Webcast | Virtual
Event Title
Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements
August 22, 2024
- Date:
- August 22, 2024
- Time:
- 1:00 PM - 2:30 PM ET
Summary
On May 6, 2024, the FDA issued a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs.
On August 22, 2024, the U.S. Food and Drug Administration (FDA) held a webinar for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy).
Webinar Materials
The presentation, printable slides, and transcript are available on CDRH Learn under "In Vitro Diagnostics."
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.