FDA Relaxes Regulation For Medical Data Storage Devices
After determining that medical device data systems (MDDS) and certain mobile medical technologies posed little patient risk, the FDA released final guidance that seeks to lessen regulatory burden for qualifying devices and encourage the development of digital health technology.
“The FDA guidance distinguishes between functionality and platform in determining whether a mobile app qualifies as a medical device,” said a report by Emergo Group.
Devices and apps are only subject to regulatory oversight if they perform medical device functions and have the potential to interfere directly with clinical treatment. For instance, devices that control insulin pumps, mobile devices attached to electrocardiograph electrodes, and electronic stethoscopes will still be subject to FDA oversight.
Devices that store, track, transmit, receive, or display data without controlling the function of an attached medical device will be exempt, according to the FDA in their MDDS guidance. The FDA also updated their guidance for mobile apps to match its newest clarified approach to digital medical devices.
Examples of MDDS include glucose meters, blood pressure cuffs, and weight scales designed for home use and equipped with technology that tracks and stores information. Also, databases for patient health reference, clinical calculators, and systems that allow patients to document the symptoms of their illnesses will not be subject to FDA approval.
For these types of devices, the new guidance stipulates that “the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, post market reporting, and quality system regulation for manufacturers.”
The FDA made the decision to relax its grip on digital health after determining which kinds of devices posed the greatest health risks if they were to malfunction. Data tracking and storage devices, they decided, posed little to no danger to the patient.
“We continue to clarify which medical devices are of such low risk that we will no longer focus our regulatory oversight on them or we will regulate them under a lower risk classification, narrowly tailoring our approach to the level of risk which patients or consumers are exposed,” CDRH's Bakul Patel and Jeffrey Shuren blogged.
Without the FDA staring over their shoulders, device developers and manufacturers will have greater freedom, and a report from Forbes suggested that “the guidance has given investors and entrepreneurs the greenlight to pour billions of dollars into digital health.”
According to the FDA blog, this was the intention. “We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data,” the authors said.
For more details on which devices are and are not subject to oversight, both guidances include lists of qualifying devices in their respective appendices.