510(k), PMA Acceptance Guidelines Finalized as of First of Year

January 8, 2013
FDA reviewers evaluating completeness of 510(k) submissions should consider only the presence of required information, and not whether it appears to be adequate, according to a final guidance on the agency’s 510(k) refuse-to-accept policy. The guidance was one of two final documents released Dec. 31. The other deals with PMA applications. Both guidances were released in draft form last summer.
Devices & Diagnostics Letter