FDA To Ramp Up ASCA Pilot In 2021
Executive Summary
A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.
You may also be interested in...
FDA’s 5 Steps To A Successful ASCA Pilot Submission
Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.
Consensus Standards, ASCA Pilot Are Subjects Of Back-To-Back ‘Industry Basics’ Workshops By FDA
The US FDA will explain how device makers can use standards in premarket submissions and focus on the benefits of the agency’s Accreditation Scheme for Conformity Assessment (ASCA) Pilot in two hourlong workshops on 13 April.
Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.