[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.65]

[Page 67-68]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
                          Subpart D--Exemptions
 
Sec. 807.65  Exemptions for device establishments.


    The following classes of persons are exempt from registration in 
accordance with Sec. 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

[[Page 68]]

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]