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The EU’s Medical Device Coordination Group (MDCG) released guidance on evaluating the performance of in vitro diagnostics that detect SARS-CoV-2 nucleic acid, antigens and that quantify antibodies. Read More
Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More
Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey. Read More
The FDA issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. Read More
The FDA expects to collect almost $263 million in user fees from devicemakers in fiscal year 2022 and it is increasing registration and application fees across the board. Read More
The FDA has accredited 68 testing laboratories so far under its Accreditation Scheme for Conformity Assessment (ASCA) pilot, in which testing labs may be accredited by accreditation bodies to assess the conformance of a device with certain FDA-recognized standards. Read More
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