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While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues to rankle medical device makers looking to protect their intellectual property rights and the safety of FDA-regulated medical devices. Read More
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of FDA’s Office ofPolicy, Legislation, and International Affairs. Read More
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