Regulatory Counsel

0910-AH65 202204 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 clarify and update FDA radiological health regulations by repealing and amending parts of the general provisions, records and reports requirements, and electronic performance standards for radiation emitting electronic products and medical 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 revisions will amend and repeal certain radiation protection recommendations, reporting requirements for certain electronic products, and performance standards that have been identified as outdated or duplicative of other means to better protect public health.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 1000.3 21 CFR 1000.50 21 CFR 1000.55 21 CFR 1000.60 21 CFR 1002.1 21 CFR 1002.2 21 CFR 1002.13 21 CFR 1002.20 21 CFR 1010.4 21 CFR 1020.30 21 CFR 1040.10 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 NPRM 04/01/2019 84 FR 12147 NPRM Comment Period End 07/01/2019 Final Rule 12/00/2022 No No None No No No No Rachael Hunt Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-5244 rachael.hunt@fda.hhs.gov 10903 New Hampshire Avenue, Building 66, Center for Devices and Radiological Health, Silver Spring MD 20993