Medical Device Link.

Originally Published MX September/October 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

The FDA Web site (www.fda.gov), and especially the Center for Devices and Radiological Health (CDRH) home page (www.fda.gov/cdrh), 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 www.fda.gov/opacom/morechoices/ industry/guidedc.htm (“Comprehensive List of FDA Guidance Documents”), or use the CDRH Super Search engine, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/Search.cfm. 
To search for documents related to regulatory submissions involving products similar to ones under development, use the CDRH Super Search engine.

• For PMAs, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. 
• For 510(k)s, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. 
• To search by device classification, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 

Copyright ©2003 MX