Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages
For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators
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- Medical Devices and the COVID-19 (Coronavirus) Pandemic
- Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19
- FAQs on Emergency Use Authorizations (EUAs) for Devices - COVID-19
- FAQs on Diagnostic Testing for SARS-CoV-2
- FDA Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2 Infection
- FAQs on Ventilators
- Face Mask (Non-Surgical) Emergency Use Authorization (EUA) Frequently Asked Questions
Some medical devices are used to prevent or treat emergency situations. These include diagnostic equipment and tests, personal protective equipment such as masks or gloves, and surgical tools and supplies.
Other medical devices have no bearing on the emergency, but may be adversely affected by conditions such as loss of power, moisture, or contamination.
On Feb. 21, 2013, the FDA issued a Federal Register notice requesting comments from the public on three scenarios related to medical devices and extreme weather, such as hurricanes, floods, lightning storms, earthquakes, and fires. Extreme weather events and natural disasters can interfere with the manufacturing, shipping, storage, or use of marketed devices, which may lead to concerns with their safety or effectiveness. The FDA will use this information to help determine how it can optimize its current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. To submit comments, please see Federal Register Notice: Extreme Weather Effects on Medical Device Safety and Quality.
- Federal Register: Extreme Weather Effects on Medical Device Safety and Quality
- Federal Register: Device Good Manufacturing Practice Advisory Committee; Notice of Meeting