68 FR 159 pg. 49351 - Ophthalmic Devices
Type: RULEVolume: 68Number: 159Page: 49351
FR document: [FR Doc. 03-55524 Filed 8-15-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 § 886.1500, on page 456, paragraph (b) is added to read as follows:
§ 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 § 886.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[FR Doc. 03-55524 Filed 8-15-03; 8:45 am]
BILLING CODE 1505-01-D