FDA clearance — it’s not easy to get, but when you manage to get it, it’s a major accomplishment and a critical component in modern healthcare tech marketing.
Sentrian, a Remote Patient Intelligence company, says it has received confirmation from the Food & Drug Administration that its Remote Patient Intelligence solution reportedly meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.”
The designation identifies medical devices that “are not subject to further FDA regulatory requirements at this time” and clears the way for Sentrian to immediately begin marketing its RPI solution broadly in the U.S.
As mHealthWatch has reported throughout the year, last February the FDA released a Mobile Medical Applications report announcing it would take a tailored, risk-based approach to regulating medical devices, with a focus on the small subset of technologies that meet the regulatory definition of “device.”
For the many mobile and cloud-based applications that the FDA deems a “device” but which pose minimal risk to patients and consumers, the agency will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or register their products.
With that in mind, the FDA is giving a green light to Sentrian.
“We are encouraged by the FDA’s well-balanced approach to nurturing innovation in mHealth while ensuring patient safety in their assessment process,” said Dean Sawyer, Co-Founder and CEO of Sentrian. “The FDA’s decision enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, complex diabetes, and COPD by increasing our product development speed and agility. It also affirms Sentrian’s mission to improve the quality of life for the patients we serve.”