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 FDA has updated Medtronic’s November 2022 recall of its Mahurkar Acute Dual Lumen High Flow (13.5 French) hemodialysis catheters to Class I, due to a potential catheter hub defect that could cause the catheter tubes to leak, possibly leading to serious injury or death.
The FDA is planning to survey medical devicemakers and other “key stakeholders” to identify barriers that prevent developers from entering the pediatric device market as well as “incentives that would motivate them to innovate and sustain within this market.”
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture, but measuring the maturity of that culture takes more than just looking at metrics, according to several experts in a recent FDAnews webinar.
Gastrointestinal diagnostic test developer Geneoscopy has submitted a premarket approval (PMA) application to the FDA for its ColonoSight, a stool-based at-home noninvasive screening test that detects colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.
The FDA has invited devicemakers to apply for funding to develop medical devices for children through the FDA’s Pediatric Device Consortia grants program.