United States | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- US FDA has launched a pilot program for streamlined 510(k) reviews using its eSubmitter software.
- Eligible premarket notification applicants are not required to submit paper copies of their premarket applications to FDA.
- FDA has set 60-day review timeframes for 510(k) applications submitted through the program, versus 90 days for standard 510(k) application routes.
The US Food and Drug Administration announced a new pilot program allowing qualified 510(k) medical device registrants to submit only...
Source | Stewart Eisenhart
Sep 10, 2018