Before submitting a Premarket Approval (PMA) or 510(k) Premarket Notification for review by the Food and Drug Administration (FDA), it is necessary to have an understanding of the FDA acceptance review process and requirements. In late 2012, FDA released two guidance documents1,2 that outline the initial step in the PMA and 510(k) review processes, the PMA Acceptance Review and the 510(k) Refuse to Accept (RTA) policy/designation, respectively.
What Is It?
Acceptance reviews—or Refuse to Accept (RTA)—apply specific predefined acceptance criteria to ensure submissions meet a minimum threshold for quality and completeness. This process allows FDA to appropriately assign resources and meet their commitment to timeliness as described in the Medical Device User Fee Amendments of 2012 (MDUFA III).3,4 Acceptance reviews apply to all original PMAs (including modular PMAs5) and panel-track PMA supplements, as well as Traditional, Special and Abbreviated 510(k)s. Quality submissions are complete, clearly organized, easy to understand and supported by the appropriate data.
The acceptance review begins immediately after the submission is received and processed by FDA’s Document Control Center (DCC) and should be completed by FDA within 15 calendar days. Following this, the PMA filing review or the 510(k) substantive review will be initiated. If the acceptance review is not completed within 15 days, the submission will automatically proceed to filing (for PMAs) or substantive review (for 510(k)s) and the manufacturer will be notified in writing.
FDA Review Clock
For accepted submissions, FDA review clock will start on the date of receipt of the 510(k) notification or the most recent PMA submission that made the PMA complete. For submissions not accepted during the first acceptance review, and instead receive an RTA designation letter, FDA review clock start date will be postponed until all required data have been received and the submission has been accepted.
Figure 1. FDA Acceptance Review Clock
Manufacturers should complete the submission checklist relevant to their specific application and retain it for their records. The checklists are provided in the corresponding guidance documents and on the FDA website.6 Checklists help confirm that all the required information is included and provide documentation in the case of a dispute. Although not required, the completed checklist may also be included as part of the submission to aid the FDA reviewer. Upon passing the acceptance review, FDA will notify the applicant and begin the filing or substantive review process.
Unsuccessful FDA Acceptance Review
If the submission does not meet the prespecified criteria, FDA will provide a written notice which will include a copy of the acceptance review checklist indicating the specific information that was missing or inadequate. Unless otherwise indicated by FDA, responses and new information should be submitted under the originally issued submission number and an additional acceptance review will be conducted, again within 15 calendar days. Multiple acceptance reviews are allowed, but are not recommended. If a response is not received by FDA within 180 calendar days of non-acceptance, they will consider the submission withdrawn.
Tips for Submission
- Know the current requirements, guidance documents and recognized standards that are applicable to your device, and consider them during design and development whenever possible
- In the submission, clearly describe your device and what it does, including:
- Consistent Indications for Use statement throughout
- Clear diagrams/engineering drawings with dimensions
- Describe all accessories and system components
- Minimize discrepancies within the submission
- Plan ahead and allow time to go through the acceptance review checklist to ensure all criteria are met prior to sending to FDA
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- Contact Erika Huffman to learn more about this topic.
- Visit our Regulatory page to read more about the different types of regulatory services NAMSA can offer you.
- Download NAMSA’s white paper about The FDA Refuse to Accept Policy/Acceptance Review Process.
- US Food and Drug Administration. Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff. December 31, 2012. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313368.pdf [Supersedes Guidance for Industry and Staff: Premarket Approval Application Filing Review, May 1, 2003].
- US Food and Drug Administration. Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff. December 31, 2012. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf. [Supersedes Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy, June 30, 1993; and 510(k) Refuse to Accept Procedures (K94-1) blue book memo, May 20, 1994].
- US Food and Drug Administration. Medical Device User Fee Amendments 2012 (MDUFA III). Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/default.htm.
- US Food and Drug Administration. MDUFA III Commitment Letter. Available at: http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
- US Food and Drug Administration. Premarket Approval Application Modular Review. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm.
- US Food and Drug Administration. Acceptance Checklists for 510(k)s. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm071360.htm.