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FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More
Medical devicemakers soon could have a new way to measure quality, thanks to a program created jointly by the FDA and Xavier Health and recently adopted by the Medical Device Innovation Consortium. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year. Read More
Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers. Read More
The FDA has warned AG Industries on medical device reporting failures related to a complaint of a mini-nebulizer shocking a child and other good manufacturing practice violations. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
The U.S. FDA has extended until Oct. 24 the deadline to submit required labeling and data to the Global Unique Device Identification Database following the discovery of a security vulnerability. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year.
Read More
FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More