12 Mar
FDA postpones foreign medical device inspections due to COVID-19 concerns
The U.S. Food and Drug Administration is postponing inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April 2020, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For medical device manufacturers based outside the US which are dependent on FDA inspections to obtain US market registration, this announcement may mean delays in premarket application reviews.
FDA states that although temporarily not being able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure FDA will employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. For example, FDA began exercising this authority when postponing on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.
As this remains a dynamic situation, FDA will continue to assess and calibrate their approach as needed to help advance federal response efforts in the fight against this outbreak.
Please read the full FDA statement here
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