By Jeff Shuren MD JD & William Maisel MD – Since the beginning of the COVID-19 pandemic, the demand for medical devices has far exceeded anything we have seen in previous public health emergencies. The FDA’s Center for Devices and Radiological Health has worked to address these unprecedented demands…
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By Jeff Shuren MD JD & William Maisel MD MPH – At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices.
By Jeff Shuren MD JD & Daniel Caños PhD MPH – Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation.
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…
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.