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Improving medical device regulation in the United States

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In a recent New England Journal of Medicine article, Stanford health economist Alan Garber, MD, PhD, examines the shortcomings of the Food and Drug Administration process for approving medical devices and he looks at solutions to make regulations more effective.

In addition to strengthening the preapproval process for devices, Garber advocates a more comprehensive post-marketing surveillance system. He writes:

Medical devices hold tremendous potential for both good and harm. A modernized and more appropriate approach to their regulation should not be limited to better preapproval evaluation. The payoff from increased investments in postapproval studies would be substantial. The collection of postapproval data can be facilitated through the pooling of data from electronic health records, which offers the opportunity for researchers and regulators to learn from the experience of large numbers of patients, with far more extensive clinical detail than has been available from observational databases. Longer follow-up periods would enable the FDA to detect delayed benefits and harms. And studies based on real-world experience would do a better job of evaluating effectiveness for typical patients. This is the right time to institute a more comprehensive approach to the postapproval monitoring and analysis of the safety and effectiveness of medical devices.

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