FDA Approves Mystery Cream That Blocks X-Rays—Superhero Lotion?
Published Date: 6/26/2025
Rule
Summary
The FDA is officially putting the cream used to block x-rays into a special safety category called Class II. This means the cream will have clear rules to keep it safe and effective, making it easier for patients to get new and helpful products. This change helps companies by cutting some red tape without costing extra time or money.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Cream Classified as Class II
The FDA is placing the cream for x-ray attenuation into Class II (special controls). The FDA says this Class II classification and its codified special controls provide a reasonable assurance of the device's safety and effectiveness.
Easier Access to New Radiology Creams
The FDA says classifying the cream into Class II will enhance patients' access to beneficial innovative devices by reducing regulatory burdens. This is intended to make it easier for patients to get new x-ray attenuation cream products.
Reduced Regulatory Burden for Makers
The FDA says the Class II classification reduces regulatory burdens for companies that make the cream for x-ray attenuation, cutting some red tape. The summary states this change reduces burdens without costing extra time or money.
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