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Inadequate procedures related to medical device reporting and other serious quality issues were uncovered during an April 6-16, 2021 inspection of Forcemech International’s Pearland, Texas facility. 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
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 Acting Commissioner Janet Woodcock has called for expanded authority to improve the agency’s ability to prevent medical device shortages. Read More
FDA investigators observed a variety of good manufacturing practice deficiencies during four inspections conducted this spring at facilities in New York, California and North Carolina. 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 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 came into effect on May 26. 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