COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 390.100 Definition of "Commerce" - 21 CFR 1000.3(d)
Section 538(a)(1) of the Federal Food, Drug, and Cosmetic Act, Subchapter C-Electronic Product Radiation Control prohibits the introduction into commerce of any electronic product which does not conform to an applicable standard.
Questions have been raised as to whether a person who manufactures an electronic product for which a standard has been prescribed, for use solely in his own commercial activities or manufacturing process, has introduced the product into “commerce”.
Such a person would not have introduced the product "into commerce" within the meaning of Section 538(a)(1). However, Section 538(a)(5) of the Act makes it a prohibited act for any person to fail to issue a certification as required by Section 534(h), regardless of whether the electronic product in question has itself been physically introduced into commerce. The assembly and use of an electronic product by a person "engaged in the business" of assembling that product (as defined in Section 531(2) for commercial purposes in his own facility affects interstate commerce; thus Section 534(h) would require that the manufacturer certify that the product conforms to the relevant standard. However, if that person in no way receives compensation for the assembly and use of the product, he would not be "engaged in the business" and therefore would not be a "manufacturer" subject to Section 534(h) and 538(a)(5).
*Material between asterisks is new or revised*
Revised: 3/95, 3/2005
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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