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# Lawyer Faults ‘New’ FDA Approach to 510(k)s
- URL: https://www.fdaweb.com/lawyer-faults-new-fda-approach-to-510-k-s/
- Published: 2017-09-21T12:00:00.000Z
- Updated: 2026-09-14T22:51:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139679

Attorney **Mark DuVal** (DuVal & Associates) faults FDA for what he contends is its recent adoption of a “shut down” mentality when reviewing medical device 510(k) submissions. “They often spend much of their time trying to conjure up countervailing arguments why a device does not belong on the 510(k) pathway,” DuVal writes in a 9/20 [Client Alert](http://duvalfdalaw.com/?ref=fdaweb.com). “Rather than being open-minded about the possibility, FDA reviewers often expend intellectual capital trying to defeat the sponsor’s argument. Fortunately, more experienced and collaborative FDA management will listen to strong arguments and intervene or overturn the review staff.”

According to DuVal, the current FDA administration has made the 510(k) program something it was not intended to be — high science and making a mystery out of something that is known. “FDA frequently contorts its definitional and scientific analysis to find a device somehow has different technological characteristics and raises new questions of safety and effectiveness,” he writes. “FDA often uses this analysis to bounce a device off the 510(k) path and on to either the *de novo* or PMA path.”

The alert says it seems as though the agency, rather than taking a common-sense approach, starts with a presumption that a device is different from its predicate and raises different questions of safety and effectiveness, “eliminating the collaborative aspect, flexibility, and practicality of the 510(k) program.” DuVal says that the predisposition to find differences versus similarities runs counter to the underlying premise for the 510(k) program.

He raises three concerns with the agency’s interactive approach and suggests how to challenge them: **(1)** FDA often finds differences without articulating why, **(2)** FDA elevates theory over scientific data and that ignores the hierarchy of evidence/proof, and **(3)** FDA often inappropriately cites literature or increased risk to support its position.