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Failure to implement procedures for corrective and preventive actions (CAPAs) and to ensure the accuracy of test/measurement equipment coupled with missing documentation for device history records landed Northwest Eye Design a 483 following an inspection of its Kirkland, Washington facility. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations. Read More
Centurion Medical Products received an FDA warning letter for selling unapproved combination test kits following FDA inspections at the firm’s Howell, Michigan facility Aug. 5-20, 2019, and its Williamston, Michigan facility Oct. 21 to Nov. 1, 2019. Read More
The FDA issued a warning letter to Modern Allergy Management doing business as Direct Med Solutions in Milton, Florida for selling COVID-19 test kits for at-home use. The test kits are considered adulterated and misbranded products, the agency said. Read More
The FDA clarified its regulatory approach for multiple function devices in a final guidance that outlines the extra steps manufacturers of such products need to take. Read More
An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led to calls for major reforms at the agency due to its mishandling of safety concerns linked to pelvic mesh. Read More
The Biomedical Advanced Research and Development Authority (BARDA) has partnered with digital medicine company Sonica Health to develop a clinical-grade patch for detecting COVID-19. Read More
Missing design control procedures for Nexalin Technology’s transcranial electrotherapy stimulator landed the firm a Form 483 following an inspection of its Houston, Texas facility. Read More