Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement

Part two of a six-part webinar series.

Under the FDA’s regulation, laboratories with LDTs must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in the series, Understand and Prepare for the Impact of the FDA’s LDT Final Rule, discussed existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. 

Speakers

• Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
• Earle S. Collum, MD, FCAP, chair, Council on Accreditation