OTS Software Guidance Update Underscores Industry Advancements
The Off-the-Shelf Software Guidance updates highlight industry advancements.
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The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.
After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.
New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears
With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers. Medtech Insight’s round-up of four device-specific documents is below.