FDA Announces Workshop on Expanding Medical Device Testing Program

FDA

WASHINGTON, D.C. — The Food and Drug Administration (FDA) will host a public workshop on November 6, 2024, to discuss expanding the Accreditation Scheme for Conformity Assessment (ASCA) Program. This event will focus on incorporating chemical analysis to support the biocompatibility of medical devices.

The workshop, held at the FDA’s White Oak campus in Silver Spring, Md., will also be webcast for remote attendees in a listen-only mode. Registration for in-person and virtual participation is open until October 30, 2024.

The FDA aims to engage with testing laboratories, device manufacturers, trade associations, accreditation bodies, and the general public. The discussion will center on stakeholders’ experiences with analytical chemistry testing for medical devices’ toxicological risk assessments. The goal is to explore standardized approaches to chemical analysis, such as those outlined in ISO 10993-18, which deals with the biological evaluation of medical device materials within a risk management process.

The workshop will run from 8:00 a.m. to 5:00 p.m. (ET). Due to limited in-person attendance, early registration is recommended. Participants will receive confirmation of their registration status, and onsite registration will be available if space permits.

For special accommodations or additional information, contact Susan Monahan at the FDA’s Center for Devices and Radiological Health (CDRHpublicmeetings@fda.hhs.gov). The FDA encourages those interested in the future of medical device testing to participate and share their insights.

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