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Medical Devices

Pelvital Flyte Urinary Incontinence Therapy Cleared

FDA cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles to help women with st...

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....