The Food and Drug Administration's new Medical Device Data Systems (MDDS) rule exempts a small portion of smartphone apps and wireless peripherals from the FDA's pre-review requirements. But that still leaves in limbo a growing majority of apps and remote health devices being developed these days, Brad Thompson, medical device attorney and FDA expert with Epstein Becker Green in New York City, tells FierceMobileHealthcare.
We asked Thompson to break the rule down for us. Here's what we learned:
First, the MDDS rule applies to medical devices or software that only collect, store or transfer patient data. A good example is a smartphone app that collects weight or other vital signs from plug-in peripherals, and forwards that data to physicians.
Previously, the units had been classified as Class III, and had to be approved by the FDA before they could be sold. The new rule categorizes these units as Class I, with no pre-approval requirement, meaning vendors may have an easier (and shorter) path to get products on the market.
But the exemption may be for a shrinking portion of the medical device market, according to Thompson. He sees apps and devices becoming smarter, and offering more functionality, not less. His example: Weight scale apps that trend a patient's weight over time, then use an algorithm to tell the patient how healthy he or she is.
"My sense is that the vast majority of apps are going in the direction of added functionality," Thompson said. "Given the technology that we have, why row a steam ship? Why collect data in an Excel spreadsheet when we can do so much more with that data to make it useful to caregivers?"
Devices like that, that do anything more than store or forward patient data, remain in the Class II and III categories, depending upon their risk levels. And those products can take far longer to bring to market. Thompson points out that the recently launched iPad radiology device from Mobisante took nearly two-and-a-half years to develop, largely because of the FDA approval process.
The good news for other vendors: As part of that process, FDA regulators dug into mobile health hardware and software, and now seem to understand both a good deal more. Thompson's prediction: That even for higher-risk devices and apps, the approval process may soon speed up. - Sara