Zdrowie i gospodarka · 9.07.2010
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products
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 collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the continuation of a pilot project to evaluate the electronic collection of the 3500A Form for adverse events related to the use of medical products to obtain data from user facilities participating in the Medical Product Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions related to the use of medical products. It will no longer contain the page called Device-Safety Exchange (DS-X) (formerly called M-Den), which was a moderated site where MedSun members shared information with each other. This will be replaced by a page where questions about possible emerging signals will be asked of the MedSun sites.