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:
(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