1. Class I General Controls
2. Class II General and Special Controls
3. Class III General Controls and Premarket Approval
The FDA approved Intuitive Surgical's da Vinci surgical system not as a robotic system... because at that time they didn't have any such classification. Instead it fell under the rules and definitions of a tele-manipulated medical device.
In the FDA workshop on Medical Care Robots, held in Washington, DC, February 19, the FDA was attempting to update their definitions for present and emerging medical and personal care robotics.
There were 60+ participants. Military and VA, hospital administrators, medical device manufacturers, lawyers, engineers, standards experts, surgeons, professors, FDA staff. Very sharp crowd carefully parsing proposed definitions from the ISO (International Organization for Standards) with the wisdom of their particular experience. There was resistance to the definitions that were proposed and to the implied compliance once those definitions were finalized as if there was money on the table.
One politically savvy scientist said that his father taught him that when attending a meeting such as this one, that all the information wasn't presented, factual, nor even known, and that any consensus involved money. There is money involved in the approval process. If the product is a Class III, involving premarket approval, much cost in time and money are likely for trials and discussions leading to approval. Thus the somewhat contentious interplay between the attendees to insure that the products they represent will be categorized in the least costly approval grouping. Suggestions ranged from special hygiene and safety requirements all the way to the addition of a "black box" which accumulates all the data streams of a medical robot so that the data is available to be reviewed for educational, accident investigation and other statistical purposes.
I attended because I am interested in emerging robotic products and applications in health care. It's a big industry and a big user of new technologies, many of which are emerging with breakthrough inventions almost every day.
A comparison to new imaging, medical and robotic technologies available to a surgeon would be the technological advances in boating and airplane piloting. First there was radar and paper charts. Then there was GPS, electronic charts and navigational systems. Then radar data was overlaid on top of the digital charts and tags were given to planes and ships to identify them. With the radar points, the chart points, ship/plane identity tags and some clever software, ships and airplane pilots are now able to visualize the direction, speed and size of ships/planes in their sphere. With adaptive auto-pilots working in concert with all this and additional wind/speed/currents data, the ship/plane can steer it's course adjusting for wind and sea variants and the pilot can visually oversee the progress. Add 3-D vision and one can easily see the level of capability - and complexity - available to pilots, ship's captains, and surgeons as these systems augment their skill and judgement.
The FDA's role in all this is to provide regulation of those devices that affect humans. Various classifications were suggested by the participants. I've presented one set of classifications from the folks at Intuitive Surgical (click here to see the whole PDF file):
- Surgical assist devices (scope positioners)
- Surgeon augmentation devices (enhance skills, eg: da Vinci and guided catheter systems)
- Caregiving augmentation devices (remote presence, physical therapy, play therapy)
- Hospital augmentation devices (pill dispensers and transport systems)
- Patient augmentation devices (bionics and exoskeletons)
- Decision support devices (remote presence, medical diagnosis)
- Autonomous action medical devices (smart artificial pancreas)
- Autonomous care-giving devices (robotic wheel chairs, feeding and bed turning)
The whole discussion of robotic classifications suggests the quickly changing movement in the industry and has me rethinking the categories that I currently use for The Robot Report's directories. Perhaps additional segmentation of Service Robotics beyond the two present categories...? And a new grouping for embedded systems? Comments? Suggestions?