A Minneapolis law firm has filed a joint petition on behalf of a group of pre-revenue, small and midsized device companies, venture capitalists and inventing physicians that aims to prevent the U.S. Food and Drug Administration from unlawfully changing how the 510(k) program operates.
The Minnesota Medical Device Alliance (MMDA) filed the citizen petition and stay of action with the FDA to “challenge and force discontinuation of the administrative practices and definitional interpretations that FDA has put into practice since 2009 in reviewing 510(k)s, which have dramatically changed the manner in which the 510(k) program operates,” reads the petition filed by Duval & Associates, the law firm representing the MMDA.
Here are some topics that the petition includes:
- Reinterpreting FDA’s view of “general versus specific intended use,” which is applied so narrowly that FDA now considers almost every new indication for a 510(k) device to be a new intended use such that the agency can then conclude the applicant has no legally marketed predicate device to which it can claim Substantial Equivalence;
- Allowing FDA review staff to inappropriately consider clinical utility/benefit and, in the case of in vitro diagnostics, clinical truth and operational truth, as part of the SE criteria, which is inconsistent with the statute and the opinion of the FDA’s Office of Chief Counsel (in the ReGen opinion), and allows FDA to essentially engage in the practice of medicine in determining which devices medical practitioners should use;
- Allowing FDA review staff to inappropriately consider statutes and regulatory matters extraneous to the SE decision (e.g., cGMP/Quality Systems, MDR, FD&C Act advertising and promotion, and OSHA regulations or CDC guidance);
- Inappropriately applying risk mitigation and “assurance case” principles to the criteria for 510(k) clearance;
- More restrictively interpreting when a device has a new technological characteristic and when those technological characteristics raise new questions of safety and effectiveness.
Here’s the full text of the petition.