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Industry Support  
Assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products

Office of Communication, Education, and Radiation Programs (OCER) - What We Do
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Office Description

The Office of Communication, Education, and Radiation Programs (OCER), Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA), specializes in program-based communication, education, radiological health, mammography quality, and reduction in use error. Outreach and education are common themes in every aspect of OCER's work. Our varied programs include producing teleconferences, training CDRH staff, working with and educating patients/consumers/health professionals, assuring high quality mammography, conducting radiation safety surveys, assisting medical device manufactures, coordinating international medical device activities, and developing medical device regulations.

Because of the breadth of our role within CDRH, OCER serves a wide variety of customers. Our customers include domestic and foreign manufacturers of medical devices and radiation-emitting electronic products, domestic and foreign government agencies engaged in public health and/or the regulation of medical devices, healthcare professionals/organizations, consumers, patients, and CDRH staff. The services we provide directly affect the lives of millions of Americans and ultimately promote the health of the public.

Programs

OCER is responsible for providing consumers with information needed to make informed decisions on the use of medical devices and radiation-emitting electronic products
  • International Activities
 OCER is the Center's point of contact for International Issues and programs such as the US/EU Mutual Recognition Agreement (MRA).
  • Manufacturer Assistance
 OCER provides regulatory assistance and informational materials to regulated industry through a variety of initiatives including: Device Advice, the Accredited Persons Program, Workshops, and Guidance.

Nearly one-third of our staff are involved in radiological health programs. They include mammography, and the Technical Electronic Product Radiation Safety Standards Advisory Committee

CDRH has consolidated the radiological health functions housed in the Office of Compliance (OC) into the radiological health program of the Office of Communication, Education, and Radiation Programs (OCER) (formerly the Office of Health and Industry Programs).

As of October 1, 2004 , the Diagnostic Devices Branch and the Electronic Product Devices Branch from OC are two new branches in the Division of Mammography Quality and Radiation Programs in OCER.

The consolidated radiological health staff in OCER will work with other CDRH Offices to set a new direction for the Center’s radiological health program, increasing its relevance to, and impact on, the most pressing current public health problems, and to anticipate and keep pace with the evolution of medical radiation systems.

All Product report forms and guidance documents related to 21 CFR 1000-1050, radiation-emitting product performance standards can still be found at: www.fda.gov/cdrh/comp/eprc.html. Guidance as to what reporting responsibilities a manufacturer of a radiation-emitting product has can be found at: http://www.fda.gov/cdrh/devadvice/311.html .

OCER promotes the safe and effective use of medical devices through the Human Factors program, labeling efforts, and patient safety activities.
OCER conducts outreach programs to educate single-use-device reprocessors about their regulatory requirements
The User Facility Reporting Bulletin provides user facilities with important information on preventing adverse events with medical devices, directions for reporting adverse events to the FDA; and feedback on reported problems
Information for mammography facility personnel, inspectors, and consumers.

Annual Reports

Updated October 27, 2004

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