[abstract] FDA'S ROLE IN HYPERBARIC MEDICINE.

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[abstract] FDA'S ROLE IN HYPERBARIC MEDICINE.

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Title: [abstract] FDA'S ROLE IN HYPERBARIC MEDICINE.
Author: Foreman, C
Abstract: Since the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act of 1976 and its subsequent amendments (Safe Medical Devices Act of 1990 and the Food and Drug Modernization Act of 1997), the FDA has regulated the marketing of hyperbaric chambers as Class II medical devices. These requirements establish the safety and effectiveness of hyperbaric chambers compared to devices already on the market, their intended uses, and further classifies them as prescription devices. Due to the increased activity within the field of hyperbaric medicine, the FDA has been receiving increased numbers of premarket submissions as well as an increase in postmarket compliance activities related to the marketing and promotion of hyperbaric medicine. This presentation is intended to educate the hyperbaric medical community on the requirements for hyperbaric chambers by discussing the premarket review process; compliance issues such as off-label use; how physicians and facilities can advertise for hyperbaric therapy; what the rules are for Internet advertising; and, what happens when companies, facilities or medical professionals are found to be in violation of the regulations.
Description: Undersea and Hyperbaric Medical Society, Inc. (http://www.uhms.org )
URI: http://archive.rubicon-foundation.org/1045
Date: 2001

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  • UHMS Meeting Abstracts
    This is a collection of the published abstracts from the Undersea and Hyperbaric Medical Society (UHMS) annual meetings.

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