Food and Drug Administration (FDA) regulates what pharmaceuticals are allowed on the market and what claims of effectiveness the sellers of those pharmaceuticals are allowed to make. It does the same thing for what medical devices are allowed on the market and what claims of effectiveness the vendors are permitted to make. The scope of authority is in two areas: Drugs: Safety, Effectiveness, and Labeling and Medical Devices: Safety, Effectiveness, and Labeling.
The FDA classifies oxygen as a drug. As a drug, oxygen can be administered only on the order of a physician. The main concern of the FDA regarding the use of HBOT is the claims that are made for its effectiveness. At this time the FDA recognizes the indications for HBO in the UHMS document: “Hyperbaric Oxygen Therapy: A Committee Report.” (UHMS HBO Report), 2008.
Advertizing claims not included in this report may subject a manufacturer or facility to a visit from the FDA. The FDA does not regulate the practice of medicine. A licensed physician is free to use any combination of approved pharmaceuticals and cleared medical devices desired; the doctor’s activities are regulated by the state board of medicine.
Hyperbaric chambers are medical devices and are subject to the FDA’s rules for Class II medical devices. A manufacturer is required to have a “pre-market clearance” from the FDA before the device can be legally marketed or commercially distributed. This clearance is named a “510(k)” after the form that must be submitted by the manufacturer. The most time-efficient way to find out if a manufacturer has a pre-market clearance is to access the FDA website. Visit www.fda.gov/scripts/cfpmn/search.cfm. Select Anesthesiology, Product Code is CBF (the code for hyperbaric products) and Search.
The FDA can impose severe penalties on companies and individuals that sell uncleared devices. In the case of an accident, the operators of uncleared devices may find that they are denied insurance coverage. Clinical hyperbaric chambers are defined by the NFPA as Class A (multiplace) and Class B (monoplace). In multiplace chambers, one or more patients receive O2 by mask, hood, or endothelial tube while pressurized in the chamber. In monoplace chambers, a single patient may be pressurized with air, or with pure O2.
All classes of medical devices are subject to the FDA’s Good Manufacturing Practice (GMP) regulations. The FDA GMP rules are very similar to international quality assurance regulations (ISO 9000, ISO 9001, etc.)
The main requirements for GMP are:
- An established design for the product
- Production in accordance with the design
- Testing to confirm performance in accordance with design requirements
- Receipt control and inspections of incoming materials
- Established procedures for resolving problems and customer complaints
- Production documentation sufficient to maintain accountability and confirm requirements are being met
- Manufacturing establishment and products must be registered annually with the FDA
They are those in the Medicare regulations.
(Application info from 2002)
BARA-MED Acrylic Monoplace Hyperbaric Chamber, Environmental Tectonics Corporation (ETC), BioMedical Systems Group, 125 James Way, Southhampton, PA 18966-3877,
Contact Mr. Michael W. Allen
Classification Name: 21 C.F.R. 868.5470 (also the regulation number)
Pressures not exceeding 3 ATA
Designed and manufactured in accordance with the applicable sections of:
ASME Boiler and Pressure Vessel Code, Section VIII, Rules for Construction of Pressure Vessels, Division 1, 1998 Edition
ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy, 1997 Edition.
Department of Health and Human Services—FDA
Regulation Number: 868.5470
Regulation Name: Hyperbaric Chamber
Regulation Class: II (two)
Section 519 (k): premarket notification of intent to market the device. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. This concern exists with devices of this type. To address this concern, in accordance with Section 513(i)(1)(E), labeling this device for any specific indication for use, labeling instructions, instructions for use (including company sponsored training programs), as well as any bibliography that accompanies your device, is limited to the 14 UHMS and Medicare-approved conditions.
Other additional regulations: Code of Federal Regulation, Title 21, Parts 800-898. In additionally, the FDA may publish further announcements concerning this device in the Federal Register.
Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
For specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), contact the Office of Compliance at (301) 594-4646.
For questions on the promotion and advertising of the device, contact the Office of Compliance at (301) 594-4639. Note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97).
Other general information on manufacturers’ responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at 800 638 2041 or 301 443 6597 or at its Internet address http://www.fda.gov/cdrh. (Contact for this correspondence was with Bernard E. Statland, Director of Office of Device Evaluation, Center for Devices and Radiological Health.)