{"id":8280,"date":"2020-09-01T08:53:58","date_gmt":"2020-09-01T08:53:58","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8280"},"modified":"2021-10-04T07:45:19","modified_gmt":"2021-10-04T07:45:19","slug":"fda-software-documentation-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/","title":{"rendered":"\u00a0FDA Software Documentation for Medical Devices"},"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-69f1aa0fa3e82\" 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-69f1aa0fa3e82\"><\/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\/fda-software-documentation-for-medical-devices\/#How_to_classify_your_medical_device_software\" title=\"How to classify your medical device software?\u00a0\">How to classify your medical device software?\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#FDA_software_documents_for_medical_devices\" title=\"FDA software documents for medical devices\">FDA software documents for medical devices<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#What_are_the_documents_to_be_submitted\" title=\"What are the documents to be submitted?\">What are the documents to be submitted?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#Description_of_the_documents\" title=\"Description of the documents\u00a0\">Description of the documents\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#1_Level_of_Concern\" title=\"1. Level of Concern\u00a0\">1. Level of Concern\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#2_Software_Description\" title=\"2. Software Description\">2. Software Description<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#3_Device_Hazard_Analysis\" title=\"3. Device Hazard Analysis\u00a0\">3. Device Hazard Analysis\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#4_Software_Requirements_Specification\" title=\"4. Software Requirements Specification\">4. Software Requirements Specification<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#5_Architecture_Design_Chart\" title=\"5. Architecture Design Chart\">5. Architecture Design Chart<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#6_Software_Design_Specifications_SDS\" title=\"6. Software Design Specifications (SDS)\">6. Software Design Specifications (SDS)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#7_Traceability_Analysis\" title=\"7. Traceability Analysis\">7. Traceability Analysis<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#8_Software_Development_Environment_Description_SDED\" title=\"8. Software Development Environment Description (SDED)\">8. Software Development Environment Description (SDED)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#9_Verification_and_Validation_Documentation\" title=\"9. Verification and Validation Documentation\">9. Verification and Validation Documentation<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#10_Revision_Level_History\" title=\"10. Revision Level History\">10. Revision Level History<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/#11_Unresolved_Anomalies\" title=\"11. Unresolved Anomalies\u00a0\">11. Unresolved Anomalies\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDA-Doc\">regulatory writer<\/a> Shreya Chenni provides a guide to FDA software documentation for medical devices, including a breakdown of the requirements based on classification.\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">The <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">medical device<\/a> industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of a biological activity, and improved diagnostic accuracy. Some examples of AI-enabled applications or devices include Arterys Application, Philips WSI and QuantX by Quantitative Insights. The software has to be verified and validated, to ensure its safety and effectiveness.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For any device that contains software going through the <a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/\">510(k) route<\/a>, specific software-related documents have to be submitted. In this article we discuss the documents required for <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k) submissions<\/a> and understand how to draft them based on your software classification.\u00a0\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_classify_your_medical_device_software\"><\/span><b>How to classify your medical device software?\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Identify the applicable Level of Concern (LoC). There are three levels:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Major: a failure or latent flaw could directly result in death or serious injury to the patient or operator\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">OR\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Moderate: a failure or latent design flaw could directly result in minor injury to the patient or operator<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u00a0OR\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Minor:\u00a0 if failures or latent design flaws are unlikely to cause any injury to the patient or operator.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Use the Table 1 and Table 2 of the <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices<\/span><\/a><span style=\"font-weight: 400;\"> to answer the questions and determine your Software Level of Concern.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_software_documents_for_medical_devices\"><\/span><b>FDA software documents for medical devices<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"What_are_the_documents_to_be_submitted\"><\/span><span style=\"font-weight: 400;\">What are the documents to be submitted?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Softwares of moderate and major level of concern have 11 different documents to be submitted. Whereas, software under minor level of concern requires seven different documents. The scope and extent of detailing in these documents varies based on their LoC.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The following table identifies the documents required for each of the levels of concern:\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Minor<\/b><\/td>\n<td><b>Moderate<\/b><\/td>\n<td><b>Major<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Level of Concern<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Level of Concern<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Level of Concern<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Software Description<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Description<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Description<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Device Hazard Analysis<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Device Hazard Analysis<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Device Hazard Analysis<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Software Requirements Specification (SRS)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Requirements Specification (SRS)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Requirements Specification (SRS)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Traceability Analysis<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Traceability Analysis<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Traceability Analysis<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Verification and Validation Documentation\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Verification and Validation Documentation\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Verification and Validation Documentation\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Revision Level History\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Revision Level History\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Revision Level History\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Architecture Design Chart<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Architecture Design Chart<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software design specification document<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software design specification document<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Development Environment Description\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Software Development Environment Description\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Unresolved Anomalies (Bugs or Defects)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Unresolved Anomalies (Bugs or Defects)<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Description_of_the_documents\"><\/span><b>Description of the documents\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_Level_of_Concern\"><\/span><b>1. Level of Concern\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Record the answers to the questions in Table 1 and Table 2 of the <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices<\/span><\/a><span style=\"font-weight: 400;\">\u00a0 in this document. Include a rationale for the determined level of concern.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Software_Description\"><\/span><b>2. Software Description<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This document introduces the device software and hence should provide a comprehensive overview of the features, functionalities, intended use. Include programming language, hardware platform, operating system and use of Off-the-Shelf software as applicable. Figures and diagrams should be included as appropriate.