Department of Health and Human Services June 13, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed continuing 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 Device Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions related to the use of medical products. A portion of the MedSun software, called Device-Safety Exchange (DS-X) (formerly called M-Den), is a moderated site where MedSun members may share information with each other.