Risk-Averse FDA Strangles 510(k) Process, New Citizen’s Petition Charges

A citizen’s petition filed by Minneapolis law firm DuVal & Associates challenges several aspects of the 510(k) process, charging that current practices effectively overstep CDRH’s statutory boundaries and insert the agency into the practice of medicine.

The petition asks the FDA to hold off on implementing the December 2011 draft guidance on determining substantial equivalence and instead abide by pre-2009 documents on the 510(k) process. It also requests an ongoing training program involving both FDA and industry and a review of 510(k) program staff that considers possibly contracting out review work.

Attorney Mark DuVal said his concerns are systemic, rather than being tied to any single device or therapeutic segment. While he’s seen improvements from upper-level FDA management since passage of reform legislation tied to MDUFA, he feels the message has yet to filter down to rank-and-file reviewers.

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