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SIMPLIFIED (SECTION) 10(k)s FOR SOME RADIOLOGY DEVICES ARE ACCEPTABLE

This article was originally published in The Gray Sheet

Executive Summary

SIMPLIFIED (SECTION) 10(k)s FOR SOME RADIOLOGY DEVICES ARE ACCEPTABLE as of Jan. 1, FDA says in a Dec. 21 letter to the National Electrical Manufacturers Association, In 510(k)s for "certain" x-ray and computed tomography systems, sponsors "need only to certify that the device meets the applicable requirement" of FDA's Performance Standard for Ionizing Radiation Emitting Products, FDA tells NEMA. Previously, 510(k)s had to include data demonstrating compliance with the standard. Under the new policy, "all data should be available for inspection at the firm," the agency stipulates.

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