Regulatory Focus™ > News Articles > US Regulators Want New Look at Radiation-Emitting Products

US Regulators Want New Look at Radiation-Emitting Products

Posted 28 January 2013 | By Alexander Gaffney, RAC 

Medical device regulators with the US Food and Drug Administration (FDA) stand to benefit from a new support program announced on 28 January 2013 that promises to support the agency's mission of better protecting consumers against radiation.

That support, announced in a Federal Registerposting, will come in the form of a grant awarded to an entity that FDA expects will be able to facilitate cooperation between state, federal and tribal entities in order to improve radiation protection.

FDA's oversight of radiation products brings it into close contact with the work of the Nuclear Regulatory Commission (NRC) and the Environmental Protection Agency (EPA), both of which regulate different aspects of the use and control of radiation-emitting products, as well as public health agencies like the Federal Emergency Management Agency (FEMA).

Working with these groups, FDA said it has been able to address certain problems in an ad hoc manner. Working groups and committees are generally formed to address specific problems, and educational activities are developed on an as-needed basis as well.

But now, FDA said it wants to support something of a more sustained effort, with a focus on three areas of importance to medical device products: X-rays, the application of medical non-ionizing radiation, and the general mitigation of radiation exposure from "all sources."

The grant-$400,000 in 2013-will support a wide range of initiatives related to X-rays, including general diagnostic and therapeutic radiology, medical imaging issues, therapy radiography practice guidelines and assurance procedures, and the exposure of patients to radiation.

In addition, FDA said the recipient of the grant would be responsible for developing criteria on how to respond to radiation accidents or incidents, evaluating state radiation control programs and the oversight of radiation laboratory capabilities, and reviewing and providing comment on radiological security.

The latter could come to be significant for medical device companies due to their devices' use in potentially unsecured facilities. Two reports published in 2012 indicated that those devices could be used as the basis for a radiological "dirty bomb," and FDA could be interested in working with NRC regulators to better control how the devices are secured.

To that end-and surely others-FDA is also calling on the grant recipient to "refresh and update previously developed consensus guidance documents and Suggested State Regulations for the Control of Radiation (SSRCR).

"The recipient will be required to develop a process to determine the need, priority, and timing for regulation updates and development of new SSRCRs," FDA explained. "This shall include collaboration with the Federal Agencies, in accordance with Federal statutes and regulations that are providing access to rules that are still under development to enable the recipient to initiate timely development or revisions in parallel."

Applications for the grant will be accepted between 28 January 2013 and 1 April 2013, with an anticipated start date of 1 May 2013.


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