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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
An FDA inspection of Smiths Medical’s Minneapolis facility revealed validation lapses, complaint handling procedures that weren’t handled correctly and inadequate corrective and preventive action (CAPA) procedures. Read More
Quality audits were not being performed at sufficient intervals, and management with executive responsibility had not reviewed the effectiveness of the quality system at defined intervals, the FDA said following an inspection of MedHab’s Arlington, Texas plant. Read More
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