- March 19, 2018
8:00 PM - 8:00 PM ET
On January 30, 2018, the FDA issued 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.
On Tuesday, March 20, 2018, the FDA hosted a webinar for manufacturers and others interested in learning more about the statutory changes related to combination products included in these guidances.
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar.
As always, we appreciate your feedback; following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience.
If you have specific questions regarding obligations associated with these statutory requirements, please contact CDRH at CDRHProductJurisdiction@fda.hhs.gov.