The Food and Drug Administration is a frustrating but inevitable bottleneck for companies developing health tech, but that might be about to change. Apple, Fitbit, Samsung and six other major tech companies have just been admitted onto a pilot program that will let them fast-track future health products.
The FDA has a lengthy approval process, which can hold companies back when developing more serious medical tech. This new pilot scheme would instead let them eschew normal regulatory cycles and be granted approval more quickly. As a result, it should encourage health tech names to be more ambitious in developing more medical-grade technology for devices, whether it's the Apple Watch or Fitbit's gamut of trackers.
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For example, the Fitbit Ionic is equipped with relative SpO2 sensors for detecting sleep apnea, but Fitbit cannot roll this out until the accuracy is validated. Rather than going its own way, it can now take the FDA path and potentially get its sleep apnea detection validated and rolled out to devices much faster. Similarly Apple is currently working with Stanford clinicians to research how the Apple Watch could detect abnormal heart rhythms, something that would most likely require FDA approval if it were to diagnose.
Also among the names is Verily Life Sciences, the health unit of Alphabet, which also works with glucose tracker maker Dexcom. You might recall that Verily was the one working on glucose-tracking contact lenses.
Participating companies will have to provide FDA with access to their testing measurements, information about quality management and real-world data they have collected. If approved, the companies could be granted a pre-certification and won't have to face such rigorous approval.
"We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices," said FDA Commissioner Scott Gottlieb on the new pilot scheme.
Fitbit CEO James Park also said in a statmeent: "As Fitbit takes a more integrated role in personal healthcare, we are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly."