FDA Final Guidance on Acceptance and Filing Criteria for 510(k)s and PMAs
Dec. 31, 2012
Dear Medical Device Establishments,
Today the FDA published two final guidance documents that explain the procedures and criteria FDA intends to use in assessing whether PMA and 510(k) submissions are sufficiently complete for the agency to undertake substantive reviews.
The first of the guidance documents is the Final Guidance for Industry and Food and Drug Administration Staff: Acceptance and Filing Review for Premarket Approval Applications (PMAs). This guidance is intended to clarify the criteria that FDA will use for accepting and filing PMAs. The guidance and associated checklists identify the necessary elements and contents of a complete PMA application. It is applicable to original PMAs and PMA panel-track supplements reviewed in CDRH and CBER.
The second guidance is the Final Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s. This guidance clarifies the necessary elements and contents of a complete 510(k) submission. The elements and contents outlined are applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER, and they have been compiled into checklists for use by FDA review staff.
Today’s final guidance documents address the concerns and comments that the FDA received on the draft guidances as well as feedback received during informal discussions with industry. In response to these comments, both documents were revised to clarify the criteria and processes.
For more information about FDA’s implementation of MDUFA III, please see:
Sincerely,Food and Drug AdministrationCenter for Devices and Radiological Health Contact: email@example.comPhone Toll Free 1-800-638-2041 or1-301-796-7100