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The FDA issued an Emergency Use Authorization (EUA) for Lucira Health’s rapid coronavirus test, the first one authorized for self-testing at home and priced at an affordable $50. Read More
When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Read More
Medical Device Single Audit Program (MDSAP) activities have continued during the COVID-19 pandemic, forcing auditors and device manufacturers to adapt to a virtual environment. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Read More
As part of its vast overhaul of its drugs and devices regulatory system, China has been placing a heavy emphasis on postmarket surveillance over the last two years. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More