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American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More
Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
Vietnam’s Ministry of Health has issued a decree specifying requirements for the manufacture, sale, services, information and advertising of medical devices. Read More
Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. Read More
FDA Chief Scientist Jesse Goodman is leaving the agency for Georgetown University and the D.C. Veterans Administration Hospital, where he will teach and practice medicine. Read More
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More
Veterans Affairs medical centers should identify additional implants for coverage by VA-negotiated national committed-use contracts and set a timeline for expanding the volume of implants covered by these contracts, the General Accountability Office recommends in a new report. Read More