A primer on FDA’s accessories classification process and regulatory confusion

By Laura DiAngelo, MPH

FDA has proposed a new list of medical device accessories that could qualify for Class I classification separately from their parent devices, while offering additional detail on how it evaluates eligibility.

But the latest proposal also brings longstanding questions about the agency’s classification approach back into focus, including how FDA distinguishes device-specific accessories and when design controls affect eligibility for Class I status.

This AgencyIQ analysis unpacks the regulatory history behind the current proposal, where uncertainty remains and what FDA’s evolving approach could mean for device manufacturers.

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