Standards Management Staff

Office of the Director

• 301-796-6574
• Building 66, Room 3632

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

The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. CDRH is invested in the development of medical device standards and participates significantly in the development process. SMS manages the Standards Program, a regulatory support activity consisting of cross-office teams within CDRH and FDA. This involves working closely with the Standards Developing Organizations (SDOs), advertising standards liaison representative positions, facilitating a Center recommendation to serve on a particular standards activity, and maintaining an appropriate standards database providing access to established standards for all CDRH staff, field inspectors, and industry. SMS continually updates currently recognized standards and coordinates the recognition of new voluntary consensus standards for medical devices and radiation-emitting electronic products. SMS ensures appropriate medical device standards are published in the Federal Register at least twice annually. The Standards Program was created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. Although CDRH had been involved in the development of medical device standards for decades, FDAMA formalized the process.

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)