Standards (Medical Devices)

CDRH Standards Program/Standards Management Staff

Contact the CDRH Standards Program at: CDRH Standards Staff

OUR MISSION:

The CDRH Standards Program was established as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The program contributes to the Center’s mission of protecting and promoting public health through the development and recognition of voluntary consensus standards that serve to establish safe and effective medical devices, radiation-emitting products and emerging technologies.

OUR VISION:

CDRH stakeholders have access to high-quality, safe, and effective medical devices of public health importance first in the world through timely development and recognition of voluntary consensus standards. The CDRH Standards Program is the world’s leader in standards implementation and utilization for medical device innovation and manufacturing, and radiation-emitting product safety. Medical Device manufacturers, consumers, patients, and providers have access to voluntary consensus standards for medical devices and use this information to protect and promote the public health.

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