21 CFR 876.5920 - Protective garment for incontinence.
(a)Identification. A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
(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 § 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.
Title 21 published on 2015-12-03.
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.