Lessons from FDA Multiple Function Device Guidance
Attorneys Gregory Levine and Abram Barth (Ropes & Gray) say that an FDA 4/27 draft guidance “provides insight into how FDA conceives of its authority to regulate multiple function devices consistent with the 21st Century Cures Act.” They say the document may be useful not only for manufacturers of products that contain software functions that meet the definition of a device, but also multiple function devices where the other function involves hardware, not software. In particular, the attorneys write, the draft guidance emphasizes the need to think carefully about product design and architecture early in product development.
Where possible, they say, designing device architecture with clear lines of demarcation between the device and other functions of the product can be valuable. And where the device and other functions are necessarily interdependent, risk mitigation assessment and documentation becomes paramount.