Addressing Medical Device Challenges

FDA https://www.fda.gov, is participating in several new collaborative communities aimed at addressing challenges in patient healthcare. The collaboratives enable private and public sector representatives of the community to work together on medical device challenges.

FDA currently participates in 12 collaborative communities which are established, managed, and controlled by external stakeholders. Collectively, these communities are charting paths to accelerate and address regulatory science and other knowledge gaps to aid in medical device review and oversight.

Collaborative communities are convened by interested stakeholders and may exist indefinitely to tackle challenges with broad impacts. FDA does not establish, lead or operate collaborative communities nor are collaborative communities intended to advise FDA. FDA, however, may participate in the community to contribute knowledge and discussion on public health challenges and solutions.

The most recent collaborations focus on medical device development and product quality, understanding of valvular heart disease, reducing rates of intended self-injury and suicidal acts by people with diabetes, and strategies needed to increase the awareness, understanding and participation of racial and ethnic minorities in the medical technology industry.

Some of the Collaborative Communities include:

  • Collaborative Community on Ophthalmic Imaging
  • Case for Quality Collaborative Community
  • Wound Care Collaborative Community
  • Pathology Innovation Collaborative Community
  • Digital Health Measurement Collaborative Community

 

“The number of collaborative communities has continued to grow, showing that amidst the backdrop of the COVID-19 pandemic, many remain dedicated to the idea that they can better achieve common outcomes, solve shared challenges, and leverage collective opportunities to improve public health,” said Michell Tarver, M.D, PhD, Director of the Office of Strategic Partnerships and Technology Innovation in FDA’s Center for Devices and Radiological Health.