The FDA has opened a public comment period on the continuation of a pilot project evaluating the electronic collection of the 3500A form for adverse device events.
The project is intended to obtain data from user facilities participating in the Medical Product Safety Network (MedSun). The electronic form will also 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, is a moderated site where MedSun members can share information with each other.
Written comments must be submitted by Aug 13. Comments on the collection of information can be submitted online.