美国FDA 指导原则 太阳灯产品须附有警告标签的政策(只适用于PDF) 英文原版.pdfVIP

Public Health Service - - Food and Drug Adm~n~stration 8757 Georgia Avenue Silver Spring MD 2091 0 TO: ALL MANUFACTURERS, IMPORTERS AND POTESJTIAL MANUFACTURERS OF SUNLAMP PRODUCTS. SUBJECT: POLICY ON WARNING LABEL REQUIRED ON SUNLAMP PRODUCTS. BACKGROUND: The Center f o r Devices and Radiological Health has f o b d numerous inported and dcmestic sunlamp products labeled i n such a way a s t o render the label i l l e g i b l e and/or inaccessible to view by the consumer under normal conditions of purchase and use. Sunlamp products a r e electronic products a s defined by Section 355(2) [42 U.S,C 263c(2)1 of the Radiation Control f o r Health and Safety A c t of 1968 (RCHSA) and medical devices a s defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FDC) [21 U.S.C.321(h)(3)1. The performance standard f o r sunlamp products (21 CFR 1040.20) promulgated under authority of Section 358 of the RCHSA, requires t h a t labels containing specific information be permanently affixed o r inscribed on an exterior surface of the product s o a s to be legible and readily accessible t o view when the product is f u l l y assembled f o r use. The general labeling provisions f o r medi