FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

Physician's Weekly

JUNE 26, 2025

In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Once a rock climber, she became a couch potato. Kennedy Jr. forced him out in May. The current U.S.

Vaccination 52

Vaccination Patient-Centered Government IT 52