{"id":4309,"date":"2021-11-12T12:02:00","date_gmt":"2021-11-12T12:02:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4309"},"modified":"2025-12-02T12:04:57","modified_gmt":"2025-12-02T12:04:57","slug":"guidance-on-premarket-submission-for-device-software-functions","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/guidance-on-premarket-submission-for-device-software-functions\/","title":{"rendered":"Guidance on Premarket Submission for Device Software Functions"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-bda041eedca2e18b8c00e81245e52fc8 wp-block-paragraph\">This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD) and software as a medical device (SaMD), and summarizes the types of information typically produced during software design, development, verification, and validation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Documentation Level<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The level of documentation required depends on the device\u2019s risk to patients, users, or others in the use environment. FDA evaluates four risk-based factors to determine whether a device requires Basic Documentation or Enhanced Documentation. This classification helps identify the minimum amount of information appropriate for a software\u2011inclusive premarket submission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Documentation Level is determined by the intended use of the device as a whole rather than the intended use of individual software functions. Basic Documentation applies when Enhanced Documentation is not necessary. Enhanced Documentation must be provided when the device\u2019s risk profile warrants it.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Recommended Documentation<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Submitted documentation should demonstrate that software development followed structured engineering practices, including traceability, planning, requirements definition, risk assessment, design review, change control, verification and validation testing, and other measures ensuring that the software is properly designed and functions as intended. This information supports FDA\u2019s assessment of whether the device software is safe and effective.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Documentation Level Statement<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Submissions should include a clear statement identifying the Documentation Level (Basic or Enhanced) and a justification for the classification.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Software Description<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A high-level description of software functionality should be included, supported by diagrams, flowcharts, state charts, and other visuals as needed to explain operationally significant features. For modified devices, the submission should reference prior FDA submissions and highlight relevant software changes since the most recent clearance or approval.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sponsors may use the guiding questions provided in the draft guidance to ensure complete descriptions, while recognizing that additional device\u2011specific information may be useful to support FDA\u2019s understanding.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-a3ffc875c7a614ded36354cdc1b42bb4 wp-block-paragraph\">For multiple function device products that contain \u201cother functions,\u201d as described in FDA\u2019s guidance on Multiple Function Device Products, sponsors should incorporate the applicable recommendations from that document when preparing software description materials.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-063c43e30005e18537946fce2c4d9b3a wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><strong><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\">Tags:<\/mark><\/strong> <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/fda-medical-device-clinical-regulations\/\" rel=\"tag\">FDA Medical Device clinical Regulations<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/fda-submission-guidance\/\" rel=\"tag\">fda submission guidance<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/guidance-document-pertain-to-device-software-functions\/\" rel=\"tag\">guidance document pertain to device software functions<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/guidance-on-premarket-submission\/\" rel=\"tag\">Guidance on premarket submission<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-device\/\" rel=\"tag\">Medical Device<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/software-design-specification-medical-device\/\" rel=\"tag\">software design specification medical device<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/software-in-a-medical-device\/\" rel=\"tag\">software in a medical device<\/a><\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD) and software as a medical device (SaMD), and summarizes the types of information typically produced during software design, development, verification, and validation. Documentation Level The level of documentation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[396,394,391,395,90,392,393],"class_list":["post-4309","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-fda-medical-device-clinical-regulations","tag-fda-submission-guidance","tag-guidance-document-pertain-to-device-software-functions","tag-guidance-on-premarket-submission","tag-medical-device","tag-software-design-specification-medical-device","tag-software-in-a-medical-device"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Guidance on Premarket Submission for Device Software Functions<\/title>\r\n<meta name=\"description\" content=\"This guidance identifies the 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