C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES › Subpart A—General

21 C.F.R. § 860.1

Scope

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(a) This part implements sections 513, 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act with respect to the classification and reclassification of devices intended for human use.

(b) This part prescribes the criteria and procedures to be used by advisory committees, including classification panels, where applicable, in making their recommendations, and by the Commissioner in making the Commissioner's determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, importers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also describes the type of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to advisory committees, including classification panels, or to the Commissioner in connection with classification and reclassification proceedings, will be available to the public.

[43 FR 32993, July 28, 1978, as amended at 86 FR 54846, Oct. 5, 2021]
Notes of Decisions
Cited in 2 cases, 1981–1990 · leading case: Teich v. Food & Drug Admin., 751 F. Supp. 243 (D.D.C. 1990).
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Teich v. Food & Drug Admin., 751 F. Supp. 243 (D.D.C. 1990). “The FDA is already required to obtain much of this information, such as the animal studies, during the classification of devices under 21 C.F.R. § 860.1 (a). In fact, the agency previously obtained most of the animal studies at issue here through a mandatory submission by Dow…”
Postscript Enter., Inc. v. Whaley, 658 F.2d 1249 (8th Cir. 1981). “has begun to regulate the quality for some items in this area, see 21 C.F.R. § 860.1 (1980), and that quality control is not furthered by this limitation.”
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