FDA Executives Outline Smart Regulation Approach in Two New Draft Guidance Documents on Digital Health

Last month, the FDA released two draft guidance documents on internet-based medical devices. Last week, two FDA executives outlined the agency’s regulatory intentions and specific details regarding medical devices. VCBeat has compiled the information as follows:

Patient Engagement! Quantified Self! Life Logging! These terms describe exciting new technologies centered on patients and healthier living. Countless systems can record, share, and help individuals understand their personal health data, accessible with just a tap of the fingertip, significantly promoting healthy lifestyles. The ultimate goal of these products is to improve our quality of life.

From wearable sensors to simple tracking applications, an increasing number of consumers are opting for technological devices to monitor their health and help motivate them to engage in health-promoting activities. Key features include step counting, calorie calculation, heart rate monitoring, and sleep quality assessment, all designed to help individuals establish a healthy lifestyle.

The FDA is continuously adjusting its regulatory model, seeking to promote reforms in this field to advance public health and meet the needs of patients and consumers.

In early February, the FDA finalized its guidance on Medical Device Data Systems (MDDS) and last month released two draft guidances concerning internet-connected medical devices, employing a risk classification approach similar to that used for medical device accessories.
The guidance for the FDA Safety and Innovation Act Health IT Report (FDASIA Health IT Report) will be released in April.

Through these actions, the FDA will clarify which medical devices are considered low-risk and thus no longer subject to FDA oversight, or reclassify them into a lower risk category, carefully adjusting regulatory frameworks to avoid unnecessary risks to patients or consumers.

The intent of the Medical Device Data Systems (MDDS) guidance is not to mandate that medical device data systems, which receive, store, transmit, and display data from medical devices, comply with FDA regulations. Rather, the policy aims to foster the momentum for the development of this emerging technology. The FDA has also updated its guidance on Mobile Medical Applications (MMAs) to align with the MDDS guidance. Bakul Patel, Deputy Director for Digital Health at the FDA’s Center for Devices and Radiological Health, stated, “They will discuss MDDS in detail in an upcoming webinar.”

Bakul Patel

For example, the FDA will regulate applications that perform medical device functions, namely mobile medical apps.

Applications that analyze patient data from connected devices, or applications used for patient monitoring;

An application connected to a device, designed to control its operation, functionality, or energy;

An Application That Transforms a Mobile Platform into a Regulated Medical Device.

For applications that do not have medical functions, the FDA will adopt a "hands-off" policy, such as:

Applications that help healthcare institutions automate simple tasks;

Applications that interact with healthcare institutions through Electronic Health Record (EHR) systems;

Self-management applications that do not provide specific treatment advice;

Last month, the FDA also recommended deregulating products intended solely for general health. These products are designed to maintain or encourage general health or promote healthy lifestyles that reduce the risk of certain diseases. We hope this policy will foster the development of such low-risk products.

Finally, the FDA has established a separate regulatory framework for parent devices and issued a draft guidance on regulating medical device accessories. Some accessories may pose lower risks compared to their parent devices and thus may be classified into lower risk categories. For example, a Class III medical device that poses low risk may be reclassified as Class I or Class II through regulatory measures.

Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, stated, “Through this smart regulatory approach, we can better foster innovation while protecting patients.”

Jeffrey Shuren

Click here to download the two guidelinesHere。

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