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GUIDANCE DOCUMENT

Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff September 2019

Final
Docket Number:
FDA-2012-D-0523
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The new policies regarding the factors to consider when determining if a change to an existing device is appropriate for submission through the Special 510(k) pathway will be operationalized immediately. However, we recognize and anticipate that both FDA and industry may need up to 60 days to operationalize the associated updates to the 510(k) RTA guidance. As a result, if a 510(k) is received by the FDA before or up to 60 days after the publication of this guidance and does not include all criteria necessary to meet a minimum threshold of acceptability as outlined in the updated RTA guidance, the FDA may decide not to refuse to accept.

Until November 13, 2019, once FDA has determined a submission is appropriate for review as a Special 510(k) as described in the Special 510(k) Program guidance, and for all other 510(k) submission types, FDA intends to utilize the prior final RTA guidance to assess whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for 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. Moreover, with the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA agreed to performance goals based on the timeliness of reviews. Acceptance review therefore takes on additional importance in both encouraging quality submissions from submitters of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.

Therefore, the current 510(k) Refuse to Accept (RTA) policy includes 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). In order to enhance the consistency of our acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, this guidance, including the checklists included in the appendices, clarify the necessary elements and contents of a complete 510(k) submission. The process we outline is applicable to all devices reviewed through the 510(k) notification process and has been compiled into checklists for use by FDA review staff.

It is critical to distinguish between the completeness of the regulatory submission, and the quality of the data provided and any studies conducted in support of the submission. The assessment of the completeness of the 510(k) occurs during the acceptance review, while the assessment of the quality of the submitted information occurs during the substantive review. FDA will base acceptance on the objective criteria outlined in the associated Acceptance Checklist and not on the quality of the data.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0523.