote public health\u201d.<\/span><b>[12]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">In order for a product to be eligible for the Breakthrough Devices Program the device must demonstrate greater effectiveness over current treatment or diagnosis technologies available in treatment of life-threatening or irreversibly debilitating human diseases or conditions.\u00a0 Additionally, that product must meet at least one of the following requirements:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Represents Breakthrough Technology<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u201cFDA considers whether the device represents a novel technology or novel application of an existing technology that has the potential to lead to a clinical improvement in the diagnosis, treatment (including monitoring of treatment), cure, mitigation, or prevention of the life-threatening or irreversibly debilitating disease or condition\u201d. <\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">No Approved or Cleared Alternatives Exist<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u201cFDA considers whether there is a drug, biological product, device, or combination product that has received FDA marketing authorization after premarket review for the same indication(s) being considered (i.e., whether there is an alternative product that FDA has approved, cleared, or licensed, or for which FDA has granted a De Novo request)\u201d.<\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Offers Significant Advantages over Existing Approved or Cleared Alternatives,<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u201cFDA considers the potential, compared to existing approved or cleared alternatives, \u201cto reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients\u2019 ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies.\u201d\u201d<\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Device Availability is in the Best Interest of Patients<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u201cFDA considers whether the proposed device and indications for use provide another type of specific public health benefit\u201d.<\/span><b>[13]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">In addition to this guidance referenced above, FDA has published a variety of development guidances and tools intended to assists companies with providing FDA with the data they need in an expedited manner.\u00a0 This is also the case for technologies pushed through Emergency Use Authorizations.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Emergency_Use_Authorizations\"><\/span><span style=\"font-weight: 400;\"><strong>Emergency Use Authorizations<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Emergency Use Authorizations (EAUs)may be initiated by FDA if they determine there is an emergency need which is unfulfilled.\u00a0 In order to obtain an EUA for your product, FDA expects your organization to set up a pre-EUA meeting.\u00a0 Templates exists on FDA\u2019s website for the information they are seeking to initiate the EUA pathway.\u00a0 Once the Pre-EUA meeting has kicked off, FDA will provide guidance on how they want to collaborate with your organization to proceed with development and release of your product.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Humanitarian_Device_Exemption\"><\/span><span style=\"font-weight: 400;\"><strong>Humanitarian Device Exemption<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Humanitarian Device Exemption and Humanitarian Use Devices are pathways for consideration for devices which are intended to be used on a small patient population.\u00a0 FDA defines a Humanitarian Use Device (HUD) in part as<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201ca medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year\u201d. <\/span><b>[14]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">HDEs allow exemption from the requirements to demonstrate effectiveness of the device in accordance those requirements prescribed within sections 514 and 515 of the Food Drug and Cosmetic Act.Sticking with our cardiovascular examples, HDEs have been issued by FDA for pediatric ventricular assist devices because those patient populations meet FDA\u2019s criteria to constitute that condition being eligible under their HDE pathway (IE. that disease or condition affects or is manifested in not more than 8,000 individuals in the United States per year).<\/span><\/p>\n<blockquote><p>Although FDA has the intention of being transparent within those processes they offer to the public, those processes at times can be cryptic and daunting.\u00a0 I was an Investigator for the Food and Drug Administration seven and a half years before taking the leap into consulting.\u00a0 During my time as a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">regulatory consultan<\/a>t I\u2019ve assisted with these FDA regulatory pathways for medical devices. The leap from regulating to coaching on design, manufacturing, and compliance has been refreshing.\u00a0 Its also enabled me the opportunity to take on innovative and entrepreneurial projects which is something I am passionate about.<\/p><\/blockquote>\n<p><strong>Need help to figure out the best FDA pathway for your medical device? <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/adam-freeman?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">Consult Adam Freeman for regulatory support. <\/a><\/strong><\/p>\n<p><strong>OR View other <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">FDA submission experts<\/a> on Kolabtree.<br \/>\n<\/strong><\/p>\n<hr \/>\n<p><b>References<\/b><span style=\"font-weight: 400;\">:<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">Federal Food, Drug, and Cosmetic Act:<\/span><a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2014-title21\/pdf\/USCODE-2014-title21.pdf\"> <span style=\"font-weight: 400;\">https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2014-title21\/pdf\/USCODE-2014-title21.pdf<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Title 21 of the United States Code of Federal Regulations:<\/span><a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/CFR-2011-title21-vol8\/pdf\/CFR-2011-title21-vol8-chapI-subchapH.pdf\"> <span style=\"font-weight: 400;\">https:\/\/www.govinfo.gov\/content\/pkg\/CFR-2011-title21-vol8\/pdf\/CFR-2011-title21-vol8-chapI-subchapH.pdf<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s CPGM 7382.845, Inspection of Medical Device Manufacturers:<\/span><a href=\"https:\/\/www.fda.gov\/media\/80195\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/80195\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s Premarket Notification Website:<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff:<\/span><a href=\"https:\/\/www.fda.gov\/media\/82395\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/82395\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff:<\/span><a href=\"https:\/\/www.fda.gov\/media\/114034\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/114034\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s Premarket Approval (PMA) Website:<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-approval-pma\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-approval-pma<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance for Industry and Food and Drug Administration Staff:<\/span><a href=\"https:\/\/www.fda.gov\/media\/83408\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/83408\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Guidance for Industry and FDA Staff Premarket Approval Application Modular Review:<\/span><a href=\"https:\/\/www.fda.gov\/media\/73513\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/73513\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Medical Device Classification Product Codes Guidance for Industry and Food and Drug Administration Staff<\/span><span style=\"font-weight: 400;\">:<\/span><a href=\"https:\/\/www.fda.gov\/media\/82781\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/82781\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s De Novo Classification Request Website:<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/de-novo-classification-request\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/de-novo-classification-request<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s Breakthrough Devices Program:<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s Guidance Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff<\/span><span style=\"font-weight: 400;\">:<\/span><a href=\"https:\/\/www.fda.gov\/media\/108135\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/108135\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u2019s Humanitarian Use Device (HUD) Designation Program:<\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/industry\/developing-products-rare-diseases-conditions\/humanitarian-use-device-hud-designation-program\">https:\/\/www.fda.gov\/industry\/developing-products-rare-diseases-conditions\/humanitarian-use-device-hud-designation-program<\/a><\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adam Freeman, ex-FDA investigator for medical devices, describes the FDA regulatory pathways for medical devices, based on classification and intended use.\u00a0 The regulatory pathway of a medical device depends mostly on its labeling.\u00a0 We can ask a philosophical question in an effort to tease out that pathway for which a device takes in becoming a<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":7505,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[528,559,524],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Top FDA Regulatory Pathways for Medical Devices Based on Classification<\/title>\n<meta name=\"description\" content=\"Ex-FDA investigator Adam Freeman recommends top FDA regulatory pathways for medical devices including 510(k), De Novo, IDE, Breakthrough Devices, and more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Top FDA Regulatory Pathways for Medical Devices Based on Classification\" \/>\n<meta property=\"og:description\" content=\"Ex-FDA investigator Adam Freeman recommends top FDA regulatory pathways for medical devices including 510(k), De Novo, IDE, Breakthrough Devices, and more.\" \/>\n<meta property=\"og:url\" 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