Utah Chapter Webcast: FDA’s ASCA Pilot: Streamlining Conformity Assessment in Device Submissions

2.0
RAC Credits
Thursday, 03 June 2021 (8:00 AM) - Thursday, 03 June 2021 (10:00 AM) Mountain Time (US & Canada)

Member: $10
Nonmember: $25

Description

Join the RAPS Utah Chapter for an update on FDA’s Accreditation Scheme for Conformity Assessment Pilot, or ASCA, which establishes a voluntary accreditation program for testing laboratories. Test results from ASCA-accredited test labs should enhance confidence in medical device testing and streamline FDA’s approach to conformity assessment in premarket review. 

During this session, Dr. Eric Franca, the ASCA Test Lab Lead for basic safety and essential performance, will share progress with the Pilot and provide practical direction on how to compile a submission with ASCA testing. 

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by the RAPS Utah Chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: Intermediate
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Dr. Eric Franca, ASCA Test Lab Lead, Biomedical Engineer, and Senior Policy Advisor, FDA

Thank you to our Platinum Chapter Sponsors: