By Jeff Shuren MD JD – FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff…
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The thought leaders in our community are good about sharing their thoughts on the issues of today. Here are the top read and shared guest posts of January that we think deserve sharing again.
By Jeffrey Shuren MD, JD – Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world.
By Scott Gottlieb MD & Jeffrey Shuren, MD JD – Recently, the Food and Drug Administration has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
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.
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.