EMERGO SUMMARY OF KEY POINTS:

• The US FDA is planning a new, more systemic program to address whether and how mobile medical apps and digital health products should be regulated.
• The pilot program may include third-party certification pathways for lower-risk digital products as well as post-market real-world data collection to expedite FDA registrations.
• The program is expected to launch in the fall of 2017.

The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies.

FDA Commissioner Scott Gottlieb recently wrote that besides implementing digital health provisions of the 21^st Century Cures Act, the agency will also pursue a new program that may utilize third-party certifications and post-market oversight, as well as issue further guidance to explain which types of digital products would fall under medical device regulatory requirements and which would not.

Pilot program for third-party certifications

According to Gottlieb, the FDA is currently developing a pilot program to launch later in 2017 that will potentially allow third-party certifications for lower-risk mobile medical technologies to obtain US market authorization without undergoing premarket review. Third-party certification is also being considered for faster premarket reviews of higher-risk digital health products including software as a medical device (SaMD).

Post-market oversight and data collection

Another component of the new FDA program will include post-market data collection on digital medical products via platforms such as the National Evaluation System for health Technology (NEST).

(The US government is currently in the process of launching NEST as a central system to manage various healthcare data sources; the system should become fully operational in 2019.)

Gathering real-world post-market data on digital health products already on the US market will help expedite future FDA registrations of similar products as well as allow easier expansion of indications for use for these technologies, argues Gottlieb.

Moving away from case-by-case determinations

Although US regulators have issued guidance and held public workshops addressing how and whether to regulate digital health products as medical devices, the new FDA pilot program Gottlieb describes suggests that the agency will adopt a more systematic and (hopefully) predictable regulatory approach for mobile medical apps and related products; determinations on whether such products qualify as regulated medical devices are currently often made on a case-by-case basis, making it challenging for app developers and manufacturers to predict what if any FDA compliance efforts will be necessary to enter the US market.

Emergo will further analyze the new FDA pilot program for digital health products once the regulator provides more details on the project.

Related US regulatory resources from Emergo:

• US FDA medical device regulatory strategy support
• Regulatory consulting for mobile medical and telehealth products
• Whitepaper: FDA 510(k) clearance for mobile medical apps