The FDA has a raft of guidances in the works, according to Center for Devices & Radiological Health director Dr. Jeffrey Shuren, adding to the stream of draft guidances from the past few months.
The agency hopes to get the de novo process "back on track," address clinical data expectations for 510(k) review and establish standards for expert review, among other things.
There are six new guidances on the way before the end of the year, Shuren told reporters after a town hall meeting in San Francisco this week.
The watchdog agency has been busy with new releases for the past several months as it aims to stay on top of the 25 action items listed in its Plan of Action for Implementation of 510(k) and Science Recommendations, launched earlier this year to improve the FDA’s review processes.
In the last week along, the agency unveiled plans to improve the science used to approve medical devices and outlined the details for an independent group of scientific experts to help the agency better understand emerging technologies.
Other recent releases include:
- Streamlining the de novo review process, draft guidance released last week
- Updates to postmarket surveillance, draft guidance released August 16
- Standards for clinical studies for PMA submissions, draft guidance released August 15
- The agency’s first guidance on the PMA benefit-risk determination process, draft guidance released August 15
- More stringent review for pacemaker programers, proposed rule released August 4
- Updated premarket review standards, notice released August 2
- Specific exemptions from premarket notification standards, draft guidance released July 8
- Redefining which types of device modifications require a new 510(k) application, draft guidance released July 26