豁免某些太阳灯产品制造商的报告和记录保存要求.pdfVIP

A- D E P m m E N x w H E A L - m HUMAN s m w a s Public Health Service Food and Orug Administratioi SEP 16:1981 Rockville MD 20857 TO: Manufacturers and Potential Manufacturers of Sunlamp Products (Including Tanning Booths) SUBSECT:.. Exmptian £ran Reporting and Recordkeeping ts for Certain Sunlamp Product Manufacturers BACKGROUND: The regulations in 2 1 CFR 1002 pranulgated under t h e Radiation Control f o r H e a l t h and Safety A c t of 1968 require, amng o t h e r things, that a manufacturer of an electronic product subject to a performance standard sutxnit an initial report, annual reports, and model change reports, as applicable, to the D i r e c t o r , Bureau of Radiological H e a l t h (21 CFR 1002.lo, 1002.ll and 1002-12) . Fmthermre, a manufacturer , of an electronic product subject to a perfomce standard is required to mint- certainrecords including a description of the quality control procedures with respect to theprcducts r a d i a t i o n safety, r e s u l t s of life testing and capies of written c a m n i c a t i o n s between themanufacturer, dealers, distributors and purchasers regarding r a d i a t i o n s a f e t y (21 CFR 1002.30 (a) 1 and preserve such