- April 13, 2021
- 1:00 PM - 3:00 PM ET
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How to Use Consensus Standards in Premarket Submissions: The use of FDA-recognized consensus standards promotes predictability, advances regulatory science, and supports a least burdensome approach to medical device review. The first session of the CDRH Industry Basics Workshop will discuss how to use and reference standards in your device submissions.
The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions: The second session introduces the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, which is intended to improve the efficiency of conformity assessment in device review. This session will share strategies for successful participation in the ASCA Pilot.
Each session will feature a presentation followed by a moderated question and answer session with a panel of knowledgeable FDA staff. Audience participants will have the opportunity to send in questions to be answered during each session.
There is no fee to attend and registration is not required.
You may choose to participate in one or both sessions. Each session will begin at the scheduled time:
- 1:00-2:00 p.m. ET: How to Use Consensus Standards in Premarket Submissions
- 2:00-3:00 p.m. ET: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
Target Audience: All medical device industry, testing laboratories and accreditation bodies.
How to Join the Workshop:
On April 13, go to this page to join the workshop: CDRH Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
The CDRH Industry Basics Workshop is a general educational forum. Prior to the workshop we encourage you to review the Standards Modules in CDRH Learn.
For questions about this program, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices at firstname.lastname@example.org, or via phone at 1-800-638-2041, or 301-796-7100.