CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions – Webinar Recording/Transcript
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. Join us by registering today.
Meet Your Presenters
Elaine Tseng, a partner in King & Spalding’s nationally recognized FDA and Life Sciences practice, has more than 20 years of experience representing life sciences companies on FDA legal and regulatory matters. She has worked extensively with medical device developers on regulatory strategy, approval, marketing and compliance issues, including expediting pathways to market.
Quynh Hoang is a senior regulatory consultant in the FDA and Life Sciences practice at King & Spalding. She specializes in FDA’s premarket processes for medical devices and combination products with a device constituent part (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD and Reclassification Petition), as well as in the FDA’s postmarket process for adverse signals. Prior to King & Spalding, Ms. Hoang spent 24 years at FDA/CDRH and accumulated extensive experience in the premarket review of medical devices.
Who Will Benefit
- Device Manufacturers’ Management, Regulatory and Quality System (Testing) Staff
- Management of Accreditation Entities
- Management of Independent Testing Facilities
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May 19, 2021