Regulatory Counsel

0910-AH65 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products

The rule will update FDA radiological health regulations and withdraw parts of the general provisions, records and reports requirements, and electronic performance standards for radiological devices. Current regulations contain radiation protection recommendations, reporting requirements for manufacturers and assemblers of electronic products, and performance standards for certain electronic products. Some of the current regulations apply to electronic products (i.e., not necessarily having a medical application) but not devices (i.e., having a medical application). The regulation would eliminate radiation protection recommendations, reporting requirements for certain electronic products, and performance standards that have been identified as obsolete and no longer necessary.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 1000.3(s) 21 CFR 1000.50 21 CFR 1000.55 21 CFR 1000.60 21 CFR 1002.1 21 CFR 1002.2 21 CFR 1002.13(c) 21 CFR 1020.30(d)(1) 21 CFR 1040.10(j) 21 CFR 1050 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360 21 U.S.C. 360e to 360j 21 U.S.C. 360hh to 360ss 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 No Direct Final Rule 09/00/2018 No No None No No No No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993