Suggestions for Device Guidance Changes

Abbott Quality & Regulatory says a draft FDA guidance on “Deciding When to Submit a 510(k) to an Existing Device” interprets a “major change in intended use” to be a type of change that “could significantly affect safety or effectiveness,” which is inconsistent with current regulatory language. In its comment letter, Abbott recommends revising the guidance to reflect the two distinct standards in the regulation and as expressed in a 1997 guidance document. It also suggests language changes involving general versus specific use, cumulative review of changes, listing changes, components and the use of that term in the guidance, and clarification of the level of specificity when a device-specific guidance is draft or final.

The Medical Device Manufacturers Association praises FDA for many aspects of the draft guidance, including using the 1997 so-called K-97 guidance as the foundation for the new effort. It suggests some wording changes involving documentation needed as part of the “cumulative changes” proposal.

Finally, Washington Legal Foundation says it “applauds the nature of the draft guidance, which provides device manufacturers with a roadmap in making decisions regarding the need to file a new 510(k).” It says the K-97 guidance was in need of updating, and says the draft is a marked improvement over a 2011 draft that FDA was forced to withdraw in the face of congressional opposition. The letter says WLF is concerned about the draft’s “offhanded reference to manufacturers’ alleged right to make unilateral changes to product labels. That issue has serious implications for products-liability litigation. WLF urges FDA to delete all references to unilateral label changes and instead address that issue in a separate, more comprehensive regulatory proceeding.”