In September 2020 the FDA’s Center for Devices and Radiological Health (CDRH) launched its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the conformance of a device with FDA-recognized standards. Devicemakers can use testing by an ASCA-accredited laboratory to support premarket submission for any device, including device submissions for combination products
There are benefits in the pilot program — ensuring device performance and expediting the review of marketing applications — but you must know how to proceed.
Two members of King & Spalding’s FDA and Life Sciences practice — Elaine Tseng, a partner, and Quynh Hoang, a senior regulatory consultant and 24-year veteran of CDRH — will give you an overview of the ASCA pilot, show you how to conform to it and use it to your advantage.
- Who may participate in the ASCA pilot
- Pros and cons of participating
- What participants can expect
- Implications of the ASCA pilot moving forward
- What information is made available on pilot participants
Understand the potential impact of the ASCA on your testing plans.
Who Will Benefit:
Device Manufacturers’ Management, Regulatory and Quality System (Testing) Staff
Management of Accreditation Entities
Management of Independent Testing Facilities