I agree that the FDA would be a good place to start. I only know people on the Drug side, so I am not sure who to have you talk to about devices.
I would start with Josh Simms who is in charge of Cardio Devices in the Division of Manufacturing and Quality at 301-796-5540, or maybe someone in the Office of Device Evaluation. Mark Feliman at 301-796-5630 is in charge of Cardiac Electrophysiology Devices, but I think he works more on the approval side.
I would start with Josh Simms who is in charge of Cardio Devices in the Division of Manufacturing and Quality at 301-796-5540, or maybe someone in the Office of Device Evaluation. Mark Feliman at 301-796-5630 is in charge of Cardiac Electrophysiology Devices, but I think he works more on the approval side.
The appropriate contact info for all of CDRH can be found here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalPr...