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The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital health premarket review timelines. Digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.

The creation of this unit is part of the Medical Device User Fee Act (MDUFA). MDUFA is the program that authorizes FDA to collect user fees from medical device manufacturers in support of streamlining the regulatory approval process. Negotiations between FDA and the medical device industry regarding the fourth version of MDUFA are currently underway. As part of the negotiation process, FDA proposed to hire technical experts to staff the new digital health unit.

In addition to MDUFA, the 21st Century Cures Act requires FDA to develop a framework for evaluating real world evidence. FDA envisions that the digital health unit will monitor and implement the use of real world evidence to support the regulatory approval process. FDA issued a draft guidance in July 2016, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, that identifies how real world data will be evaluated to determine if it is sufficiently relevant and reliable enough to be used.

While the FDA sees the digital health unit as a means of streamlining the regulatory approval process, it also recognizes it will require coordination with industry and other government agencies because digital health touches on a variety of complex areas requiring their own unique knowledge base and expertise, such as artificial intelligence, data privacy and cybersecurity, telemedicine, and the cloud.

As medical device manufacturers, we can hope that the digital health unit will enable our software-based products to achieve FDA clearance with greater efficiency. However, just because the unit has been created, FDA will still need to recruit a team of experts who understand both the software and regulatory worlds, and this will take time.

If your device incorporates software, or if you are not sure if your software is a medical device, our consultants can help. Be sure to ask us about IEC 62304 and Software Development Life Cycle requirements.

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