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Topics (CFR Indexing Terms)
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
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,...
The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.
The Food and Drug Administration (FDA or Agency) is proposing to amend the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. This standard was last amended in 1985. The current amendments seek to improve consumer safety by requiring more effective communication regarding the risks posed by...
The Food and Drug Administration (FDA or Agency) is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standards for laser products and medical laser products, to reduce the economic burden on affected manufacturers,...
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct statutory and regulatory references to ensure accuracy, consistency, and clarity in the agency's regulations.