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Although counterfeit devices may meet the definition of a “device,” the FDA will not be treating them as such, the agency says in a final guidance released yesterday. Read More
The FDA’s Ophthalmic Devices Panel met Thursday and reached consensus that unfilled/empty eye cup and “droptainer” ophthalmic devices — currently unclassified — should be considered Class I with general controls, as recommended by the FDA. Read More
The FDA has granted Breakthrough Device designations for Avita Medical’s Recell System for soft tissue repair and vitiligo – a condition in which the skin loses its pigment. Read More
Allotrope Medical has received the FDA’s Safer Technologies Program (STeP) designation for its StimSite surgical device, which helps surgeons locate and identify the ureter during abdominal surgery, reducing post-surgery cystoscopy time. Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance on requirements created by the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) for devicemakers’ “authorized representatives,” including who, when and how to register. Read More
The average total review time declined from 170 calendar days in 2018 to 126 in 2022, but there was a pandemic-related spike to 190 days in 2020. Read More
The Center for Devices and Radiological Health (CDRH) is encouraging research on the use of digital health technologies (DHT) to advance patient engagement, leverage connectivity and improve healthcare, according to a report the center released last week. Read More
Representatives from Medtronic and Masimo, both manufacturers of pulse oximeters for more than three decades, defended the accuracy of their devices for patients of all skin tones at an FDA advisory panel meeting yesterday. Read More