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Zdrowie i gospodarka · 29.03.2022

Medical Devices; Technical Amendments

The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations, and to remove a submission requirement that is no longer necessary.

Source: Federal Register — Food and Drug AdministrationOpen original release →