ARTICLE SUMMARY:
FDA emphasized the importance of minding postmarket safety problems for potential predicate devices, among other issues, in new draft guidelines on the 510(k) Program published September 6. Here are four observations from Market Pathways on the agency’s latest efforts to fine-tune its workhorse regulatory pathway.
The 510(k) modernization train is on the move again. FDA rolled out its latest effort to refine and clarify the much-used, 40-year-old regulatory pathway to match the needs of the current medtech development landscape with the September 6 publication of three new draft guidance documents.
Specifically, the three drafts are:
