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Draft guidance has been issued that describes a proposed Food and Drug Administration (FDA) policy regarding the regulation of medical x-ray imaging equipment that is subject to requirements in the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products. In this draft guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control [EPRC]) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure streamlined regulatory review of submissions for these products.
The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA believes industry conformance to certain IEC standards would provide the same level of or improved protection of the public health and safety from electronic radiation as certain EPRC regulatory standards. The FDA also believes conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain devices. An FDA review of related radiological health and safety data in premarket submissions, as opposed to EPRC product reports, would maintain or improve device safety while consolidating the information manufacturers submit to FDA.
The FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Comments and suggestions regarding this draft document should be submitted within 90 days of the 3 August 2016 publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments on the regulations.gov website. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Identify all comments with the Docket No. FDA-2016-D-2049.