The August ’12 guideline on Refuse to Accept Policy for 510(k)’s

The August ’12 guideline on Refuse to Accept Policy for 510(k)’s

On August 10, 2012, the FDA issued new guidelines on Refuse to Accept Policy for 510(k)’s. This updated guideline, which is currently a draft, will supersede earlier guidelines on the subject, namely Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy, dated June 30, 1993, and 510(k) Refuse to Accept Procedures (K94-1) blue book memo, dated May 20, 1994 when completed.

A two-week deadline to the FDA

What is this new guideline? It offers the FDA a 15-day window to inform manufacturers of medical devices who have applied for premarket notification of their devices, whether their submission is administratively correct. What this means is that manufacturers should take note of checklists issued by the FDA based on regulatory requirements. These cover traditional, abbreviated and special 510(k)’s.

Not every element is mandatory

Based on these checklists, a manufacturer should submit applications for premarket approval of its devices. If there is a particular part of the required guideline that is not submitted, it should offer a justification to the FDA explaining the rationale for non-submission of this particular item. Typically, elements which are not applicable to all devices, such as in the case of biocompatibility testing are ones that normally get excluded.

What does the FDA do?

Within 15 days of receiving a submission for premarket approval, the FDA has to issue a notice to the manufacturer, stating that the submission is fine administratively. This does not amount to validation of the product, nor that the product met regulatory requirements. What this endorsement means is that the FDA certifies that the manufacturer met the right submission procedures. This means that the right steps for submission were followed. This in no way amounts to product approval, which is a long and winding procedure for which the FDA is not set any deadline.

It should indicate to the manufacturer if any element is missing in the submission. If the submitter fills in the missing information; a new submission is not necessary. If no response is had from the FDA in two weeks; it can be assumed that the submission was technically alright. This does not prevent the FDA from responding with its set of reservations even after two weeks, although such cases are rare.


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