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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
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
FDA investigators observed a variety of good manufacturing practice deficiencies during inspections this spring at facilities in California, Minnesota, New York, North Carolina and Texas. 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
Australia’s Therapeutic Goods Administration is proposing to ease certain requirements in its regulatory framework for custom-made and 3D-printed devices that became effective in February. Read More
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More
Groups that will be impacted by the EU’s In Vitro Diagnostic Regulation (IVDR) are calling for urgent action to further delay its May 26, 2022 effective date and for a phased implementation. Read More