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Astrid Fiano, DOTmed News Writer | March 04, 2010
--Should manufacturers incorporate features into CT and fluoroscopic equipment to facilitate transmission of technique parameters, imaging protocols, and dose metrics to a patient's imaging record, an electronic health record, or other database? If so why and how? If not, why not?
--Should manufacturers submit more data to FDA as part of their pre-market submissions for approval or clearance of CT and fluoroscopic devices, related to the safety and effectiveness of these devices? If so, why, and what data should be submitted? If not, why not?
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--Should manufacturers submit technical data to FDA as part of their pre-market submissions for approval or clearance of CT and fluoroscopic devices, demonstrating dose reduction and image quality claims? If so, why, and what data should be submitted? If not, why not?
--What changes should manufacturers make to CT and fluoroscopic devices currently on the market in order to reduce unnecessary patient exposure to ionizing radiation?
--Should manufacturers provide training to medical imaging equipment users to ensure adequate understanding of equipment capabilities, operating principles for the technology, general information about optimizing patient dose and image quality, and specific dose-reduction equipment features? If so, why, and what training should be provided? If not, why not?
--What tools and metrics should FDA, in collaboration with others in the Federal Government and the health care professional community, use to evaluate the impact of efforts to reduce unnecessary radiation?
The complete notice can be accessed by going to http://www.regulations.gov/search/Regs/home.html#home and searching by the Docket No., FDA-2010-N-0080. Persons who would like to attend or participate in the meeting, which will not be videotaped or on webcast, must register by 5 p.m. on March 15, 2010. The meeting will take place in Gaithersburg, MD 20879. Registration can take place by emailing CDRHimaginginitiative(at)fda.hhs.gov. The FDA will also accept written or electronic comments on the issues in this meeting until April 15, 2010. Written comments can be directed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Electronic comments can be submitted to http://www.regulations.gov.
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