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The FDA has updated its device shortage list to reflect changes in the estimated shortage durations for six categories of medical devices, continuing its monitoring of the supply chain in light of the high demand and shortages resulting from the COVID-19 public health emergency.
The FDA’s Center for Diagnostic and Radiological Health (CDRH) has released a schedule of upcoming enhancements to its Electronic Medical Device Reporting (eMDR) system to provide early notice to manufacturers.
As part of its Medical Device User Fee Amendments (MDUFA) goals for 2023-2027, the FDA’s Center for Diagnostic and Radiological Health (CDRH) has added new functions to its portal where device sponsors can send in and track their premarket submissions.
The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday.
According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.
In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.