Zdrowie i gospodarka · 6/5/1998
Agency Information Collection Activities: Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and each proposed reinstatement of an existing collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on premarket notification submission 510(k), subpart E, to require a person/manufacturer who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use.