[Federal Register Volume 68, Number 159 (Monday, August 18, 2003)]
[Rules and Regulations]
[Page 49351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-55524]


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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