---
kind: "section"
citation: "42 C.F.R. § 405.213"
title: "42"
number: "405.213"
heading: "Re-evaluation of a device categorization."
url: "https://uscodex.org/cfr/42/405.213"
---

# §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)](#b) of this section are met.
  - (3) No reviews other than those described in paragraphs [(b)](#b) and [(c)](#c) of this section are available to the sponsor.
  - (4) Neither the FDA original categorization or re-evaluation (described in [paragraph (b)](#b) of this section) nor CMS's review (described in [paragraph (c)](#c) of this section) constitute an initial determination for purposes of the Medicare appeals processes under [part 405](/cfr/42/part405.md), [subpart G](/cfr/42/subpartG.md) or [subpart H](/cfr/42/subpartH.md), or parts [417](/cfr/42/part417.md), [473](/cfr/42/part473.md), or 498 of this chapter.
- (b) **Request to FDA.** A sponsor that does not agree with the FDA's categorization of its device may submit a written request to the FDA at any time requesting re-evaluation of its original categorization decision, together with any information and rationale that it believes support recategorization. The FDA notifies both CMS and the sponsor of its decision.
- (c) **Request to CMS.** If the FDA does not agree to recategorize the device, the sponsor may seek review from CMS. A device sponsor must submit its request in writing to CMS. CMS obtains copies of relevant portions of the application, the original categorization decision, and supplementary materials. CMS reviews all material submitted by the sponsor and the FDA's recommendation. CMS reviews only information in the FDA record to determine whether to change the categorization of the device. CMS issues a written decision and notifies the sponsor of the IDE and the FDA.

## Notes

### Amendments

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74810, Dec. 10, 2013

### Authority

Authority: Secs. 1102, 1862 and 1871 of the Social Security Act as amended (42 U.S.C.1302, 1395y, and 1395hh).

### Source

Source: 60 FR 48423, Sept. 19, 1995, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

### Amendments

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74810, Dec. 10, 2013