FDA Law

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. By Adrienne R.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Schedule IV substances are highly addictive and rarely used in medical practice while schedule I substances are also highly addictive, liable to abuse or convertible to drugs similarly addictive and liable to abuse. Whether DEA believes the U.S.

Manufacturing 59

Manufacturing Consulting IT Individual 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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Notable Dates and Timelines – New MAPP published, by Dec.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

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. § 820.198).

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45