The Accreditation Scheme for Conformity Assessment (ASCA) Program enables manufacturers of FDAregulated medical devices to leverage ASCA Summary Test Reports from ASCA-accredited testing laboratories in demonstrating conformity with FDA-recognized consensus standards. The Program enhances confidence in qualified testing laboratories, mitigates risk, and
streamlines premarket review of test reports.
Objectives
Program offerings will:
- 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
ASCA Engagement Opportunities
The ASCA Team is available to present:
- Virtually or in-person
- Domestically and internationally (subject to location, lead time, and presenter availability)
- As independent presenters or as contribution speakers at larger events/meetings
Including
UL Solutions Perspective: Leveraging FDA ASCA Accreditation
Explore how ASCA-accredited laboratories support confidence in testing outcomes, improve regulatory efficiency, and help manufacturers maximize the value of test data across global market access and certification pathways.
Agenda
Event Timeline (CST):
- 5:30 PM – 6:00 PM registrant arrival, food, and networking
- 6:00 PM – 7:15 PM presentations
- 7:15 PM – 7:45 PM questions and answers
- 7:45 PM – 8:15 PM networking and wrap up
Location
UL Solutions Headquarters
333 Pfingsten Road
Northbrook, IL 60062
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
Jennifer Coble
Pamela Gwynn
