The U.S. Food and Drug Administration (FDA), which is responsible for drug approvals, medical devices, and the food supply in the U.S., has announced a pilot project aimed at updating the process for approving software-based medical apps and devices. The agency plans to develop a framework that would bypass the traditional process used for drugs and more complex medical equipment.
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The regulator revealed it has chosen nine companies that would participate in the initiative from more than 100 that applied. This includes heavy hitters in health Johnson & Johnson and Roche Holding AG. The list also includes well-known tech titans Apple Inc. (NASDAQ: AAPL), Samsung, and Verily Life Sciences, a division of Google parent Alphabet Inc. (NASDAQ: GOOGL) (NASDAQ: GOOG). Rounding out the top six is fitness-tracking pioneer Fitbit. The remaining three are start-ups Pear Therapeutics, Phosphorus, and Tidepool.
Developing a new approach
As technology has increasingly become a part of consumer health, government regulation has, at times, failed to keep up, leading to uncertainty about what products required government approval. A DNA testing kit released by 23andMe was halted by regulators in 2013, only to be approved recently. Late last year, the FDA determined that devices like standard fitness trackers and other "wearables" wouldn't be subject to regulation.
Apple is involved in a study in collaboration with Stanford Hospital to determine if its Watch can accurately detect an irregular heartbeat. Previous research concluded that the Apple Watch could detect a serious heart problem with 97% accuracy.
For digital health
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Back in July, the FDA announced its Digital Health Innovation Action Plan, whereby it sought to rethink its approach to regulating digital health technology. As part of that plan, the agency announced it would work with companies in private industry to develop the new approach, which it called the Pre-Cert for Software Pilot Program.
FDA commissioner Dr. Scott Gottlieb said the agency wanted to foster technology and ensure consumers had access to safe and effective devices. "Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb in a statement. "We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate."
The "tailored approach" to this technology seeks to approve the developers of digital health technology rather than the traditional approach, which focuses on the products themselves. The program would determine whether companies met certain baseline quality standards for software, and if so, pre-certify them.
Less red tape
By initiating this pilot program, the FDA plans to determine what criteria, such as "key metrics and performance indicators," would allow companies to be pre-certified, and identify ways for them to submit significantly less information than is currently required in order to bring a new digital health tool to market. Depending on the outcome of the program, companies may not be required to submit a product for review at all prior to making it available to the public.
These products could include tools like devices and apps that provide real-time information to consumers regarding certain aspects of their health. The FDA has noted that the healthcare industry has been slow implementing disruptive technology due to the regulatory process for medical devices.
This is an important step in the evolution of government regulation of medical health technology. This collaboration between regulators and industry may help speed up a process that has long been seen as plodding and failing to keep up with recent innovations. The process may also give credibility to digital devices and accelerate the process of getting these to the public more quickly.
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