It wasn't long ago that we encouraged readers to keep track of FDA's new innovation pathway. We hold to that. But since FDA has been busy creating other paths to market—namely the new Class I Medical Device Data Systems category—it makes sense for folks to keep a close eye on that as well. From FDA's news release:
Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.
Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.
Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device.
Down-classifying these products from Class III to Class I is a big deal for manufacturers, primarily because it means a lot less work to earn clearance or approval for products that don't require the same levels of rigor in testing and safety. What will be interesting is how FDA works out any potential kinks in the approval pathway. But as we pointed out with the innovation pathway, medical devices with embedded electronics are ultimately going to be the products that shape existing and future regulations. —Lawrence Lloyd