If Apple wants to add new medical device-like health monitoring features to its Apple Watch, will the company need to go to the Food and Drug Administration (FDA) for review?

The question gained momentum recently with rumors that Apple is trying to develop a device which would let patients check blood sugar by touching their skin rather than using a painful pin prick, according to news reports.

The speculation builds, too, as this week the FDA announced Apple was one of nine companies the agency has approved for a new pilot “Precert” program, known as Digital Health Software Precertification. Under this pilot program, the agency would review the software developer or digital health technology developer on certain criteria, rather than focusing solely on the product. While some details still need to be worked out on the FDA initiative, it is designed to be a time saver.

Law professors familiar with FDA regulations note that if Apple wants to move ahead with medical device-type functions for Apple Watch, the company will likely need to go to the FDA for review.

“If Apple designs and intends for the Watch to perform medical device functions, it would by definition fall under the FDA's jurisdiction,” Nathan Cortez, a law professor at Southern Methodist University, told Legaltech News.

Nicolas Terry, a professor at Indiana University School of Law, said such a device “would likely fall squarely within [the] definition of medical device—both hardware and software aspects.”

And Erika Lietzan, a professor at the University of Missouri School of Law, also agreed, telling Legaltech News, “Absolutely, these could be medical devices.”

“The statutory definition is pretty broad—pretty much anything that is intended for use in diagnosis or treatment of disease, so long as it isn't metabolized or working chemically in the body,” she said. “[The] FDA has the authority to regulate software and apps for smartphones and similar devices as a result of this broad definition.”

As a result, Apple—or any other similar technology company including medical information into its devices—should be aware of FDA rules and regulations throughout the development process. Lietzan noted that the FDA is taking a risk-based approach to these devices and will exercise enforcement discretion for apps that pose minimal risk to consumers and patients.

“To give an example, it doesn't regulate smartphone apps that help users track their conditions,” she added. “My instinct is that it would regulate a blood glucose monitor, even if that device was non-invasive. They regulate non-invasive blood pressure wrist monitors, for instance.… And they have said, expressly, that they would regulate 'mobile apps that use an attachment to the mobile platform to measure blood glucose levels.'”

Lietzan identified another twist. “The FDA has been very solicitous of Apple's feedback—and vice versa. The company has met with the FDA a few times to get the agency's feedback on whether it would regulate Apple's products,” Cortez explained earlier this week. Looking back, “the FDA has largely carved out the Apple Watch, iPhones, etc., from FDA oversight.”

Also, Terry explains that the “limited health and fitness aspects” of the watch were allowed by the FDA under a published regulatory guidance “under which [the] FDA exercised regulatory discretion for classes of mobile medical apps and devices.” That guidance “was firmed up by the bipartisan 21st Century Cures Act passed late last year,” he said.

Overall, however, new technology that is considered a regulated device and would fall under FDA oversight—whether from Apple or another company—would have to abide by such regulations as good manufacturing practices, registering the company as a device maker, listing all FDA-regulated devices the company manufactures, and adverse event reporting, Cortez explained. “Also, the company would need FDA approval or clearance for new products and product functions.”

And what do traditional medical device manufacturers think about Apple and the FDA? Terry said that companies like Apple, Samsung and Fitbit are “not really disrupting [the] traditional medical device market,” but that device manufacturers are “more likely keeping a watchful eye on Google Deep Mind or Verily.”

Cortez added that the conventional wisdom is that “companies want their competitors to operate on an even playing field, which in this case means not skirting and designing around FDA regulations.”

On the other hand, companies like Apple may even find some benefit if regulated by the FDA. “Given the sheer number of new products in the digital health market, and the challenge this volume poses to patients, physicians, and other consumers who have to choose among dozens, if not hundreds of competing products, many companies are looking for the FDA's stamp of approval to stand out in a crowded market,” Cortez said. “Being FDA cleared or approved also means you can make certain claims about your product that you otherwise couldn't make.”

