--- title: US FDA Drafts Guidance on Medical Device Software Functions description: The United States Food & Drug Administration has issued Draft Guidance on the content of premarket submissions for device software functions. image: https://go.adherent.com/hubfs/md%20us%20fda.png --- [![](https://www.complianceandrisks.com/wp-content/themes/compliancerisk/inc/img/general/compliancelogo.svg)](https://www.complianceandrisks.com/) - Products Products - - [C2P](https://www.complianceandrisks.com/c2p-compliance-knowledge-management-platform/) - [Regulations Management](https://www.complianceandrisks.com/solutions/conquering-the-regulatory-avalanche/) - [Standards Management](https://www.complianceandrisks.com/solutions/standards/) - [Requirements Management](https://www.complianceandrisks.com/solutions/heres-the-regulation-whats-next/) - [Regulatory Topics](https://www.complianceandrisks.com/solutions/regulated-areas/) - [WFSGI Compliant Labelling Requirements Database](https://www.complianceandrisks.com/WFSGI/) - Services Services - [Market Access Service](https://www.complianceandrisks.com/solutions/grow-in-new-markets/) - [Regulatory Process Consulting](https://www.complianceandrisks.com/solutions/best-practices-in-compliance-processes/) - [Environmental, Health & Safety (EH&S)](https://www.complianceandrisks.com/solutions/ehs-and-your-legal-registers/) - [Managed Services](https://www.complianceandrisks.com/solutions/solutions-for-every-day/) - [Training and Systems Implementation](https://www.complianceandrisks.com/solutions/training-and-systems-implementation/) - [Ask Our Experts](https://www.complianceandrisks.com/solutions/your-compliance-question) - Resources News & Resources - [Blog](https://blog.complianceandrisks.com/news-resources?__hstc=67571022.c37393069837d66fdddfdab74b5ad3c6.1593078357468.1593078357468.1593078357468.1&__hssc=67571022.1.1593078357469&__hsfp=693435645) - [Commentary & Analysis](https://blog.complianceandrisks.com/commentary-analysis?__hstc=67571022.c37393069837d66fdddfdab74b5ad3c6.1593078357468.1593078357468.1593078357468.1&__hssc=67571022.1.1593078357469&__hsfp=693435645) - [COVID-19](https://www.complianceandrisks.com/covid-19/) - [Webinars](https://www.complianceandrisks.com/webinars/) - [White Papers & eBooks](https://www.complianceandrisks.com/whitepapers/) - [About](https://www.complianceandrisks.com/about/) Compliance & Risks - [About Us](https://www.complianceandrisks.com/about/) - [Industries](https://www.complianceandrisks.com/compliance-requirements-industries/) - [History](https://www.complianceandrisks.com/compliance-and-risks-history/) - [Careers](https://www.complianceandrisks.com/compliance-risks-careers/) - [Knowledge Partners](https://www.complianceandrisks.com/knowledge-partners/) - [Partners & Affiliates](https://www.complianceandrisks.com/becoming-a-compliance-risks-partner/) - [Get in touch](https://www.complianceandrisks.com/contact/) COVID-19 Regulatory Developments [Find Out More](https://www.complianceandrisks.com/covid-19/) - [Book a demo](https://www.complianceandrisks.com/book-a-demo/) - [Eng](https://complianceandrisks.com) - [日本語](http://complianceandrisks.jp/) ![](https://www.complianceandrisks.com/wp-content/themes/compliancerisk/inc/img/general/burger.svg) Search for: # US FDA Drafts Guidance on Medical Device Software Functions --- ##### 09 December 2021 ![md us fda](https://go.adherent.com/hs-fs/hubfs/md%20us%20fda.png?width=280&name=md%20us%20fda.png)In November 2021, the United States Food & Drug Administration issued Draft Guidance on the content of premarket submissions for device software functions. The purpose of this Draft Guidance is to describe FDA's thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions. FDA refers to a software function that meets the definition of a device as a "device software function." For example, a device software function may control hardware devices or be part of a hardware device (i.e., Software in a Medical Device, or SiMD) or be a device without being part of a hardware device (i.e., Software as a Medical Device, or SaMD). For any given product, the term "function" is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. For example, a product with an intended use to analyze data has one function: Analysis. A product with an intended