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.

Webinar Takeaways:

  • 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