cfr_sections: 21:21:8.0.1.1.32.4.1.15

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section_id	title_number	title_name	chapter	subchapter	part_number	part_name	subpart	subpart_name	section_number	section_heading	agency	authority	source_citation	amendment_citations	full_text
21:21:8.0.1.1.32.4.1.15	21	Food and Drugs	I	H	890	PART 890—PHYSICAL MEDICINE DEVICES	D	Subpart D—Physical Medicine Prosthetic Devices	890.3520	§ 890.3520 Plinth.	FDA	21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.	48 FR 53047, Nov. 23, 1983, unless otherwise noted.	[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025]	(a) Identification. A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination. (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.