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HERCA and the U.S.A Food and Drug Administration sign a Memorandum of Understanding on radiation protection


Posted 30-4-2012

The Association of the Heads of the European Radiological protection Competent Authorities (HERCA) and the Food and Drug Administration (FDA)1 through its Center for Devices and Radiological Health (CDRH) as part of the U.S. Department of Health and Human Services have signed a Memorandum of Understanding (MOU) in the field of radiation protection.

HERCA and FDA share a mutual interest in promoting initiatives related to radiation protection in general and in particular those aiming at optimizing radiation dose from medical imaging and reducing unnecessary radiation exposure to patients from Computed Tomography (CT). HERCA and FDA also share a common global goal of improving the safety and effectiveness of CT devices.

Under this framework at the European level HERCA has set up a Task Force with COCIR, the European trade association representing the medical imaging, electromedical and healthcare IT industry HERCA and COCIR co-operate to address concerns related to radiation exposure in CT. On the initiative of HERCA, COCIR CT manufacturers have developed voluntary commitments contributing to the reduction of CT dose which have been welcomed by HERCA (Cf. Press release “Regulators Work With Medical Industry on Radiation Protection”). FDA has launched similar initiatives in the United States involving MITA, the Medical Imaging Technology Alliance.

The Memorandum of Understanding signed on 1 February 2012 formalizes HERCA’s and FDA’s intention to collaborate in areas of mutual interest, providing a framework for coordination and collaborative efforts between the Parties in these areas.

Jeffrey Shuren, Director of FDA CDRH, and Sigurdur Magnusson Chairman of HERCA both want to stress the importance of this MOU which will allow European and U.S. authorities to better coordinate efforts to reduce unnecessary radiation exposure from CT imaging.

For more information on this subject, please contact : O. Guzmán, Tel : +33 1 40 19 87 64 Fax : +33 1 40 19 88 36, olvido.guzman@asn.fr olvido.guzman@asn.fr; secretariat@herca.org.

1. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301). In fulfilling its responsibilities under The Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. To accomplish its mission, FDA must stay abreast of developments regarding medical imaging and communicate with stakeholders about important public health issues. Enhancing cooperation and communication regarding radiation projects will greatly contribute to the FDA’s mission.

Documents

HERCA - FDA MOU 2012

 

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