FDA Notices To Manufacturers

In addition to the code published in the Federal Register, the FDA periodically distributes notices to all manufacturers, importers and potential manufacturers of sunlamp products, clarifying general policy guidelines. These notices may serve the purpose of rectifying widespread instances of noncompliance by ensuring that the standard is understood, or of informing all interested parties that changes in the standard itself are imminent.

In the months before the amended version of 21 CFR 1040 took effect in 1986, two notices were sent to inform all manufacturers, importers and potential manufacturers of sunlamp products of the impending changes in timer intervals and lamp compatibility. In June 1985, the FDA had sent a notice to encourage manufacturers and importers to be sure their product labeling was in compliance with the standard.

Although these notices are written principally for manufacturers and importers, salon operators also may find them useful as a "plain-English" description of certain aspects of the code with which their equipment must comply. The notices are as follows:

Date: June 25, 1985

To:  All Manufacturers, Importers and Potential Manufacturers of Sunlamp Products.

Subject: Policy on Warning Label Required on Sunlamp Products.

Sunlamp products are electronic products as defined by Section 355(2) [42 U.S.C. 263c(2)] of the Radiation Control for Health and Safety Act of 1968 (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug and Cosmetic Act (FD&C) [21 U.S.C. 321(h)(3)]. The performance standard for sunlamp products (21 CFR 1040.20), promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided to the user and 21 CFR 801.15 defines the prominence of the required label statements for devices.