FDA discussion paper on Robotically-Assisted Surgical Devices

FDA released yesterday a discussion paper on Robotically-Assisted Surgical Devices (RASD)
to outline topics related to the design, development, evaluation and regulation of surgical robots, facilitating the dialogue at the upcoming FDA Public Workshop to be held at the White Oak Campus in Silver Spring, MD on July 27 & 28, 2015.

It articulates some very relevant questions regarding the harmonization of the field, well aligned with the work we do at the ISO/IEC TC 184 JWG 35 (we will comment on it later):

"We identified the following challenges and opportunities that may be considered when striving to optimize patient care through the use of RASD:

• What are the key fundamental technological and performance characteristics for a new RASD platform? What are the key fundamental technological and performance characteristics for iterative changes to marketed RASD platforms?
• How should interoperability among RASD platforms and other medical devices intended for use with those platforms (including those from different manufacturers) be assessed? What sort of evidence, if any, should be provided? Should interoperability be promoted?
• When are the considerations when distinguishing between “general” use indications and “specific” indications for RASD? Under what circumstances are additional data needed?
• What is the role of training and simulation during the premarket evaluation as a means for ensuring device usability and mitigating risk? How should it be assessed?
• How can collaboration among all stakeholders be promoted to improve and create data sources that can be efficiently leveraged for multiple purposes."

Direct link to the Discussion Paper; Paper Appendix


Source: FDA

Thanks to W. Conn for the hat tip.