FDA Law

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA recommends including only a limited number of modifications in the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026. 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

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. Here’s a brief overview of the key pieces of legislation that AAFP is diligently monitoring.

Insurance 130

Insurance Management Hospital Vaccination 130