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Article
June 28, 1995

Medical Devices: Significant vs Nonsignificant Risk-Reply

Author Affiliations

Bowman Gray School of Medicine
North Carolina Baptist Hospital Winston-Salem, NC

JAMA. 1995;273(24):1906-1907. doi:10.1001/jama.1995.03520480024029
Abstract

In Reply.  —We are pleased that Ms Segal's IRB is knowledgeable about the issues discussed in our article. The fact that it was inconceivable to her that our problem developed is irrelevant. The reason the article was written was that it did happen to us and that a survey of other similar institutions demonstrated to us that it could happen to others as well. Perhaps the process by which IRBs become aware of relevant FDA regulations needs to be more standardized so that such disparities in knowledge between IRBs will not occur.Dr Huffaker feels that the FDA makes it too difficult for manufacturers to modify medical devices and his implication is that we agree with them. We did not actually address the level of FDA regulation that should exist to oversee the modification of medical devices. We focused on the lack of understanding of the medical community related to

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