CDRH Says Major Deficiency Letters Now at 81% of PMAs
Information prepared by FDA for the 3/6 MDUFA 3 quarterly performance meeting shows that the percentage of PMA originals and panel track supplements with major deficiency letters in the first FDA review cycle was 81%, as high as it was in 2010 and 2007. The meeting agenda covered guidances issued in the 1st quarter, FDA MDUFA performance actions through 12/31/16, qualitative update on finances, CDRH registration and listing, and a CDRH training update.
The briefing materials show that 14 medical device guidances were issued in the first quarter of FY 2017 (10/1/16 to 12/31/16). They also indicate that the total average time to MDUFA decision on PMA originals and panel track supplements was estimated at 274 days, one of the lowest average times since 2000.
Some 93% of PMA originals and panel track supplements were approved by CDRH in the 1st quarter of FY 2017, the same percentage as in all of FY 2016.