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.
Once a complaint is deemed potentially reportable as a medical device report (MDR), a designated individual within the complaint handling unit must promptly begin an investigation. Read More
Members of Congress from both parties have asked the Centers for Medicare and Medicaid Services (CMS) to take action to deal with “preventable error” leading to false-positive results from blood tests used in the diagnosis of sepsis. Read More
The FDA’s proposed rule on over-the-counter (OTC) hearing aids does not introduce a new device classification, but is more “like a rule of the road,” explained Ian Ostermiller, policy adviser in the FDA’s Office of Policy, during a Tuesday webinar hosted by the agency. Read More
Becton Dickinson (BD) is spinning off its diabetes care business under the name “embecta,” the Franklin Lakes, N.J.-based device giant announced yesterday. Read More
Louisville, Ky.-based devicemaker Induction Therapies has been marketing a microneedling product without FDA approval, the agency said in a warning letter to the company. Read More
The ultimate goal of verification and validation testing is to show that there is a minimal risk that a device will not perform as intended. To prove this to the FDA’s statistical satisfaction, companies must select sample sizes that will accurately reflect the real risk. Read More
Device manufacturing facility workers are routinely exposed to biohazards when they reprocess devices for reuse, even when they are wearing personal protective equipment, researchers have found. Read More