Content by Scott Gottlieb, Jeffrey Shuren
New Steps to Facilitate Medical Device InnovationThe least burdensome approach
Tue, 02/06/2018 - 12:01
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we announced our intention to propose an…
When Inspections and Regulations Leave Quality Lacking, Try ThisA Case for Quality is changing medical device manufacturers focus and FDA’s approach
Wed, 12/02/2015 - 16:33
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified…
A CDRH Priority: Clinical Trials in the United StatesStriving to get U.S. patients fast access to safe and effective medical devices
Mon, 02/09/2015 - 16:46
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 also present the greatest…
Meet MAUDENew interface provides access to FDA database of medical device reports
Tue, 09/02/2014 - 16:09
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential,…