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.

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NCHR comments on FDA’s Framework for Real-World Evidence Program

February 5, 2019. FDA needs to maintain high standards for evidence of effectiveness and safety whether the source of the data is from traditional clinical trials or RWE. Double-blind, randomized clinical trials remain the gold standard, and along with other types of well-controlled trials (including those that generate RWE), provide information that observational studies cannot. RWE should supplement rather than replace traditional, randomized and blinded controlled clinical trials except in situations where such traditional clinical trials are not possible.

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