In April of this year, the FDA released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which described recent actions we’ve taken to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices. We continue to modernize our approach to device safety. After carefully considering public feedback, we’ll be announcing in a series of updates several important new actions that will help the FDA continue to enhance our nationwide post-market surveillance system; address new safety concerns that emerge once a device is on the market; and encourage innovations that lead to safer medical devices.
Today, we’re focusing on several key actions we’re taking to create a more robust medical device safety net for patients through better data. We’re also announcing several new steps related to important health devices that impact women, including surgical mesh for transvaginal surgical repair.
Next week, we’ll announce additional actions aimed at fundamentally modernizing the process for medical device review, particularly as it relates to the 510(k) process.
At the heart of the new actions that we’re taking today, we’re announcing that we’re setting an important and ambitious new goal when it comes to device safety: Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.
We also are providing updates on new funding for the National Evaluation System for health Technology (NEST), our launch of pilot studies to demonstrate how NEST would be implemented and our advances in developing a women’s health coordinated registry network to help strengthen NEST.
In thinking about the regulation of medical devices, it’s important to consider the vast and diverse medical device landscape. The FDA regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide. These products provide immense and often life-saving benefits to millions of patients. On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day after carefully determining -- based on valid scientific evidence -- that the devices are safe and effective. These decisions take into consideration whether the benefits of the devices outweigh their risks to patients.
