We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
The Center for Devices and Radiological Health (CDRH) gives devicemakers concrete examples of real-world evidence (RWE) used in premarket and postmarket submissions in a newly released report. Read More
The FDA issued an alert about thermal imaging systems intended to measure human body temperature because improper use of these systems may provide inaccurate temperature readings. Read More
A panel of the FDA’s Medical Devices Advisory Committee will meet virtually on April 6 to consider a premarket approval application for the TransMedics Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation of donor hearts intended for a transplant recipient. Read More
Australia’s Therapeutic Goods Administration is seeking industry input on whether it should adopt the EU Medical Device Regulation on nanomaterials in medical devices. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that paclitaxel drug-coated balloons or drug-eluting stents should not be used in the routine treatment of patients with widening of the arteries, as the mortality risk generally outweighs the benefits. Read More
The FDA is warning devicemakers that have been touting phony FDA registration certificates that give the false impression that their products have been cleared by the agency. Read More
The FDA appears to be putting on the brakes to many requests for emergency use authorization (EUAs) for COVID-19 diagnostic tests, and industry experts say the FDA could be doing more to inform industry. Read More