The following are Federal Agency conformity assessment programs. Detailed information about a specific program can be found by clicking on the progam name.
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.
In December 2008, the Assistant Deputy Under Secretary of Defense (Environment, Safety and Occupational Health) issued a memorandum establishing the DoD Environmental Laboratory Accreditation Program (DoD ELAP), which requires laboratories that perform testing in support of the Defense Environmental Restoration Program to be accredited. DoD ELAP utilizes third party Accreditation Bodies, which must be U.S.-based signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), to assess laboratories to ISO/IEC 17025:2005 as implemented by the DoD Quality Systems Manual for Environmental Laboratories (DoD QSM).