---
kind: "section"
citation: "21 C.F.R. § 610.42"
title: "21"
number: "610.42"
heading: "Restrictions on use for further manufacture of medical devices."
url: "https://uscodex.org/cfr/21/610.42"
---

# §610.42. Restrictions on use for further manufacture of medical devices.

- (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device contains human blood or a blood component as a component of the final device, and the human blood or blood component was found to be reactive by a screening test performed under § [610.40(a)](/cfr/21/610.40.md?p=a) and [(b)](/cfr/21/610.40.md?p=b), then you must include in the device labeling a statement of warning indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified relevant transfusion-transmitted infection(s).
- (b) FDA may approve an exception or alternative to the statement of warning required in [paragraph (a)](#a) of this section based on evidence that the reactivity of the human blood or blood component in the medical device presents no significant health risk through use of the medical device.

## Notes

### Amendments

[66 FR 31164, June 11, 2001, as amended at 80 FR 29897, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

### Amendments

[66 FR 31164, June 11, 2001, as amended at 80 FR 29897, May 22, 2015]