Watch now: US market access for medical devices: FDA and ASCA program
Watch this on-demand webinar to gain insights into:
- FDA’s role in the U.S. and classification of medical devices.
- The approval processes: 510(k) and PMA.
- ASCA program: goals, steps and deliverables, benefits.
- How to combine ASCA with other certification processes.
Oct. 6, 2022
Pamela Gwynn, principal development engineer, UL Solutions
Eric Franca, Ph.D., ASCA testing lab lead - basic safety and essential performance
Angela DeMarco, M.S., 510(k) program expert
Gain insights on ASCA from UL Solutions and FDA experts
The U.S. Food and Drug Administration (FDA) voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot program is designed to improve the premarket review process. It was created to increase FDA product reviewers’ and device manufacturers’ confidence in medical device testing when performed by an ASCA-accredited laboratory and should help reduce the need for additional information during the premarket review process. UL Solutions is an FDA ASCA-accredited testing laboratory with multiple testing locations in Europe and worldwide.
Thanks to this webinar, attendees will be able to understand how working with UL Solutions on ASCA program can help:
- Reduce the number of FDA additional information requests related to testing and the need for repeat or revised testing.
- Provide flexibility and consistency in the premarket review process, ranging from a single test to certifications depending on your needs.
- Assist medical device manufacturers in meeting the FDA's regulatory requirements.