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Devices

FDA’s 510(k) Recommendations

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The FDA’s 510(k) medical device approval process has been criticized for requiring too little data on potentially harmful devices. The FDA undertook a review of the process and has issued a description of initial steps it plans to take, which the industry seems to view as acceptable.

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State of the Medical Device Industry

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Although health care products like drugs and medical devices get blamed for much of the cost in our system, they also often provide better care for patients and the companies making these products are an important part of our economy. A new report summarizes the state of the medical device industry.

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