Praise, Suggestions for 510(k) Guidance

Washington Legal Foundation (WLF) says there is “much to commend” in an FDA draft guidance on when to submit a 510(k) for a change to an existing device. It also offers several suggested changes.

“While the current guidance document (issued in 1997) has served manufacturers well for many years,” WLF says, “it undoubtedly is in need of updating. Moreover, the draft guidance is a marked improvement over FDA’s ill-fated 2011 draft document, which the agency was eventually forced to withdraw in the face of congressional opposition.”

The group says it is particularly concerned by the guidance’s “offhanded reference to manufacturers’ alleged right to make unilateral changes to product labels.” It says that issue has serious implications for product liability litigation and recommends that the agency delete all references to unilateral label changes and instead address the issue in a separate, more comprehensive regulatory proceeding.