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The agency noted that roughly 88 percent of customer complaints were related to the bed’s adjustable base, but the firm failed to request a corrective action by the supplier. Read More
Numerous bugs were reported related to IT Synergistics’ LifeTec Elite version 1 and 2 blood establishment computer software but were not documented as complaints and weren’t investigated, according to a 483 the firm received following a March 5-6, and June 23 FDA inspection of its Flowood, Mississippi facility. Read More
Failure to submit a field report to the FDA, and failure to submit medical device reports were just two of the 13 quality lapses that dogged specification developer Craftmatic Industries found during an FDA inspection at its Pompano Beach, Florida facility. Read More
A study assessing the FDA’s De Novo premarket review pathway found that some devices received clearance without supporting data from pivotal clinical trials. Read More
The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic. Read More
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. Read More
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Read More
Of the devices that did go through pivotal trials, 31 percent failed to meet at least one primary efficacy endpoint, but the devices still earned clearance, the researchers found. Read More
The implant combines the benefits of collagen with the structural integrity required for “demanding tendon and ligament applications from foot and ankle to complex shoulder repair procedures,” said Kevin Bonner, a member of Embody’s advisory board. Read More