CDRH Standards Program/Standards Management Staff
Office of the Center Director
- Building 66, Room 3632
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.
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.
|Deputy Director||Sharon Lappalainen||301-796-6322|
|Public Health Advisor||Terri D. Bailum||301-796-6574|
|Public Health Advisor||Maureen Gallagher||301-796-6575|
|Senior Standards Advisor||Hany Demian||301-796-6420|
|Senior Standards Advisor||Rui Peng||301-796-2638|
|Senior Standards Advisor||Jianchao Zeng||301-796-6580|
|Senior Standards Advisor||Ponleaarun (Arun) Le||301-796-0458|
|Senior Standards Advisor||Colleen Lee||301-796-6576|
How to use this program
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