2019-05822: 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

Summary

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend and repeal 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 The Agency is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

The agency’s own summary, as published.

What this changes

Amends 6 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 1000 General
• 21 CFR 1002 Records and Reports
• 21 CFR 1010 Performance Standards for Electronic Products: General
• 21 CFR 1020 Performance Standards for Ionizing Radiation Emitting Products
• 21 CFR 1040 Performance Standards for Light-Emitting Products
• 21 CFR 1050