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.
Evaluating the accuracy of pulse oximeter readings on individuals with differing skin pigmentation, and differentiating between the device’s medical vs. OTC versions dominated the discussions during Friday’s FDA advisory committee meeting. Read More
According to the FDA, between 2011 and April 2021, Philips submitted 30 MDRs that the company identified as associated with the PE-PUR foam breakdown. Read More
CDRH plans to reclassify most in vitro diagnostic tests (IVD) from class III (high risk) to class II (moderate risk), enabling manufacturers to seek marketing clearance through the premarket notification (510(k) pathway than the more stringent premarket approval pathway. Read More
The FDA aims to reduce the regulatory burden by “streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.” Read More
The FDA will have to exponentially ramp up its hiring to properly understand and regulate quickly developing AI and the many ways it’s poised to change development of drugs and devices, said FDA Commissioner Robert Califf. Read More
The FDA has released its long-awaited Quality Management System Regulation (QMSR) final rule, including a change that requires medical device manufacturers to be compliant within two years instead of the originally proposed one year. Read More
The CDRH Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office, effective immediately, a designation that the FDA says will allow OST to adapt to and address future public health needs and challenges. Read More
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. Read More