Health and Human Services Department, Food and Drug Administration
FDA is announcing the following public meeting on the draft guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications." This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2012-N-0385] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; request for comments. SUMMARY: FDA is announcing the following public meeting on the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.” This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research. DATES: Date and Time: The meeting will be held on July 16, 2012, from 8 a.m. to 5 p.m. Location: The meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm . Contact: Thalia Mills, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4527, Silver Spring, MD 20993, 301-7…
Citation: 77 FR 27463
