CDRH Revises its 'Refuse to Accept' Policy for 510(k)s

CDRH has revised its procedures and criteria it intends to use in assessing whether a 510(k) submission meets an “acceptability level” for a substantive review. “Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible,” the Center’s Refuse to Accept Policy for 510(k)s draft guidance says.

The guidance revision was mandated by the recent reauthorization of the device user fee program to help improve CDRH’s performance goals based on review timeliness. “Acceptance review therefore takes on additional importance in both encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions,” the guidance says. “Therefore, we have modified our 510(k) Refuse to Accept policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s).”

The guidance includes checklists to help clarify the necessary elements and contents of a complete 510(k) submission. It may be accessed online.