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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
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. 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
Over the past week, the FDA issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation. Final guidances were issued on chimeric antigen receptor T cell (CAR T) products, human gene therapy products and individual patient expanded access applications. Draft guidance was issued on collection of race and ethnicity data in clinical trials. 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