Medical Devices
Standards (Medical Devices)
CDRH Standards Program/Standards Management Staff
Office of the Center 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:
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 |
Guidance
Frequently Asked Questions on Recognition of Consensus Standards Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards Guidance for Industry and for FDA Staff: Use of Standards in Substantial Equivalence Determinations CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition