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After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance.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.

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.