FDA's Accreditation Scheme for Conformity Assessment (ASCA) Program is a voluntary program that enables medical device manufacturers to demonstrate conformity to selected FDA-recognized consensus standards through testing performed by FDA-recognized, ASCA-accredited laboratories. The program covers areas such as electrical safety and biocompatibility and enhances confidence in test results submitted to support medical device premarket submissions. Dr. Simon Choi from FDA will provide an overview of the ASCA Program, discuss recent developments, and explain how manufacturers can leverage the program as part of their regulatory strategy.
- Provide an overview of the CDRH Division of Standards and Conformity Assessment (DSCA)
- Cover the fundamentals of the ASCA Program • Discuss ASCA case studies and data demonstrating premarket benefits
- Explore best practices for interacting with testing laboratories
- Address data integrity in conformity assessment
- Share Program updates
- Invite stakeholder feedback on potential program improvements
RAPS Wisconsin is grateful to Findhorff and the University of Wisconsin – Madison Capstone Certificate in Quality Assurance and Regulatory Affairs program for their support of this event.
Location
Findhorff Madison Office
300 South Bedford Street
Madison, WI 53703
Cancellations and Refunds
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. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
