FDAFinal Rule
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
HealthcareTechnology
Ad Space (leaderboard)
Summary
The FDA is officially classifying a cream used to protect patients' skin during X-ray procedures. This regulation establishes safety and effectiveness standards that manufacturers must follow to ensure the product works as intended and doesn't harm patients during medical imaging.
Key Points
- 1The FDA is categorizing a special cream designed to block X-rays from reaching the skin during radiology procedures
- 2Manufacturers of this cream must now meet specific FDA requirements for safety testing and labeling
- 3The classification helps ensure patients are protected from unnecessary radiation exposure during medical imaging
- 4This rule applies to companies that make or sell X-ray attenuation creams for medical use
- 5The regulation took effect on June 26, 2025, establishing the regulatory pathway these products must follow
Key Dates
Published
June 26, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
The Digest Network
Ad Space (rectangle)