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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 Draft guidance was issued on collection of race and ethnicity data in clinical trials.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
The FDA aims to reduce the regulatory burden by “streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.” Read More
Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? 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
AdvaMed has urged Congress to pass the Tax Relief for American Families and Workers Act of 2024 (H.R.7024) that contains a tax change that would allow businesses to deduct their research and development expenses in one year instead of over five years. 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