2026, Electronics, Patients and Physicals

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2026

Electronics

Patients

Physicals

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law

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. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing

Manufacturing Electronics Provider Management

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

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. MDRs must be reported to FDA in electronic format. report certain device malfunctions, and.

Manufacturing

Manufacturing Provider Physicals Electronics

Primary Care Digest

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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