UNDATED – On Tuesday, April 13, 2021, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will host an Industry Basics Workshop on two topics related to the CDRH Standards and Conformity Assessment Program:
- 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 Industry Basics Workshop will discuss how to use and reference standards in your device submissions.
- The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
This 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.
This Industry Basics Workshop will address each topic in separate one-hour sessions. Each session will feature a presentation followed by a moderated question and answer session with a panel of knowledgeable FDA staff. Participants will have the opportunity to send questions during each session.
There is no fee, and registration is not required.
Date: Tuesday, April 13, 2021
Time: 1:00-3:00 p.m. Eastern Time (ET)
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
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.
If you have questions about the Industry Basics Workshop, contact the Division of Industry and Consumer Education.