Food And Drug Administration

1. An initial report (see 1002.10) for each product family which:

a. Identifies models within the reported model family and their intended uses.

b. Describes the nature of radiation emissions associated with those products and the performance and safety characteristics affecting such emissions.

c. Details manufacturer design, quality control, and testing standards and procedures with respect to product radiation and safety.

2. Model change reports (see 1002.12) for each new or different model family.

3. Annual reports which summarize the contents of records maintained by the manufacturer (see 1002.30(a).

Initial and model change reports must be filed prior to the introduction of sunlamps and sunlamp products into commerce. They are to include sufficient information to enable the determination of whether a manufacturer has correctly certified his products as being in compliance with the performance standard.

Annual reports should be submitted by Sept. 1 of each year and should cover the 12-month period beginning on July 1 of the previous year and ending on June 30 of that year.

For aid in submitting the information required in the initial and model change reports, consult the Guide for Preparing Annual Reports. The use of these reporting guidelines is mandatory.

Since the product is also a medical device, manufacturers should be aware of the provisions of the Medical Device Amendments of 1976. Among these provisions are requirements for establishment registration and pre-market notification. Also, section 807.87, paragraph (f) of the regulations requests information on substantial equivalence of the device to similar devices already in commercial distribution.

In addition, those companies which produce sunscreens, lotions and moisturizers, etc., are subject to 21 CFR part 352, titled "Sunscreen Drug Products for Over-the-Counter Human Use."