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Oct 6, 2022
  • Webinar

US Market Access for Medical Devices: FDA and ASCA Program

The U.S. Food and Drug Administration voluntary ASCA Pilot program is designed to improve the premarket review process. Join UL Solutions and FDA experts to gain insights into its goals and benefits.

High-tech medical devices in an operating room

Date & Time

Starts

Oct 6, 2022 2:00pm CEST

Ends

3:30pm CEST

Location

Online

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, an FDA ASCA-accredited testing laboratory, possesses multiple testing locations in Europe and worldwide.

Join the FDA’s experts and our talent 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

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

Speakers

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