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.
A new FDA report shows medical device recalls nearly doubled from fiscal year 2003 to 2013, but a greater focus on safety — not shoddier products — appears to be behind the rise. Read More
HHS’ health IT coordinator is calling for all electronic health records to incorporate the unique device identifiers of implantable devices by 2015. Read More
The U.S. could save about $30 billion in healthcare costs a year by requiring medical devices to be interoperable, a white paper by West Health Institute and the Office of the National Coordinator for Health IT concludes. Read More
CDRH will now publish a Federal Register notice and post “Immediately in Effect” guidance on its website when it changes its scientific expectations for a product under development, according to a final standard operating procedure that took effect Wednesday. Read More
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend. Read More
A new UK proposal would allow the country’s healthcare administration to consider “burden of illness” as a measurable component when assessing new medical products for government reimbursement. Read More
The FDA is proposing to establish five categories of Class III devices, delineated by risks, benefits and available controls — a move that could help to streamline classification of high-risk devices and promote consistent expectations about the process. Read More