FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

FDA works with manufacturers to help ensure the application of human factors engineering to the design of new products.

FDA's human factors program:

• Evaluates manufacturers' design validation documents required by the Quality System Regulation;
• Develops Guidance documents to help manufacturers understand and use human factors engineering;
• Educates manufacturers about the need for human factors programs;
• Provides training and guidance for other FDA personnel about the importance of human factors in product design;
• Inputs human factors principles into medical device standards;
• Collaborates with professional organizations to educate the public about human factors; and
• Encourages users and manufacturers to report serious adverse incidents involving medical devices through the Medical Device Reporting (MDR) system.

Updated 3/13/2003

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH