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Zdrowie i gospodarka · 19.02.2004

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation

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 including each proposed extension of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).

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