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In case the device uses Off-the-Shelf software refer to the FDA guidance document \u201c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/shelf-software-use-medical-devices\">Guidance for Off-the-Shelf Software Use in Medical Devices<\/a>.\u201d\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Device_Hazard_Analysis\"><\/span><b>3. Device Hazard Analysis\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0A device hazard analysis is a must. All the foreseeable hazards associated with the intended use of the device (software and hardware) should be captured. The risk analysis should be conducted in compliance with ISO 14971. The hazard analysis should identify the hazard, hazardous, severity of the hazard, cause of the hazard, risk control measure and verification of the control measure.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Software_Requirements_Specification\"><\/span><b>4. Software Requirements Specification<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The Software Requirements Specification (SRS) documents all the requirements for the software. Basically, the requirements describe what the software should do. Requirements can be put into different buckets such as functional, performance, user interface and regulatory.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For minor LoC the SRS can be a summary of functional requirements, however for moderate and major the requirements have to be detailed and typically listed. Ensure that each requirement listed has a requirement ID assigned to it such as SRS-01, SRS-02 and so on.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Here are few examples of the SRS:\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hardware requirements: Include the requirements about &#8211;\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> microprocessors\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> memory devices<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> sensors\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> energy sources\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> safety features<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> communications<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Programming requirements: Include the program size requirements, restrictions and so on\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Interface requirements: Include requirements that describe the communication between the software and hardware devices such as printers, monitors. Other requirements such as the operating system the software is compatible with and so on.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Software Performance and Functional Requirements Software performance and functional requirements include algorithms or control characteristics for therapy, diagnosis, monitoring, alarms, analysis, and interpretation with full text references or supporting clinical data, if necessary.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Software performance and functional requirements may also include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Device limitations due to software\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Internal software tests and checks<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Error and interrupt handling\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Fault detection, tolerance, and recovery characteristics 12 Contains Nonbinding Recommendations\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Safety requirements<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Timing and memory requirements\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identification of off-the-shelf software, if appropriate.\u00a0<\/span><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"5_Architecture_Design_Chart\"><\/span><b>5. Architecture Design Chart<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0This document clearly presents the relationship, flow of data and interaction between the major components or functional blocks of the software. This is usually depicted in the form of flowchart, block diagrams and other forms as appropriate. For moderate and major level of concern software, the design chart can include state diagrams.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6_Software_Design_Specifications_SDS\"><\/span><b>6. Software Design Specifications (SDS)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The implementation of the requirements is detailed in this document. Each SDS shall be numbered, such as SDS-01, similar to the SRS. Each requirement included in the SRS should have a corresponding design specification. However, it is also possible that a single design specification can correspond to a group of requirements.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"7_Traceability_Analysis\"><\/span><b>7. Traceability Analysis<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This document links the requirements, design specification, hazards and V&amp;V tests. The traceability matrix can be drafted as below, details can be added as appropriate:\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400;\">User need (optional)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Hazards<\/span><\/td>\n<td><span style=\"font-weight: 400;\">V&amp;V test cases<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Haz-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-001<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SDS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Haz-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">TC-004<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"8_Software_Development_Environment_Description_SDED\"><\/span><b>8. Software Development Environment Description (SDED)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Moderate and major level of concern software are required to submit a SDED which describes software development life cycle plan, maintenance and software activities. The level of detailing differs for Moderate and Major. Refer to EN 62304 Table 1: Table A.1 \u2013 Summary of requirements by software safety class. This can be used to identify the elements to be included and the activities that are to be documented per their class. The three classes A, B and C align with the FDA\u2019s level of concern.\u00a0<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"9_Verification_and_Validation_Documentation\"><\/span><b>9. Verification and Validation Documentation<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Minor LoC: Document device level testing and integration testing (if applicable). Ensure the test cases have an acceptance criteria and summary of test results.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Moderate LoC: Document summary list of validation and verification activities and their results. Include acceptance criteria. Ensure that Traceability Analysis references test case IDs.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Major LoC: In addition to information above (Moderate LoC), description of any failed tests and changes made in response to these should be documented.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"10_Revision_Level_History\"><\/span><b>10. Revision Level History<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Document the major changes to the software ensuring that the last line time\/entry is the latest version of the software. Identify the version number, date and describe the changes with respect to the prior version.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"11_Unresolved_Anomalies\"><\/span><b>11. Unresolved Anomalies\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Document the unsolved bugs existing in the software being released. Capture the following for each bug:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The problem<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Impact on device performance\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Planned timelines to correct these bugs (if applicable)\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The above eleven documents cover the entire documentation necessary for the device software. Additionally, FDA requires Cybersecurity Documentation such as cybersecurity plan, risk management and V&amp;V tests and their results. For more information on this FDA guidelines on Cybersecurity requirements refer to: <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/content-premarket-submissions-management-cybersecurity-medical-devices\"><span style=\"font-weight: 400;\">Content of Premarket Submissions for Management of Cybersecurity in Medical Devices<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">References:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices<\/span><\/a><\/li>\n<\/ul>\n<blockquote><p><strong>Need help with FDA software documentation for medical devices? Get in touch with freelance regulatory writers and <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">FDA submission experts<\/a> on Kolabtree.<\/strong><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Freelance regulatory writer Shreya Chenni provides a guide to FDA software documentation for medical devices, including a breakdown of the requirements based on classification.\u00a0 The medical device industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/fda-software-documentation-for-medical-devices\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":8292,"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) - 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