23 January 2018
Dear Colleague,
Through this announcement we wanted to share with you that the Food and Drug Administration (FDA) will be hosting a public workshop titled “Orthopaedic SMART Devices” on Monday, April 30th, 2018, at the FDA campus in White Oak, Maryland. FDA understands that Sensing, Measuring, and Advanced Reporting Technologies (SMART) will play a role in the future of orthopedics and have the potential to greatly benefit the public. We would like to gain perspective on future technologies so that we can allocate our resources appropriately and better develop our review policies to advance our mission of protecting and promoting the public health. This will ensure FDA can provide the public with the most up to date, safe, and effective medical devices. In addition, we would like to provide outside stakeholders, including industry and healthcare professionals, with our current and evolving thinking on Digital Health technologies, available regulatory pathways, and types of supporting data.
The four topic areas that will be covered at the inaugural workshop are:
- Engineering/Technology – In this session we will introduce orthopaedic sensor technologies and cover the current state of research and industry adoption. We will also explore future applications of this technology.
- Clinical/Patient Perspective – In this session we will cover the importance and potential utility of these technologies for clinicians and patients. Considerations for adopting these new technologies into existing healthcare paradigms will also be discussed.
- Cybersecurity – In this session we will cover current cybersecurity issues and considerations. Also, FDA’s cybersecurity considerations and guidance documents will be presented.
- Regulatory Considerations– This session will discuss FDA’s current and evolving thinking on Digital Health, clinical study considerations, including the role of real-world evidence, relevant guidance documents, and evidence generation related to Orthopaedic SMART Devices.
We will use the workshop to establish a collaborative dialogue between outside stakeholders and government regulators, such that all parties can share their perspectives and benefit from an exchange of information. At the conclusion of the workshop, we hope that FDA will have a better understanding of these technologies and their future. Similarly, we hope that outside stakeholders will have a better understanding of how these devices may be regulated. If you have any questions and / or comments, please, contact Andrew Baumann, PhD in the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health at 301-796-2508 or via email at andrew.baumann@fda.hhs.gov
Sincerely,
The FDA organizing committee