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)
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/
- 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.
Following the webinar, a transcript, recording and slides will be available at:http://www.fda.gov/CDRHWebinar
If you have specific questions regarding obligations associated with these statutory requirements, please contact CDRH at CDRHProductJurisdiction@fda.
Food and Drug Administration
Center for Devices and Radiological Health