NOVEMBER 12, 11:00 AM ET
The FDA’s device regulations include detailed quality system requirements, which are being amended to align with ISO 13485. FDA will begin enforcing the new requirements, known as the Quality Management System Requirements (QMSR), in February 2026.
Under the final rule regulating laboratory developed tests (LDTs) as devices, laboratories are required to comply with quality system requirements by May 6, 2027. If the final rule remains in effect, labs will have to develop and implement QMSR-compliant processes, procedures, and systems. Even if the final rule is vacated, invalidated, or rescinded by judicial, legislative, or administrative action, new legislation will likely provide the FDA with some form of jurisdiction over LDTs.
Any regulation by the FDA will include a quality system, and the agency is likely to apply the QMSR. This webinar will provide an overview of the new QMSR requirements and explain what steps labs need to take to be ready to comply.
Speaker:
Christine P. Bump
Principal and Founder
Penn Avenue Law & Policy
Note: You only need to register once to be signed up for all of the November 2024 Lab Institute talks. View the full event agenda at https://www.g2intelligence.com/lab-institute-virtual-event-advancing-the-profession-of-diagnostic-medicine-2024/.