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42 C.F.R. § 405.213

Re-evaluation of a device categorization.

§ 405.213 Re-evaluation of a device categorization.

(a) General rules. (1) Any sponsor that does not agree with an FDA decision that categorizes its device as Category A (experimental) may request re-evaluation of the categorization decision.

(2) A sponsor may request review by CMS only after the requirements of paragraph (b) of this section are met.

(3) No reviews other than those described in paragraphs (b) and (c) of this section are available to the sponsor.

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