Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

National Center for Health Research Public Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. We are writing on behalf of five […]

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NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data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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