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On-Line Resources from FDA

Originally Published MX September/October 2003


The FDA Web site (, and especially the Center for Devices and Radiological Health (CDRH) home page (, provide emerging medtech companies access to numerous documents that can be useful in designing and specifying a clinical study program.

For a variety of general assistance documents, go to www.fda. gov/cdrh/industry/support ("Industry Support: Assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products").

For guidance documents available from the FDA centers and the Office of the Commissioner, go to industry/guidedc.htm ("Comprehensive List of FDA Guidance Documents"), or use the CDRH Super Search engine,
To search for documents related to regulatory submissions involving products similar to ones under development, use the CDRH Super Search engine.

o For PMAs, go to

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