This week FDA released a statement about its action plan for further improving device and patient safety. Sent on behalf of FDA Commissioner Scott Gottlieb, M.D. and CDRH Director Jeff Shuren, M.D., the agency’s focus will be on improving the postmarket surveillance system, addressing issues that come up once a device is on the market and promoting innovations that can make devices safer. The actions that the agency is targeting came out of public feedback it received after releasing its Medical Device Safety Action Plan in April.

“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,” stated Gottlieb and Shuren, adding that next week FDA will be announcing what it will be doing to modernize the medical device review process, especially related to 510(k)s.

“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.” – Scott Gottlieb, M.D. and Jeff Shuren, M.D.

Gottlieb and Shuren highlighted the following initiatives:

• Improving access to “robust and timely data”, including postmarket data and real-world evidence
• Investment in new tools, policies and resources that improve postmarket safety
• Committing new resources to the new national system for gathering real world evidence (NEST) to “advance a more rapid build-out” of the system. This includes an allocation of $3 million in agency funding. In addition, a $46 million request was included in the President’s FY 2019 budget for NEST.
• Women’s health is a priority. There will be a focus on clinical questions that are related to female-specific devices and therapies, such as those that treat uterine fibroids, pelvic floor disorder and long-acting reversible contraception.
  • Launch of the National Breast Implant Registry in September 2018 to help FDA evaluate data from providers about patients who have implants and monitor any risks associated with the devices
  • Continued monitoring of energy-based devices for vaginal rejuvenation, as they may be inappropriately marketed to women
  • On February 12, 2019, FDA will convene an advisory committee meeting to discuss the safety and effectiveness of surgical mesh for transvaginal pelvic organ prolapse repair