21 CFR 890.3700
§ 890.3700 Nonpowered communication system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3700, § 890.3700 Nonpowered communication system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91191
- Permanent ID
ys:prov:91191@1- SHA-256
180f7417ef88fe735a796b07213cae71709faca6940541d3bd6c310b4e889781
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Full text
(a) Identification. A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.
(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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.