Standards (Medical Devices)

CDRH Standards Program/Standards Management Staff

Office of the Center Director

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

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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.

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Organization:

Director	Scott Colburn	301-796-6287
Acting, Deputy Director	Sharon Lappalainen	301-796-6322
Public Health Advisor	Terri D. Bailum	301-796-6574
Public Health Advisor	Maureen Gallagher	301-796-6575
Standards Coordinator	Patricio Garcia	301-796-6875
Standards Coordinator	Jianchao Zeng	301-796-6580
Standards Coordinator	Ponleaarun (Arun) Le	301-796-0458
Standards Coordinator	Tracey Lee	301-796-0457