Code of Federal Regulations Title 21. Food and Drugs § 21.1002.50 Special exemptions

(a) Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in table 1 of § 1002.1. The request must specify each requirement from which an exemption is requested. In addition to other information that is required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested does not pose a public health risk and meets at least one of the following criteria:

(b) The Director may, subject to any conditions that the Director deems necessary to protect the public health, exempt manufacturers from all or part of the record and reporting requirements of this part on the basis of information submitted in accordance with paragraph (a) of this section or such other information which the Director may possess if the Director determines that such exemption is in keeping with the purposes of the Act.

(c) The Director will provide written notification of the reason for any denial. If the exemption is granted, the Director will provide written notification of:

(d) The Director may, on the Director's own motion, exempt certain classes of products from the reporting requirements listed in table 1 of § 1002.1, provided that the Director finds that such exemption is in keeping with the purposes of the act.

(e) Manufacturers of products for which there is no applicable performance standard under parts 1020 through 1050 of this chapter and for which an investigational device exemption has been approved under § 812.30 of this chapter or for which a premarket approval application has been approved in accordance with § 814.44(d) of this chapter are exempt from submitting all reports listed in table 1 of § 1002.1.