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Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient care, according to an agency advisory committee. Read More
Percussionaire’s recall of High-Frequency Transport Phasitron Breathing Circuit kits has been identified as a Class I recall by FDA due to a product defect that causes over-pressurization. Read More
Philips North America’s recall of its Brightview gamma camera system, used in nuclear medicine, has been deemed Class I by the FDA, for the potential of the camera falling on the patient. Read More
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