use to store, transfer and analyze data has three functions: (1) Storage, (2) Transfer and (3) Analysis. As this example illustrates, a product may contain multiple functions. The Guidance is intended to cover: - Firmware and other means for software-based control of medical devices; - Stand-alone software applications; - Software intended to be operated on general-purpose computing platforms; - Dedicated hardware/ software medical devices; and - Accessories to medical devices when those accessories contain or are composed of software. When possible, FDA harmonized the terminology and recommendations in this guidance with software-related consensus standards, such as: - ANSI/AAMI/ISO 14971, Medical devices - Applications of risk management to medical devices; - ANSI/AAMI/IEC 62304, Medical Device Software - Software Life Cycle Processes; and - ANSI/AAMI SW91, Classification of defects in health software. When finalized, this Guidance will replace FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on 11 May 2005. Comments may be submitted through 22 February 2022, with instructions provided in the the [Federal Register notice.](https://www.federalregister.gov/documents/2021/11/04/2021-24061/content-of-premarket-submissions-for-device-software-functions-draft-guidance-for-industry-and-food) Sources: - [Content of Premarket Submissions for Device Software Functions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions) - [Content of Premarket Submissions for Device Software Functions: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.fda.gov/media/153781/download) To stay on top of the latest news and developments on Medical Devices and other regulations from across the globe, [**sign up to our newsletter!**](https://www.complianceandrisks.com/newsletter-sign-up/)    ![Picture of Compliance & Risks](https://go.adherent.com/hubfs/Blue%20C%20logo%20on%20its%20own%20250-213769-edited.jpg) ### Written by [Compliance & Risks](https://go.adherent.com/news-resources/author/compliance-risks) [Facebook](https://www.facebook.com/complianceandrisks/) [LinkedIn](https://www.linkedin.com/company/compliance-and-risks/) [Twitter](https://twitter.com/ComplianceRisks) - - - - ## Featured Posts --- ![Stacey Bowers to Present at ICPHSO 2022 Annual Meeting & Training Symposium](https://go.adherent.com/hubfs/icphso%202022%20(1).png) [Stacey Bowers to Present at ICPHSO 2022 Annual Meeting & Training Symposium](https://go.adherent.com/news-resources/stacey-bowers-to-present-at-icphso-2022-annual-meeting-training-symposium) 26 January 2022 ![Regulating Explosive Atmospheres in the Workplace](https://go.adherent.com/hubfs/Regulating%20Explosive%20Atmospheres%20in%20the%20Workplace.png) [Regulating Explosive Atmospheres in the Workplace](https://go.adherent.com/news-resources/regulating-explosive-atmospheres-in-the-workplace) 25 January 2022 ![What's Trending in Product Compliance?](https://go.adherent.com/hubfs/Trending%20Jan%2022.png) [What's Trending in Product Compliance?](https://go.adherent.com/news-resources/whats-trending-in-compliance-jan-22) 24 January 2022 #### Ireland Office   Unit 9 Eastgate Avenue Eastgate Business Park Little Island Cork Ireland +353 (0)21 435 1990 [info@complianceandrisks.com](mailto:info@complianceandrisks.com) #### US Offices   New York 50 Fountain Plaza Suite 1400 Buffalo NY 14202 +1 716 939 1951   California P.O.Box 309 8712 Marysville Road Oregon House, CA 95962 – 0309 +1 530 216 4455 [![Compliance Logo](https://go.adherent.com/hubfs/Compliance_and_Risks_January2018/Images/compliancelogo.svg)](http://www.complianceandrisks.com/) #### Information - [Solutions](https://www.complianceandrisks.com/c2p-platform/) - [Industries](https://www.complianceandrisks.com/industry-solutions/) - [News & Resources](https://www.complianceandrisks.com/resources/) - [About Us](https://www.complianceandrisks.com/about-us/) - [Get in touch](https://www.complianceandrisks.com/contact/) - [About Us](http://www.complianceandrisks.com/about/) - [Get in touch](http://www.complianceandrisks.com/contact/) [![Compliance Logo](https://go.adherent.com/hubfs/Compliance_and_Risks_January2018/Images/compliancelogo.svg)](http://www.complianceandrisks.com/) © 2021 Compliance and Risks Ltd. | [Privacy Policy](http://www.complianceandrisks.com/privacy-policy/)