2026, Manufacturing and Physicals

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

2026

Manufacturing

Physicals

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

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. issues with the design, manufacturing, and components of the device).

Manufacturing

Manufacturing Electronics Provider Management

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

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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

Stay Connected