Since the implementation of the 1976 Medical Device Amendments, the process for obtaining approval to market a medical device through Food and Drug Administration has evolved into a fairly routine process for most medical devices. The process is much more complex, however, for medical laser products. My presentation will address the FDA approval process that a medical laser manufacturer must go through before it can market its product to the medical community.
Topics
Biomedical equipment
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© 1987 Laser Institute of America.
1987
Laser Institute of America
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