C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES › Subpart D—Exemptions

21 C.F.R. § 807.65

Exemptions for device establishments

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The following classes of persons are exempt from registration in accordance with § 807.20 under the provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or because the Commissioner of Food and Drugs has found, under section 510(g)(5) of the act, that such registration is not necessary for the protection of the public health. The exemptions in paragraphs (d), (e), (f), and (i) of this section are limited to those classes of persons located in any State as defined in section 201(a)(1) of the act.

(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part.

(b) A manufacturer of devices to be used solely for veterinary purposes.

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.

(g) [Reserved]

(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.

[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160, Nov. 27, 2001]
Notes of Decisions
Cited in 4 cases, 1992–2019 · leading case: Lamontagne v. EI Du Pont De Nemours & Co., 834 F. Supp. 576 (D. Conn. 1993).
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Lamontagne v. EI Du Pont De Nemours & Co., 834 F. Supp. 576 (D. Conn. 1993). · cites it 2× “,” 21 C.F.R. § 807.65 (1992), “because the Commissioner has found, under section 510(g)(4) of the act [ 21 U.”
Freed v. St. Jude Med., Inc., 364 F. Supp. 3d 343 (D. Del. 2019). “The Court notes that the FAC does now include an allegation stating that 21 C.F.R. § 807.65 exempts manufacturers of raw materials or components from FDA regulation, and that upon information and belief, "the battery used in the SCS device is a component part manufactured by…”
Clinical Reference Lab'y, Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992). · cites it 3× “Although 21 C.F.R. § 807.65 (c) and (i) provide exemptions for certain devices, they are merely exemptions from the premarket registration requirement.”
Doris Jacobs & Phillip Jacobs (93-4144) Patricia A. Adelmann (93-5978/6561) v. E.I. Du Pont De Nemours & Co., 67 F.3d 1219 (6th Cir. 1995). “” See 21 C.F.R. § 807.65 . 34 These registration requirements include supplying the FDA with a copy of the warnings and labelling that accompany the final medical device.”
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