{"id":8126,"date":"2020-07-28T10:59:55","date_gmt":"2020-07-28T10:59:55","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8126"},"modified":"2020-07-28T11:08:36","modified_gmt":"2020-07-28T11:08:36","slug":"a-guide-to-fda-design-controls-for-your-medical-device","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/","title":{"rendered":"A guide to FDA Design Controls for your medical device"},"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-69f1dd7c68995\" 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-69f1dd7c68995\"><\/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\/a-guide-to-fda-design-controls-for-your-medical-device\/#Applicability\" title=\"Applicability\u00a0\">Applicability\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Device_Design_Phases\" title=\"Device Design Phases\">Device Design Phases<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#D_D_Planning_Phase\" title=\"D&amp;D Planning Phase\">D&amp;D Planning Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Input_Phase\" title=\"Design Input Phase\">Design Input Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Output_Phase\" title=\"Design Output Phase\">Design Output Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Review_Phase\" title=\"Design Review Phase\">Design Review Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Verification_Phase\" title=\"Design Verification Phase\">Design Verification Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Validation_Phase\" title=\"Design Validation Phase\">Design Validation Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Transfer_Phase\" title=\"Design Transfer Phase\">Design Transfer Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Changes_Phase\" title=\"Design Changes Phase\">Design Changes Phase<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_History_File_DHF\" title=\"Design History File (DHF)\u00a0\">Design History File (DHF)\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Shreya Chenni, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDADesignControl\">freelance regulatory writer<\/a> for medical devices, provides a 10-minute guide to FDA design controls for your medical device.\u00a0\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">One of the major causes of medical device recalls is the lack of design control as identified by the FDA [3,3a]. The pre-production controls were then added to the device GMP regulations. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Applicability\"><\/span><b>Applicability\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">All Class II, III and the following Class I devices are subjected to design controls:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Devices automated with computer software<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">868.6810 Catheter, Tracheobronchial Suction\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">878.4460 Glove, Surgeon\u2019s\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">880.6760 Restraint, Protective\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">892.5650 System, Applicator, Radionuclide, Manual\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">892.5740 Source, Radionuclide Teletherapy<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Devices automated with computer software<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tracheobronchial suction catheters<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Surgeon&#8217;s gloves<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Protective restraints<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">System, radionuclide, applicator, manual<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Source, radionuclide teletherapy<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Design controls apply to all D&amp;D activities \u2013 for novel or improved devices being developed in the pre-market phase, as well as for changes to existing, marketed devices. Design controls do not apply to <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> activities conducted during the proof of concept stage.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Design controls can be applied to any product development process. The following flowcharts are examples of the design controls applied to a traditional Waterfall design process and V-model process for Software (SW).<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8136 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1.png\" alt=\"\" width=\"1316\" height=\"940\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1.png 1316w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-300x214.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-1024x731.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-768x549.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-1080x771.png 1080w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-269x192.png 269w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-300x214@2x.png 600w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-269x192@2x.png 538w\" sizes=\"(max-width: 1316px) 100vw, 1316px\" \/><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/116573\/download\"><i><span style=\"font-weight: 400;\">Source: Design Control Guidance for Medical Device Manufacturers, CDRH-FDA<\/span><\/i><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Device_Design_Phases\"><\/span><b>Device Design Phases<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"D_D_Planning_Phase\"><\/span><b>D&amp;D Planning Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">D&amp;D plans should be established and maintained. The plan shall describe or reference the design and development activities and assign responsibilities for implementation. At a minimum the FDA recommends on including the following in the plan:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Goals and objectives of the D&amp;D program<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Delineation of responsibilities of the design activities<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identify major tasks, deliverables and assign responsibility for each task<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Scheduling of major task in accordance with the main development timeframe<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identify the major reviews and decision points\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identify reviewers, reviewing team and the procedures to be followed by reviewers<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Controls of design documentation<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Notification activities<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The plan should be reviewed, updated, and approved as design and development evolves.