The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The guidance emphasizes a risk-based approach to regulating such products, new legislative mandates and to acknowledge other guidances that have been published since an earlier version of the guidance was issued in 2005.
The final guidance supersedes the 2005 document, and includes several revisions from a draft version released for comment in 2021. While the 2005 guidance explained what documentation sponsors should consider providing in their application based on the agency’s definition of “levels of concern,” the new guidance does away with that and instead focuses on a risk-based approach that urges sponsors to think about the total product lifecycle (TPLC) of the device and how software plays into that. (RELATED: FDA issues draft guidance for device software in premarket submissions, Regulatory Focus 4 November 2021) …
