HealthIT Answers November 8, 2021
By Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH, FDA
At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices. This includes our responsibility to review premarket submissions for certain new medical devices and modifications to devices currently on the market. As part of this ongoing work, the FDA continues to take steps to strengthen the premarket review program and make it more efficient, consistent, and predictable.
While the pandemic has challenged CDRH in many ways, it has also...