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Input_Phase\"><\/span><b>Design Input Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This is the starting point for product design. The medical device is designed and developed to meet the user requirements. Gather the user requirements from various sources such as\u00a0 customer surveys, feedback from the physicians, complaints. These requirements are transferred into design inputs.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Design inputs:<\/span> <span style=\"font-weight: 400;\">These are the physical and performance requirements of a device that are used for device design. The design input phase consists of the converting user requirements into product requirements. Regulatory requirements are considered when defining design inputs. Design input requirements must be comprehensive, unambiguous and verifiable objectively. The inputs requirements can be put together into 3 categories:\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Functional requirements, that describe what the device does. For example: <\/span><i><span style=\"font-weight: 400;\">The wheelchair shall move forward when indicated by the user<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Performance requirements, which will specify how much and how well the device should perform. For example: <\/span><i><span style=\"font-weight: 400;\">The wheelchair shall move with a speed of 2m\/s in the forward direction<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Interface requirements, specify characteristics of the device which are critical to compatibility with external systems, such as user\/patient interface. For example: <\/span><i><span style=\"font-weight: 400;\">The wheelchair shall have buttons with direction indicating symbols<\/span><\/i><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Here is an example, which defines user needs and converts it to design input:\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">User need<br \/>\n<\/span>Device should be portable and bluetooth enabled<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Design input\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">Identify the applicable FDA recognised or an international standard to be compliant with. Such as:<\/span><\/i><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">AAMI TIR 69: Association for the Advancement of Medical Instrumentation &#8211; Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems (2017)\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IEC 60601-1-2 Edition 3: 2007: Medical Electrical Equipment &#8211; Part 1-2: General Requirements for Safety &#8211; Collateral Standard: Electromagnetic Compatibility &#8211; Requirements and Tests<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">UL 2054 &#8211; Standard for Household and Commercial Batteries<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">List the performance and other specific inputs. Such as:\u00a0<\/span><\/i><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The device shall be DC powered<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bluetooth module shall be used\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Weight: approx 6lbs or 6lbs+\/- 2lbs (<\/span><i><span style=\"font-weight: 400;\">Inputs should have quantitative limits to ensure verification)<\/span><\/i><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Design_Output_Phase\"><\/span><b>Design Output Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Design outputs are the results of a design effort at each design phase and at the end of the total design effort. Examples of design outputs are engineering drawings, labeling, work instructions and other product specifications. Other design outputs include results of risk analysis, results of verification activities, biocompatibility test results and software source code.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Design outputs should not be released before review and approval by the responsible personnel. It should also be noted that any changes to the device after the approval of design outputs\/inputs will be controlled through review and approval by concerned personnel.\u00a0 A design review is required at the end of this phase.<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Review_Phase\"><\/span><b>Design Review Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">A design review should be held after the design output phase. The design reviews should follow established procedures and be documented in the Design History File (DHF). The participants of each design review should have representatives from all functional groups.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Formal reviews are recommended to be conducted at the end of important project milestones. Commonly, design reviews are conducted after the design output phase, V&amp;V phase and design transfer phanse. This also depends on the complexity of the device development. FDA requires at least one design review.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Verification_Phase\"><\/span><b>Design Verification Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Design verification is confirmation by objective evidence that design output meets design input. <\/span><b>Basically, it is Design Input = Design Output. <\/b><span style=\"font-weight: 400;\">The verification activities should be performed per the established procedures. Examples of verification include EMC and electrical testing, visual inspection, non-clinical testing activities, fault tree analysis of process or design and failure modes and effects analysis. Verification ensures that the product specification technical requirements are met. All the verification activities have to be documented.