- FDA is helping advance the development of an artificial pancreas device system (APDS)—an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin
- Forward looking Guidance issued – prior to any approved device – to encourage development
- Recommendations on appropriate endpoints and evidentiary standards for PMA approval; pediatric development encouraged
- Manufacturers need to also focus on Quality System: Software (including sensors) and Hardware. Software problems anticipated. Require design features to prevent malfunctioning of system.
- Cybersecurity concerns need to be addressed.
- Interoperability issues need to be addressed
- Regulatory burden for new technology depends on scope
- Encourage Pre-Submission Meeting to align on required studies and study design to meet Intended Use/Indication for Use. Identify patient population, appropriate software algorithm for dosing for designing trial
- Medtronic has completed pivotal trial with APDS and FDA submission anticipated