Other companies approved for the FDA precert pilot include Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

If Apple wants to add new medical device-like health monitoring features to its Apple Watch, will the company need to go to the Food and Drug Administration (FDA) for review?

The question gained momentum recently with rumors that Apple is trying to develop a device which would let patients check blood sugar by touching their skin rather than using a painful pin prick, according to news reports.

The speculation builds, too, as this week the FDA announced Apple was one of nine companies the agency has approved for a new pilot “Precert” program, known as Digital Health Software Precertification. Under this pilot program, the agency would review the software developer or digital health technology developer on certain criteria, rather than focusing solely on the product. While some details still need to be worked out on the FDA initiative, it is designed to be a time saver.

Law professors familiar with FDA regulations note that if Apple wants to move ahead with medical device-type functions for Apple Watch, the company will likely need to go to the FDA for review.

“If Apple designs and intends for the Watch to perform medical device functions, it would by definition fall under the FDA's jurisdiction,” Nathan Cortez, a law professor at Southern Methodist University, told Legaltech News.

Nicolas Terry, a professor at Indiana University School of Law, said such a device “would likely fall squarely within [the] definition of medical device—both hardware and software aspects.”

And Erika Lietzan, a professor at the University of Missouri School of Law, also agreed, telling Legaltech News, “Absolutely, these could be medical devices.”

“The statutory definition is pretty broad—pretty much anything that is intended for use in diagnosis or treatment of disease, so long as it isn't metabolized or working chemically in the body,” she said. “[The] FDA has the authority to regulate software and apps for smartphones and similar devices as a result of this broad definition.”

As a result, Apple—or any other similar technology company including medical information into its devices—should be aware of FDA rules and regulations throughout the development process. Lietzan noted that the FDA is taking a risk-based approach to these devices and will exercise enforcement discretion for apps that pose minimal risk to consumers and patients.

“To give an example, it doesn't regulate smartphone apps that help users track their conditions,” she added. “My instinct is that it would regulate a blood glucose monitor, even if that device was non-invasive. They regulate non-invasive blood pressure wrist monitors, for instance.… And they have said, expressly, that they would regulate 'mobile apps that use an attachment to the mobile platform to measure blood glucose levels.'”

Lietzan identified another twist. “The FDA has been very solicitous of Apple's feedback—and vice versa. The company has met with the FDA a few times to get the agency's feedback on whether it would regulate Apple's products,” Cortez explained earlier this week. Looking back, “the FDA has largely carved out the Apple Watch, iPhones, etc., from FDA oversight.”

Also, Terry explains that the “limited health and fitness aspects” of the watch were allowed by the FDA under a published regulatory guidance “under which [the] FDA exercised regulatory discretion for classes of mobile medical apps and devices.” That guidance “was firmed up by the bipartisan 21st Century Cures Act passed late last year,” he said.

Overall, however, new technology that is considered a regulated device and would fall under FDA oversight—whether from Apple or another company—would have to abide by such regulations as good manufacturing practices, registering the company as a device maker, listing all FDA-regulated devices the company manufactures, and adverse event reporting, Cortez explained. “Also, the company would need FDA approval or clearance for new products and product functions.”

And what do traditional medical device manufacturers think about Apple and the FDA? Terry said that companies like Apple, Samsung and Fitbit are “not really disrupting [the] traditional medical device market,” but that device manufacturers are “more likely keeping a watchful eye on Google Deep Mind or Verily.”

Cortez added that the conventional wisdom is that “companies want their competitors to operate on an even playing field, which in this case means not skirting and designing around FDA regulations.”

On the other hand, companies like Apple may even find some benefit if regulated by the FDA. “Given the sheer number of new products in the digital health market, and the challenge this volume poses to patients, physicians, and other consumers who have to choose among dozens, if not hundreds of competing products, many companies are looking for the FDA's stamp of approval to stand out in a crowded market,” Cortez said. “Being FDA cleared or approved also means you can make certain claims about your product that you otherwise couldn't make.”

Other companies approved for the FDA precert pilot include Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.