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Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More
Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Read More
The FDA has revoked the emergency use authorization (EUA) for protective barrier enclosures used by healthcare providers when caring for patients thought to be infected with COVID-19 to prevent exposure by providing an extra layer of protection in addition to personal protective equipment. Read More
The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Read More
The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19. Read More