US Market Access for Medical Devices: FDA and ASCA Program 2024

The U.S. Food and Drug Administration (FDA) voluntary Accreditation Scheme for Conformity Assessment (ASCA) 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 has multiple FDA ASCA-accredited testing laboratories located in the United States, Europe and Asia.

Join UL Solutions’ and FDA’s experts to gain insights into:

• The FDA’s role in the U.S. and classification of medical devices.
• The approval processes: 510(k) and Premarket Approval (PMA).
• The ASCA program: goals, steps, deliverables and 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 the 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, PhD, ASCA testing laboratory lead, basic safety and essential performance, FDA