What Happens When FDA Ends Medical Device and IVD Emergency Use Authorizations (EUAs)?

Throughout the spring and summer of 2020, there was a mad rush to get ventilators, COVID-19 tests, masks, and personal protective gear on the market as quickly as possible. The existing supply of FDA-cleared / -approved devices and in vitro diagnostics (IVDs) could not come close to filling the need, so FDA granted emergency use authorizations (EUAs) for dozens of products. Established medical device manufacturers jumped in to fill the void but so did companies that had no previous experience […]

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COVID-19 Regulatory Resources for Medical Device and IVD Manufacturers

FDA and other global regulators have been rapidly publishing information intended to help manufacturers respond to the COVID-19 crisis. On this page we have posted helpful links to various Regulatory Authority webpages and other information specifically related to COVID-19. Please email us links to English-language web pages (useful to regulatory professionals) as you find them. Thank you! US FDA – See main COVID-19 page for industry UK MHRA – See main COVID-19 page for industry HEALTH CANADA – See main […]

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Get Your Medical Device or PPE on the EU Market to Help with COVID-19. Here’s How.

In the age of COVID-19, there may be confusion around how to get a medical device into the EU market to support European citizens grappling with this devastating pandemic. We are experiencing an exceptional event, and regulators know that they play a key role in getting life-saving medical devices and personal protective equipment (PPE) to market as quickly as possible. Manufacturers that have the desire and ability to ramp up their manufacturing capacity to fulfill unmet needs in the EU […]

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