Medical devices: Ophthalmic devices— Headband mirror; CFR correction,

[Federal Register: August 18, 2003 (Volume 68, Number 159)]

[Rules and Regulations]

[Page 49351]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr18au03-17]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

Ophthalmic Devices

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2003, in Sec. 886.1500, on page 456, paragraph (b) is added to read as follows:

Sec. 886.1500 Headband mirror.

* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in Sec. 886.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180, with respect to general requirements concerning records, and Sec. 820.198, with respect to complaint files.

[FR Doc. 03-55524 Filed 8-15-03; 8:45 am]

BILLING CODE 1505-01-D