21 CFR 890.3700 — System, Communication, Non-Powered

Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3700

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.

Classification Rationale

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.

Product Codes