NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019. Patient perspectives and experience are important considerations for medical product development and regulation.  Patients, caregivers, and patient and consumer groups can provide a valuable resource for product developers and the FDA.  Transparency in how the FDA evaluates and uses proposed draft guidances as well as who and how they are developed will be important if they are to provide meaningful and accurate information about patients.

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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.

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