Medical device shortages during the COVID-19 public health emergency
- FDA is providing a device shortage list as part of the implementation of section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The device shortage list reflects the categories of devices that the FDA has determined to be in shortage at this time, and will be updated as the COVID-19 pandemic evolves. In addition, the FDA is providing a list of medical devices for which manufacturing has been permanently discontinued. Under section 506J, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing. The publication of these lists allows for transparency to the public and stakeholders about devices shortages and manufacturing that has been permanently discontinued. (August 14, 2020)
FDA is providing two new flowcharts and supporting information on respirators
FDA posts regulatory science tools to help assess new medical devices
- FDA posted to our website a catalog of regulatory science tools to help assess new medical devices. This catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available. The tools include: laboratory methods, computational models and simulations, and physical and virtual phantoms. (August 17, 2020)
The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 50 COVID-19-related guidances to date.
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