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.

Find out more and register.