Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
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FDA Recalls More COVID-19 Tests
Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test the latest in string of recent Class I events.
Recent Recall a Reminder to Check Which COVID-19 Tests Your Lab Can Use
Celltrion’s recall was labeled by the FDA as Class I, due to the kits possibly being distributed to non-CLIA certified users.
FDA Reorganizes Its Center for Devices and Radiological Health
The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health.
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.