2026 IT Manufacturing Medical 
FDA Law Blog
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.
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. By Steven J. Gonzalez & Lisa M.
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FDA Law Blog
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.
FDA Law Blog
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 – Applications open, Q4 of FY 2023.
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. §
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. SB 58 & 101 – Age of Medical Consent Bill What’s in the Bill: Sponsored by Sen.
FDA Law Blog
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. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH.
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