FDA Clearance and UHMS Approval
The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and
effectiveness of drugs, medical devices, and many other products.
Federal law authorizes the FDA to regulate the marketing of hyperbaric chambers as Class II medical devices.
regulations require valid scientific evidence that a Class II device is safe and effective for its intended use.
The intended use of a device includes the clinical indications (the specific diseases and conditions) it will be
used to treat.
Applications to the FDA by manufacturers of hard-walled hyperbaric chambers reference the
Report of the Hyperbaric Oxygen Therapy Committee (HOTC) of the
Undersea and Hyperbaric Medical Society (UHMS)
on approved indications. (Manufacturers of inflatable “mild hyperbaric chambers” reference the prior approval of a device
known as the Gamow Bag.)
The Report of the Hyperbaric Oxygen Therapy Committee effectively determines the intended use of hyperbaric
chambers legally marketed in the United States. (The intended use of mild hyperbaric chambers referencing the Gamow Bag as a
predicate device is limited to treatment of Acute Mountain Sickness.)
The Hyperbaric Oxygen Therapy Committee evaluates valid scientific evidence
regarding the safety and effectiveness of hyperbaric oxygen therapy for clinical indications to determine which merit approval.
Regulation of medical device manufacturers is the responsibility of the FDA’s
Center for Devices and Radiological Health
(CRDH). All manufacturers of medical devices must be registered with the CDRH. The CRDH
can be used to find information about manufacturers and determine the clearance or approval status of their devices.
As makers of
Class II medical devices,
hyperbaric chamber manufacturers must obtain the FDA’s approval to market their
products for the treatment of specific diseases and conditions, or clinical indications. This approval process is known as
510(k) clearance. Section 510(k) of the Food, Drug and Cosmetic Act requires each manufacturer to demonstrate that its device
is substantially equivalent to a predicate device already on the market. Substantial equivalence means the new device is at
least as safe and effective as the predicate.
Manufacturers of hard-walled hyperbaric chambers, citing earlier monoplace and multiplace chambers as predicates, generally
receive 510(k) clearance to treat the full range of clinical indications approved by the UHMS. Manufacturers of soft-sided
mild hyperbaric chambers, citing the earlier approval of the Gamow Bag as a predicate, receive 510(k) clearance for
Acute Mountain Sickness
Before clearance is granted the manufacturer must demonstrate that the device is
in accordance with FDA labeling regulations. Labeling is defined to include virtually all advertising by device manufacturers.
To maintain clearance, manufacturers must also comply with FDA requirements governing manufacturing processes and documentation.
Other federal regulations and standards apply to specific aspects of the design and operation of hyperbaric chambers.
The FDA recognizes two consensus standards that apply to the construction and operation of hyperbaric chambers. A hyperbaric
chamber manufacturer must demonstrate to the FDA that its devices are in compliance with these standards:
American Society of Mechanical Engineers (ASME) Standard PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy
National Fire Prevention Association (NFPA) Code 99, Standard for Healthcare Facilities Chapter 20 – Hyperbaric Facilities
Do not accept hyperbaric oxygen therapy in a medical device that is not cleared by the FDA and labeled by the American Society of
Mechanical Engineers as a pressure vessel for human occupancy (ASME PVHO-1).
Undersea and Hyperbaric Medical Society
(UHMS) is a nonprofit association of physicians and scientists formed in 1967. Its mission includes providing information and
support for hyperbaric medical research and patient treatment with hyperbaric oxygen, improving scientific knowledge of
hyperbaric oxygen therapy, and improving standards of patient care and operational safety.
The UHMS certifies doctors in Undersea and Hyperbaric Medicine (UMS). It also accredits select treatment centers that have
demonstrated the highest levels of facility safety and effectiveness.
The Hyperbaric Oxygen Therapy Committee of the UHMS is composed of doctors who evaluate the results of clinical trials and
other scientific evidence according to a hierarchy adapted from the
Oxford Centre for Evidence-Based Medicine.
The FDA relies on the Undersea and Hyperbaric Medical Society for guidance on the safety and effectiveness of hyperbaric
oxygen therapy for specific diseases and conditions.
To date the UHMS Hyperbaric Oxygen Therapy Committee has recognized the following clinical indications:
- Air or Gas Embolism
- Carbon Monoxide Poisoning
- Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- Clostridial Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and Other Acute Traumatic Ischemias
- Decompression Sickness
- Central Retinal Artery Occlusion
- Sensorineural Hearing Loss
- Enhancement of Healing In Selected Problem Wounds
- Severe Anemia
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Compromised Grafts and Flaps
- Acute Thermal Burn Injury
Diseases and Conditions
section for links to additional resources and detailed information about each of these UHMS-approved clinical indications.
Read more about the UHMS approval process in
Hyperbaric Oxygen Therapy Indications (12th Edition),
available for purchase on the UHMS website.
Implications for insurance reimbursement
The UHMS also provides guidance for the Centers for Medicare and Medicaid Services (CMS) and for private health insurance
carriers in the financial reimbursement of hyperbaric oxygen therapy. CMS and private insurers generally reimburse the cost
of hyperbaric oxygen therapy for patients who receive treatment for clinical indications approved by the UHMS in hyperbaric
chambers cleared by the FDA.
Monoplace and multiplace hyperbaric chambers that receive FDA 510(k) clearance are “labeled” for the treatment of
UHMS-approved clinical indications only.
Licensed physicians and healthcare institutions may legally use an FDA-cleared hyperbaric chamber to treat many unapproved
or “off-label” diseases and conditions as well. It is illegal to promote or advertise such uses.
Patients and referring physicians should note that, for these off-label or investigational uses of hyperbaric oxygen therapy,
the hyperbaric medical community has not yet established safe and effective treatment protocols and dosages (pressure,
One may reasonably question the safety and effectiveness of hyperbaric oxygen therapy for the treatment of diseases and
conditions that have not been approved by the UHMS.
Diseases and Conditions
section provides links to additional resources and detailed information about several of the most common off-label uses of hyperbaric oxygen therapy.
Each page in our Diseases and Conditions section includes our
an at-a-glance summary of the state of clinical evidence for the treatment of the disease or condition with hyperbaric oxygen therapy.
Physicians providing off-label HBOT should clearly and cheerfully answer your questions about the medical devices employed
and about the current state of the clinical evidence and insurance reimbursement for your disease or condition.
Never pay to participate in a clinical trial.
Always get a physician prescription for HBOT, no matter whether your disease or condition is UHMS-approved or your therapy