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
fda-device · Food and Drug Administration · Rule · Published 2023-01-20 · Effective 2023-02-21 · 88 FR 3638
Document
Document number
2023-00922
Federal Register citation
88 FR 3638
CFR reference
21 CFR 1000
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2023-01-20
Effective date
2023-02-21
HHS docket
Docket No. FDA-2018-N-3303
Abstract
The Food and Drug Administration (FDA, Agency, or we) is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.