FALLS CHURCH, Va. (PRWEB) May 05, 2021
Ready to take advantage of the FDA’s Center for Devices and Radiological Health‘s (CDRH) new Accreditation Scheme for Conformity Assessment (ASCA) pilot program?
There are definite benefits to devicemakers when they participate — ASCA allows accredited testing laboratories to assess the conformance of a device with FDA-recognized standards.
After all, it was the FDA’s goal when it launched the pilot in September 2020 to increase the consistency and predictability with which testing will meet recognized standards.
In this webinar, 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 an overview of the ASCA pilot, show attendees how to conform to it and use it to their advantage, explaining:
- 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.
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
CDRH’s New Accreditation Scheme for Conformity Assessment:
Impacts on Your Future Testing Plans and FDA Submissions
An FDAnews Webinar
Wednesday, May 19, 2021, 1:30 p.m.-3:00 p.m. EDT
$287 per site
Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations