New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
Already a member? Log in here
Be ‘Recall Ready,’ FDA Urges Companies
SILVER SPRING, MD — On March 3, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary,...
Monitoring Tech Dominates Recent Breakthrough Device Designations
In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include...
Harmonizing Device CGMP Requirements with International Standards
...
Already a member? Log in here
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
Already a member? Log in here