RAPS Members: $35
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 is brought to you by the RAPS Chicago chapter and is intended to encourage more open communication between device manufactures and regulators. Dinner will be provided for all attendees and RAC holders may claim two RAC recertification credits.
Featured FDA Speaker: Simon Choi, PhD, MPH, senior policy analyst, Standards and Conformity Assessment Program, CDRH, FDA
Local contact: Joseph Orlowski, RAC, RAPS Chicago Chapter
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at firstname.lastname@example.org.