FDA Invites Comments on Reporting Requirements for Firms that Export Unapproved Medical Devices

January 31, 2022

The FDA has asked for comments on reporting requirements for firms that intend to export certain unapproved medical devices from the U.S.

The Food, Drug and Cosmetic Act allows for exportation of a device that is not FDA-approved if the exporting company gets a written authorization from the foreign government or a notarized certification from a responsible company official in the U.S. that the product is not in conflict with the foreign country's laws. 

More U.S. device companies are exporting such products and the FDA must collect the required information, the agency said in a Jan. 25 notice. The agency invited comments on its proposed collection of information until March 29.

Read the notice here: www.fdanews.com/01-28-22-FederalRegister.pdf.

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