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Ideal Implant received a warning letter from the FDA for quality system deficiencies including failure to document complaint investigations and medical device reportability for complaints related to its saline-filled breast implants. Read More
Allergan failed to comply with post-approval study requirements for its Natrelle silicone-filled breast implants, the FDA said in a warning letter to the Irvine, California-based company. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance on the 3D printing of medical devices during the COVID-19 pandemic. Read More
Former FDA Chief Scientist Jesse Goodman told a House subcommittee hearing that the FDA’s decision to allow diagnostic test developers to self-validate their COVID-19 products caused a flood of unqualified products on the market. Read More
As part of a postmarket review, Australia’s Therapeutic Goods Administration (TGA) is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies. Read More
Following four deaths, Medtronic recalled its HeartWare pump outflow graft and outflow graft strain relief because the outflow graft of the HeartWare ventricular assist device (HVAD) pump may tear, and the strain relief screw may break during assembly. Read More
Failure to establish and maintain design validations and proper risk management procedures for its Swaive thermometer landed Taiwan’s E-Care Technology a warning letter From the FDA for inadequate responses to a 483 the firm received following an inspection of its Chubei City facility. Read More
Devicemaker Lymol Medical FDA received a warning letter from the FDA for failure to validate cleaning and sterilization processes, among other GMP failures, uncovered during an inspection of its Woburn, Massachusetts facility. Read More