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FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

Visible Vapors LLC, based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids, received a warning letter from the FDA advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

AnchorDx’s Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns “Breakthrough Device Designation” from FDA

Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine.

FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System

"The Breakthrough Device designation for our TransAeris temporary diaphragm stimulation system is built upon our 20-year experience with NeuRx diaphragm pacing," said Anthony Ignagni, President & CEO of Synapse Biomedical.

Coronavirus (COVID-19) Update: June 22, 2021

FDA issued a Drug Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger. FDA

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for this indication.

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

Medtronic's decision to stop the sale and distribution of the HVAD follows the company's voluntary recall of a subset of the HVAD pumps in December 2020. The FDA will continue to monitor adverse events associated with the HVAD System and keep health care providers and the public informed as new or additional information becomes available.

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

The Cognoa ASD Diagnosis Aid is a software as a medical device that uses a machine learning algorithm to receive input from parents or caregivers, video analysts and health care providers to assist physicians evaluate a patient at risk of ASD.