FDA's Center for Devices and Radiological Health (CDRH) will host a free "industry basics workshop" April 13 on two topics related to the CDRH Standards and Conformity Assessment Program. At 1 p.m. there will be a one-hour session covering how to use FDA-recognized concensus standards in premarket submissions. At 2 p.m. there will be a one-hour session that will introduce the Accreditation Scheme for Conformity Assessment (ASCA) pilot, which is intended to improve the efficiency of conformity assessment in device review, and 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 FDA staff. Participants will have the opportunity to send questions during each session. The workshop sessions are free and registration is not required.
To join the workshop, go to this page on April 13: CDRH Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Those interested in attending are encouraged to review the Standards Modules in CDRH Learn prior to the workshop. If you have questions about the workshop, contact the Division of Industry and Consumer Education.