Sentrian, the maker of a remote patient intelligence (RPI) solution designed to avoid preventable hospitalization, has received confirmation from the US Food and Drug Administration (FDA) that its platform meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.” That designation means the RPI solution is “not subject to further FDA regulatory requirements at this time,” and enables the company to immediately begin marketing its RPI solution in the US.
The decision comes following a February 9, 2015 Mobile Medical Applications report, in which the FDA stated its intention to take a tailored, risk-based approach to regulating medical devices and focus only on those technologies that meet the regulatory definition of “device.” The agency said that for mobile and cloud-based applications that are technically “devices” but which pose minimal risk to patients, it would use enforcement discretion and would not expect manufacturers to submit premarket review applications or register their products.
“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, cofounder 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 chronic obstructive pulmonary disease by increasing our product development speed and agility.”
According to the company, Sentrian’s cloud-based technology and analytics platform combines biometric devices and machine learning to detect actionable health deterioration early and with higher accuracy, helping to reduce preventable hospitalization in patients with complex chronic disease. The platform is designed to integrate with existing healthcare information systems and clinical workflows in order to facilitate adoption.
For more information, visit the Sentrian website.
This article may serve to add new confusion to “clears”. Some people are careful to use cleared to mean an FDA action with respect to a Class II device for which a 510(k) was submitted. Approved means a positive FDA action with respect to a Class III device for which a PMA was submitted. Now comes the “regulatory discretion” domain for which the FDA has said yes you are a medical device but we aren’t going to apply the regulatory processes to you anyway. Is this “cleared” or do we need a new term? “Passed over” perhaps. Allowed? Disinterested?