\u00a0<\/span><\/p>\n<p><b>Traceability Matrix:<\/b><span style=\"font-weight: 400;\"> This document consists of design inputs and outputs listed in a tabular format. For each input the corresponding output is referenced. This method of verification is used when\u00a0 inputs and outputs are both documents.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Validation_Phase\"><\/span><b>Design Validation Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Design Validation means establishing by objective evidence that specifications (specified requirements) conform with user needs and intended use(s).\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Validation is typically <\/span><b>conducted under actual or simulated conditions<\/b><span style=\"font-weight: 400;\">. Examples of validation include clinical trials, clinical evaluation, human factors tests, address packaging and labeling, analysis and inspections. Results of validation activities and\/or validation reports should be documented which will be part of the Design History File (DHF).\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Transfer_Phase\"><\/span><b>Design Transfer Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">After the completion of V&amp;V stage, the design transfer takes place. This includes the transfer of device design into product specifications ensuring device quality. This phase is very critical because once the production of the device begins it will be subjected to design change control and can result in financial loss if problems are encountered. Design transfer should take place per the established procedure. Also, it should be ensured that documents that include product specifications are reviewed and approved before initiating design transfer.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Changes_Phase\"><\/span><b>Design Changes Phase<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Design change control begins with design transfer and continues throughout the lifecycle. Any design change after design transfer will result in an Engineering Change Notice (ECN) to be carried out per an established procedure. It should be ensured that with any design change, related documents such as risk management report, instructions for use, verification and validation reports must be re-visited and updated as well.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_History_File_DHF\"><\/span><b>Design History File (DHF)\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The DHF is specific to the US FDA. ISO 13486:2016 doesn\u2019t require the manufacturer to maintain a DHF.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A Design History File is maintained for each project which includes all the deliverables of each phase. It includes the latest product information. The design and development documents shall be easily available and accessed as and when needed. Design and development contracts should explicitly specify the manufacturer\u2019s right to design information and establish standards for the form and content of design documentation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In practice, design controls provide managers and designers with improved visibility of the design process. With improved visibility, managers are empowered to more effectively direct the design process\u2014that is, to recognize problems earlier, make corrections, and adjust resource allocations. Designers benefit both by enhanced understanding of the degree of conformance of a design to user and patient needs, and by improved communications and coordination among all participants in the process.<\/span><\/p>\n<blockquote><p><strong>Need help understanding and implementing FDA Design Controls\u00a0 for your medical device? Contact experienced <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDADesignControl\">medical device consultants<\/a> on Kolabtree.\u00a0\u00a0<\/strong><\/p><\/blockquote>\n<p><b>References:\u00a0<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/116573\/download\"><span style=\"font-weight: 400;\">FDA, Design Control guidance for Medical Device Manufacturers<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Medical Regulatory Practices, An international perspective, Val Theisz\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/116762\/download\"><span style=\"font-weight: 400;\">Design Control, presentation by Joseph Tartal<\/span><\/a><br \/>\n3a. <a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-1996-10-07\/pdf\/96-25720.pdf\"><span style=\"font-weight: 400;\">Federal Register \/ Vol. 61, No. 195<\/span><\/a><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shreya Chenni, freelance regulatory writer for medical devices, provides a 10-minute guide to FDA design controls for your medical device.\u00a0\u00a0 One of the major causes of medical device recalls is the lack of design control as identified by the FDA [3,3a]. The pre-production controls were then added to the device GMP regulations. Design controls are<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":8131,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[],"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>A guide to FDA Design Controls for your medical device<\/title>\n<meta name=\"description\" content=\"How to ensure you meet FDA Design Controls for your medical device development. Understand user needs, design input, design output, verification, 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\/a-guide-to-fda-design-controls-for-your-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A guide to FDA Design Controls for your medical device\" \/>\n<meta property=\"og:description\" content=\"How to ensure you meet FDA Design Controls for your medical device development. Understand user needs, design input, design output, verification, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-fda-design-controls-for-your-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-07-28T10:59:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-28T11:08:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/FDA-design-controls.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"A guide to FDA Design Controls for your medical device","description":"How to ensure you meet FDA Design Controls for your medical device development. 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