Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers
Published: 1981-09-16
Status: Final Type: Guidance Document Category: Radiation / Imaging Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exemption-reporting-and-record-keeping-requirements-certain-sunlamp-product-manufacturers PDF: https://www.fda.gov/media/73639/download
Official Full Text
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 21 CFR 1002 pranulgated under the Radiation Control f o r H e a l t h and Safety A c t of 1968 require, amng other 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 mintcertain records including a description of the quality control procedures with respect to the prcduct's radiation 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 the manufacturer, dealers, distributors and purchasers regarding radiation safety (21 CFR 1002.30 (a) 1 and preserve such records f o r a period of 5 years £ran the date of the record (21 CFR 1002.31(a)), The Bureau's experience in the e n f o r m t of the performance standard for sunlamp p r d u c t s (21 CE'R 1040.20) indicates that the above referenced reporting and recordkeeping requirertrtnts seem to be an overburden for an individual or fh who manufactures on a one time or infrequent basis a small nunher of sunlamp products (usually less than 10) f o r his awn use. FSrapthg this type of marmfacturer £ran the referenced reporting and recordkeeping requirerrrents under certain conditions would not carrpranise the spirit or purpose of the Act since FDA can determine c q l i a n c e through product inspections. EXEWTICkJ: Any person who manufactures less than 10 sunlamp products for use in their am carnercial suntanning facilities is hereby exempted under the authority of 21CFR 1002.50 £ran the requirements of 21 CFR 1002.10, 1002.11, 1002.12, 1002-30 and 1002.31 provided t h a t such person n o t i f i e s the D i r e c t o r , Division of Capliance, that less than 10 sunlamp products are being manufactured for the use of that person and provides the D i r e c t o r with the name and address of t h e manufacturing location. Persans who wish to manufacture mre than 10 sunlmp products f o r use in their own -cia1 sunLLanning facilities are not included in this exerrrptian but my IMke a written application for exemption to the D i r e c t o r , Bureau of Radiological Health, in accordance w i t h 21 CFR 1002.50 stating the ncanber of products they intend to manufacture and over what period of time manufacturing w i l l occur. / / Bureau of Radiological Health i