Data / Federal rules / 2025-11791

Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation

The Food and Drug Administration published this final rule in the Federal Register on June 26, 2025. It took effect on June 26, 2025.

SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.

Get new rules for your industry

What the agency says

The Food and Drug Administration (FDA, the Agency, or we) is classifying the cream for x-ray attenuation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cream for x-ray attenuation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key facts

Document number: 2025-11791
Type: Final rule
Action: Final amendment; final order
Agency: Health and Human Services Department; Food and Drug Administration
Published: June 26, 2025
Takes effect: June 26, 2025
Dates: This order is effective June 26, 2025. The classification was applicable on May 9, 2013.
Docket: Docket No. FDA-2025-N-1361
Code of Federal Regulations: 21 CFR 892
Topics: Medical devices; Radiation protection; X-rays
Pages: 3

The document on federalregister.gov PDF

Other documents from the Food and Drug Administration

Document	Type	Published
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability 2026-21670	Proposed rule	Oct 23
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability 2026-21669	Proposed rule	Oct 23
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate 2026-20979	Final rule	Oct 14
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods 2026-20848 · significant	Final rule	Oct 13
Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens 2026-20727	Final rule	Oct 9
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use 2026-20726	Final rule	Oct 9
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit 2026-20725	Final rule	Oct 9
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability 2026-20721	Proposed rule	Oct 9

Everything from the Food and Drug Administration · Rules on medical devices · Rules on radiation protection · Rules on x-rays · Published in June 2025

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.