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

FDA > CDRH > Standards Program > Standards Management Staff

Standards Program - Standards Management Staff

Office of the Director

• 240-276-8714
• HFZ-84

The mission of the Standards Management Staff (SMS) is to:

• manage the participation of CDRH staff in standards development,
• increases the recognition of voluntary consensus standards for medical devices and radiation-emitting electronic products. The Standards Management Program was created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. FDA has adopted Good Guidance Practices (GGP's) which set forth the Agency's policies and procedures for developing, issuing, and using guidance documents.
• manages the participation of other FDA components in medical device standards committees. Maintains a standards database that provides access to established standards to all CDRH staff.

Organization:

Internet Resources

• American National Standards Institute, Inc. (ANSI)
• ASTM International
• Association for the Advancement of Medical Instrumentation (AAMI)
• Clinical and Laboratory Standards Institute (CLSI) (formerly NCCLS)

Updated January 16, 2008

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