Legal Use Of RHP Ozone Therapy
FDA Response To a Legal Question
On Non- Approved Medical Units
You are correct that as a licensed practitioner your are exempted from
the medical device requirements as long as the item is used solely in
your practice. As soon as you expand beyond your own practice the
exemption provided by 21 CFR 807.65(d) would no longer apply.
I appreciate this opportunity to provide assistance,
Mr Geoffrey S Clark, ConsumerSafetyOfficer
* Room 4364 <> WO 66
10903 New Hampshire Ave
Silver Spring, MD 20993 – United States of America
* – firstname.lastname@example.org
* – 800.638.2041×65854 or 301.796.5854
7 – 301.847.8149 – please use cover page
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H–MEDICAL DEVICES
|Code of Federal Regulations]|
|[Title 21, Volume 8]|
|[Revised as of April 1, 2008]|
Sec. 807.65 Exemptions for device establishments.
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.
(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]
In addition two of our units have the capacity to perform something called SAFE which stands for Simple Access Fluid Extraction.This method is recognized and FDA approved, see Aquapheresis here http://en.wikipedia.org/wiki/Aquapheresis , Here http://www.sciencedaily.com/videos/2008/0409-saving_hearts.htm, and here http://voices.yahoo.com/aquapheresis-method-reducing-8203635.html . There are many more links if you type in aquapherisis in www.google.com .