FDA Releases Draft Guidance on the PMA (written by Laura Uzdienzski @ HealthPointCapital)
Furthering its efforts at transparency in its regulatory processes, the FDA released new draft guidance on Monday regarding clinical study expectations for medical devices.
According to data from 2008-2010, the FDA has struggled to meet its MDUFA objectives of reviewing PMA applications within 180 days. During that two-year period, only 37 of 85 submissions, or 56%, were reviewed within the 180-day timeframe. The new guidance may help to accelerate that time horizon or minimize the back-an...
