By Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., & Melinda K. Plaisier, M.S.W. – Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality.
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By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.
By Nina L. Hunter PhD & Robert M. Califf MD – Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.
By Taha Kass-Hout, Roselie A. Bright & Ann Ferriter – OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle.
By Taha A. Kass-Hout, M.D., M.S., & David Litwack, Ph.D. – FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in the human genome, we don’t understand the role that most of these variants play in health or disease.
By Jeffrey Shuren – We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.
By Bakul Patel & Jeffrey Shuren – Engaged patients! Quantified self! Lifelogging! These buzzwords describe an exciting technology-based, patient-centered approach to living healthier. The myriad of systems that record, share, and use personal and health data have become a significant help for many of us by putting information at our fingertips to use when and where we think it might help promote a healthy lifestyle. The ultimate goal of these products is to improve our quality of life.
By Owen Faris & Jeffrey Shuren – At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.
Collectively EHRs Represent Huge Amounts of Data By Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research Not long ago, electronic health records…