FDA Updated Guidances – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) and Refuse to Accept Policy for 510(k)s

Today the FDA will post the updated final guidance documents:

• Refuse to Accept Policy for 510(k)s
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

These guidance documents explain the procedures and criteria the FDA intends to use in accepting or refusing a 510(k) or PMA submission. It includes checklists to identify the necessary elements and contents of a complete application. The updates address provisions in the 21st Century Cures Act (Cures Act), which was enacted on December 13, 2016.  The Cures Act amended section 503(g) of the Food, Drug and Cosmetic Act (FD&C Act) and applies certain drug provisions to device-led combination products.

The updated guidance “Refuse to Accept Policy for 510(k)s” replaces the final guidance, “Refuse to Accept Policy for 510(k)s,” issued on August 4, 2015.  The updated guidance “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)” replaces the final guidance, “Premarket Approval Application Filing Review,” issued on December 31, 2012.  FDA recognizes that the Agency and industry may need up to 60 days to perform activities to operationalize the new policies within these guidances. If information regarding drug exclusivity or patents as outlined in these guidances is not included in a premarket submission received by FDA before or up to 60 days after publication, FDA intends to request such information during the review of the submission, as necessary.

WEBINAR: On Tuesday, March 20, 2018, the FDA will host a webinar for manufacturers and others interested in learning more about the statutory changes related to combination products included in these guidances. FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required.

• Date: Tuesday, March 20, 2018
• Time: 3 – 4:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-369-2040, International Callers Dial: 1-773-756-4813; Conference Number: PWXW6784811; Passcode: 1397061
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW6784811&p=1397061&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at:http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

Following the webinar, a transcript, recording and slides will be available at:http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

If you have specific questions regarding obligations associated with these statutory requirements, please contact CDRH at CDRHProductJurisdiction@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health