Zdrowie i gospodarka · 18.05.2010
Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to Manufacturers and Distributors to Voluntarily Submit Final Product Labeling and Information Electronically for all Devices Cleared by the Food and Drug Administration for Home Use; Notice of Pilot Program
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 to allow 60 days for public comment in response to the notice. This notice solicits comments regarding the request that manufacturers and distributors of all devices cleared by FDA for home use voluntarily submit final product labeling and information electronically as a part of a pilot program to be conducted by FDA's Center for Devices and Radiological Health (CDRH). FDA is requesting that manufacturers and distributors for these products submit final product labeling and information in a standard Structured Product Labeling (SPL) format that we intend to eventually place on a home use device product portal that will be accessible to the public.