FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

FDA Law

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 64

Manufacturing Provider Physicals Electronics 64