21 C.F.R. § 892.1

Scope

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(a) This part sets forth the classification of radiology devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a radiology device that has two or more types of uses (e.g., use both as a diagnostic device and a therapeutic device) is listed in one subpart only.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of this title 21, unless otherwise noted.

(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[53 FR 1567, Jan. 20, 1988, as amended at 73 FR 40969, July 17, 2008; 78 FR 18233, Mar. 26, 2013]

Notes of Decisions

Cited in 1 case, 1992–1992 · leading case: Clinical Reference Lab'y, Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992).

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Clinical Reference Lab'y, Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992). “§ 821 (h)(2) (1988) (emphasis added); see also 21 C.F.R. § 892.1 (c) (1991) (X-ray machines are devices under the Act, whether used for diagnostic purposes or therapeutic purposes).”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.