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FDA looks into the risk of medical devices being hacked
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FDA loophole led to years of unsafe medical devices
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This PSA, issued shortly before the Safe Medical Devices Act of 1990, features Yorick, who was created by FDA engineers who began attaching medical devices to a skeleton. Yorick became a favorite teaching tool. The 1990 Act amended the Federal Food, Drug, and Cosmetic Act to require medical device user facilities, such as ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities, to report all incidents in which a medical device or user error may have caused
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FDA approved the 50th biosimilar and released the new Biosimilars Action Plan (BAP). Since FDA’s biosimilars program started, the agency has contributed to the growth of biosimilar adoption and the increasing availability of therapeutic options for patients who face increasing costs and restrictions to access much needed medications. FDA has approved biosimilars to treat a wide range of conditions such as diabetes, skin conditions, bowel disorders, and more. These treatment options can give pati
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Medical Devices Harm Patients Worldwide As Governments Fail On Safety
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