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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

The Hazards of FDA’s When-to-File Policies for 510(k)s

Predetermined change control plans (PCCPs) may be the way of the future for 510(k) medical device software, but the vast majority of both hardware and software device products still do not incorporate a PCCP. As a consequence, the FDA’s existing policies for when to file a new 510(k) are still in effect, and this blog will provide a closer look at the related guidances.

What Caption Health’s FDA Approval Reveals About Successful PCCPs

The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating products with a PCCP component for the U.S. market. The FDA approved the de novo application by Caption Health on Feb. 24, 2023, for a machine learning (ML) product that processes ultrasound images to calculate left ventricular ejection fraction (LVEF).