Medical Devices

Standards (Medical Devices)

CDRH Standards Program/Standards Management Staff

Contact the CDRH Standards Program at: CDRH Standards Staff


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.


TitleNamePhone number
DirectorScott Colburn301-796-6287
Deputy DirectorSharon Lappalainen301-796-6322
Public Health AdvisorMaureen Gallagher301-796-6575
Senior Standards AdvisorShuliang Li240-402-3798
Senior Standards AdvisorRui Peng301-796-2638
Senior Standards AdvisorJianchao Zeng301-796-6580
Senior Standards AdvisorPonleaarun (Arun) Le301-796-0458
Senior Standards AdvisorColleen Lee301-796-6576
Senior Standards AdvisorDonna Walsh301-796-2498

Page Last Updated: 03/27/2018
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