San Francisco Bay Area Chapter: ASCA: A New Pilot Program from the FDA

When:  Nov 5, 2019 from 9:30 AM to 12:30 PM (ET)

*Students:  $20
RAPS Members:  $35
Nonmembers: $50 

*Fax/email in a completed registration form to get the student rate. 

FDA’s Center for Device and Radiological Health’s Standards and Conformity Assessment Program is committed to the advancement of regulatory science in support of medical device review. Capitalizing upon the increasingly prominent role that standards play in promoting public health and efficient regulatory practices, CDRH is implementing a pilot conformity assessment initiative, entitled the Accreditation Scheme for Conformity Assessment, or ASCA.

This voluntary program, authorized by the Medical Device User Fee Amendments of 2017 (MDUFA IV) to the Federal Food, Drug & Cosmetic (FD&C) Act, is designed to increase consistency and predictability in the FDA’s approach to assessing conformance with ASCA-eligible standards in medical device premarket reviews. The ASCA Pilot is intended to reduce regulatory burden by enhancing product reviewers' confidence in medical device testing, which should decrease the need for internal FDA consultations, complete test report reviews and additional information requests. Ultimately, the ASCA Pilot is intended to allow FDA to ensure safe, effective, and high-quality medical devices are available to patients without avoidable delay.

Don’t miss this unique opportunity to learn more about this pilot program and to share your comments directly with FDA representatives.

This event, hosted by our partner UCSC Silicon Valley Extension, is brought to you by the RAPS San Francisco Bay Area chapter and is intended to encourage more open communication between device manufactures and regulators. Breakfast will be provided for all attendees and RAC holders may claim two RAC recertification credits.

Featured FDA Speaker: Gail M. Rodriguez, PhD, senior policy advisor, Standards and Conformity Assessment (S-CAP), CDRH, FDA



3175 Bowers Ave
Rooms 2130/2150
Santa Clara, CA 95054-3225