Coalition Questions FDA’s Draft Guidance on Abbreviated 510(k) Program

An industry coalition asked the FDA to clarify its proposal to expand the Abbreviated 510(k) program by allowing the use of performance criteria for demonstrating substantial equivalence.

The Bringing Real-World Insight for Device Governance and Evaluation (BRIDGE) Coalition said more public input is needed to decide which products should be eligible for the program.

The FDA should expand on the definitions and processes within the guidance, such as when additional data is required and how criteria will be established, the coalition said.

It said it was “looking for information on why this new approach will be of use to FDA and stakeholders,” and it questioned whether there could be a performance standard in situations where there is no predicate device.