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Medical Devices

Alert on Passive Protective Barrier Enclosures

FDA alerts health care providers that the use of passive protective barrier enclosures when treating Covid-19 patients may pose an increased health ri...

Human Drugs

FDA Warns CBD Web Site Over Covid-19 Claims

FDA cites Living Senior, Las Vegas, NV, over its www.blueribbonhemp.com Web site that markets CBD products for treating Covid-19 patients.

Federal Register

Device Panel to Review TransMedics Donor Heart Care System

Federal Register notice: FDA announces a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel, which will discuss ...

Human Drugs

Bayshore Recalls 2 Lots of Metformin

Bayshore Pharmaceuticals recall two lots of metformin hydrochloride extended-release tablets due to the detection of N-nitrosodimethylamine levels abo...

Federal Register

Info Collection Extension on Focus Groups

Federal Register notice: FDA sends to OMB an information collection extension on Focus Groups as Used by the Food and Drug Administration (All FDA-Reg...

Federal Register

Outsourcing Facility Registration Information Collection

Federal Register notice: FDA seeks comments on a revised information collection on Registration of Human Drug Compounding Outsourcing Facilities and A...

Federal Register

Info Collection on Device Corrections and Removals

Federal Register notice: FDA sends to OMB an information collection on medical device corrections and removals reporting.

Medical Devices

Trump Lifts Lab Tests from Need to Get OK from FDA

A new Trump Administration initiative exempts laboratory-developed tests, including those for Covid-19, from the need to get FDA premarket review.

Hahn Reassures Public in TV Appearance

FDA commissioner Stephen Hahn tells a Michigan TV station that the agency is not under any political pressure to speed approval of a Covid-19 vaccine....

Medical Devices

FDA Multifunctional Device Guidance Explained

Ropes & Gray attorneys outline key provisions in an FDA final guidance on multiple function medical devices.