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Conformance with the FDA's rules as they apply to the manufacture of hyperbaric chambers is usually not difficult in a technical sense. However, it does require a commitment to procedural controls that can be difficult to sustain, especially in small companies.

"Labeling" is interpreted by the FDA to mean just about everything the manufacturer says about what the device can be used for and how it can be used. As with oxygen itself, claims for applications outside those listed in the UHMS HBO Report can lead to unwelcome consequences.

Adultered Devices are prohibited. Adultered devices are devices:

built in an un-registered establishment
built without a cleared 510(k) Pre-Market Notification
altered or otherwise not built in accordance with the approved design

Modifications to Existing Chambers: If you are planning a modification of a chamber owned by your facility, you should check out the regulatory implications before proceeding. Under current FDA policy guidelines, an organization does not have to be registered with the FDA as a reconditioner/rebuilder to do major repair/restoration work on a hyperbaric chamber owned by others. However, it must be registered if it is doing similar work on a chamber to which it has acquired ownership. Normal maintenance and simple repairs are not of interest to the FDA. However, any modifications that may effect function or performance are likely to be.

Avoidance of Appearance of Endorsement of Products. Manufacturers are not permitted to refer to their FDA 510(k) Pre-market Notifications nor resulting FDA Clearances in advertising or in any published literature. However, a manufacturer can respond to a request from a potential customer regarding whether or not a manufacturer has a cleared 510(k) Pre-market Notification for a specific device.

How to Find Out if a Particular Hyperbaric Chamber Has Been Cleared by the FDA. The simplest way is to ask the manufacturer. Alternatively, you can put the Internet to work for you. Hyperbaric chambers are categorized by the FDA under the general heading of anesthesiology products. The address for FDA 510(k) information is:

http://www.fda.gov/cdrh/510khome.html (Changed in 1999, see below)

Once there, click on the button for "Search the releasable 510k data base" and select the category "anesthesiology". You can then search by any number of methods, including manufacturer, product type, etc. The FDA product code for hyperbaric chambers is 73 CBF.