Digital birth control apps are becoming more common. The FDA has now cleared two apps: Natural Cycles and Clue for preventing pregnancy. Read more about why these apps are unreliable for women looking to avoid pregnancy.
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NCHR Comment on Management of Cybersecurity in Medical Devices
March 18, 2019. We support FDA’s efforts to update their approach to address growing concerns about cybersecurity risks in medical devices through the premarket submission process. Software and medical devices have become increasingly interconnected and vulnerable to network-related cybersecurity breaches, which puts patients at risk. We have several concerns and recommendations to improve the updated guidance.
Read More »NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance
December 13, 2018. The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices. We strongly oppose it for that reason.
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