C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart G—General Hospital and Personal Use Miscellaneous Devices

21 C.F.R. § 880.6230

Tongue depressor

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(a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025]
Notes of Decisions
Cited in 3 cases, 1995–2007 · leading case: Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324 (4th Cir. 1997).
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Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324 (4th Cir. 1997). “§ 360c(a)(1)(A); 21 C.F.R. § 880.6230 (1996). Class II devices, such as bone-conduction hearing aids, for which “general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device,” are subject to special controls.”
Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995). “§ 360e(a)(l)(A); 21 C.F.R. § 880.6230 (1994). Class II devices, such as bone-conduction hearing aids, for which “general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device,” are subject to special controls.”
Rattay v. Medtronic, Inc., 482 F. Supp. 2d 746 (N.D.W. Va. 2007). “§ 360c (a)(1)(B); 21 C.F.R. § 874.3300 (1996).”
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