Medical Device Industry Resource Center

Industry Specific Definitions

This page defines compliance terms and acronyms used by the medical device industry.

About the FDA Center for Devices and Radiological Health
CDRH protects the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted from electronic products.

CDRH Organizational Chart
This organizational chart provides names and phone numbers of those working in key positions at CDRH.

CDRH Fact Sheet [HTML] [PDF]
This brochure explains CDRH's responsibilities and provides contact information for the center.

CDRH's Strategic Plan
This site details CDRH's strategic plan for the years 2000-2005.  It includes information on CDRH's mission, vision, strategic goals, and strategic plan implementation.

FDA Centennial at CDRH
This site commemorates the 100th anniversary of Food and Drug Administration (FDA) and the major milestones celebrated by the Center for Devices and Radiological Health (CDRH) in 2006.

Referral List

Medical Devices - Industry Assistance
At this site, FDA provides assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products.

Radiation-Emitting Products - Industry Assistance
This is another site FDA provides for manufacturers of radiation emitting products.

FDA's New Office of In Vitro Diagnostic Device Evaluation and Safety  
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) combines the functions of all the offices within Center for Devices and Radiological Health (CDRH) into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs).

Regulatory Issues

Device Advice
Device Advice is CDRH`s self-service site for medical device and radiation emitting product information. Device Advice is an interactive system obtaining information concerning medical devices.

Medical Device Quality Systems Manual: A Small Entity Compliance Guide
This manual covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.

Medical Device User Fee and Modernization Act of 2002
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges.    User fees for premarket reviews; establishment inspections may be conducted by accredited persons (third-parties); new regulatory requirements for reprocessed single-use devices.  This site contains information on MDUFMA.

for News In the Medical Device Industry