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June 28, 1995

Medical Devices: Significant vs Nonsignificant Risk

Author Affiliations

St Luke's Professional Care Center Chesterfield, Mo

JAMA. 1995;273(24):1906. doi:10.1001/jama.1995.03520480024028

To the Editor.  —I read with interest the article by Dr Sherertz and Mr Streed.1 However, I disagree with the authors' conclusion. I believe much of the problem is with the FDA and not with the manufacturers. The FDA makes it difficult for a manufacturer to make even small alterations in a product. Additional expensive studies can be required even though changes are minimal. Some companies have started restricting their products from being used for medical purposes because of fears of litigation.The FDA's attitude is that a medical device should have no risk. While this may be a very noble goal, is it achievable? Should not physicians, in discussions with their patients, be the ones to decide on an appropriate level of risk? I would hope that in the future the FDA can take a more realistic approach toward risk and safety. When the government becomes too restrictive,

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