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In a significant policy shift, the FDA is going to reclassify some medical products as devices rather than drugs, in accordance with an April 16 ruling by the U.S. Court of Appeals for the District of Columbia Circuit, the agency said in an Aug. 9 Federal Register notice. Read More
An EU expert panel has challenged a notified body’s clinical evaluation report, which is an additional element of conformity assessment for certain high-risk devices under the EU’s Medical Device Regulation (MDR), marking the first such challenge. Read More
The EU’s Medical Device Coordination Group (MDCG) has issued new advice to devicemakers on how to integrate EU unique device identification (UDI) requirements into their quality management systems. Read More
The European Medicines Agency (EMA) has released guidance to devicemakers and notified bodies on how drug-device combination products should comply with the EU Medical Device Regulation (MDR) that went into effect on May 26. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
Nearly eight years after the FDA published its final rule on the unique device identification (UDI) system, it now has issued final guidance that describes the requirements for the form and content of the UDI system. Read More
The FDA’s Gastroenterology and Urology Devices Advisory Committee voted in support of FDA approval for Transmedics’ Organ Care System (OCS) in a July14 meeting. Read More
Italy’s Kiwa Cermet Italia SPA has become the 21st notified body to be certified under the EU Medical Device Regulation, which went into effect on May 26. Read More
Pfizer has agreed to a $345 million settlement of a class action antitrust suit over the EpiPen, an epinephrine auto-injector used in the emergency treatment of anaphylaxis. Read More
Australia’s Therapeutic Goods Administration (TGA) is making changes to its procedures for announcing devices suspended from the Australian Register of Therapeutic Goods. Read More