Can a confidential agency submission support a public claim broader than its stated question?
Last reviewed: .
Can a confidential agency submission support a public claim broader than its stated question?
No: a submission speaks only to the question it asked, and the company's classification rests on no agency submission.
The company's classification rests on two things and nothing else: the definition of a device at 40 C.F.R. § 152.500(a), and the article as described in the company's Statement of Classification. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. The company publishes no agency decision about the article and claims none. 40 C.F.R. § 156.10(a)(5) lists as misbranding “a true statement used in such a way as to give a false or misleading impression to the purchaser”, and a public claim drawn wider than the question that was actually asked would be exactly that.
Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.6 and 3.7, issued by NF Technical Products Inc.; 40 C.F.R. §§ 152.500 and 156.10, as published on eCFR.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, sections 3.6, 3.7
- 40 C.F.R. § 152.500
- 40 C.F.R. § 156.10(a)(5)