For Digital Therapeutics, Many Issues. But FDA Process Is Not One of Them.


Digital therapeutics are regulated like devices by the FDA. Andy Molnar, the CEO of the industry’s trade organization, the Digital Therapeutics Alliance, says the FDA clearance and authorization process for digital therapeutics “works.”

Second of two parts

Compared with medications and medical devices, digital therapeutics are newcomers to the sometimes complex and often arcane ways of the FDA approval process. Rather than cooking up a new process from scratch for digital therapeutics, the federal government’s regulatory agency has decided to review and approve digital therapeutics in the same way it reviews and approves medical devices.

And, for now, that suits the digital therapeutics industry just fine

“With FDA, we do say, OK, at least this works,” says Andy Molnar, CEO of the Digital Therapeutics Alliance, the six-year-old trade association for the budding digital therapeutics industry. In contrast, Molnar notes, Centers for Medicare and Medicaid Services (CMS) and, more specifically, the Medicare program, have no process that the digital therapeutic companies can use to gain Medicare reimbursement. The association is lobbying to Congress to pass legislation that would open up Medicare reimbursement for prescription digital therapeutics.

Molnar and Sara Elalamy, the group’s director of U.S. government affairs, were recently interviewedby Managed Healthcare Executive®.

Related: Digital Therapeutics Alliance Has Doubled in Size

Technically, the FDA does not “approve” medical devices and digital therapeutics, Molnar and Elalamy noted. Approval is reserved for drugs. The agency “clears” or “authorizes” devices and digital therapeutics. “When I saw ‘approval,’ everybody corrects me,” Elalamy says.

Sara Elalamy

Sara Elalamy

For FDA clearance and authorization purposes, devices and digital therapeutics arere grouped into class one, two or three. Class one devices are those that pose little if any risk of causing harm, such as tongue depressors and toothbrushes. Class two devices, which the FDA deems as posing an intermediate or medium risk of resulting harm, include CT scanners and infusion pumps. Molnar says the FDA views almost all digital therapeutics as class two devices. Class three devices are seen as posing the greatest potential risk and include implantable devices such as pacemakers.

“I’ve heard of a few companies that are going for class three (approval), but I have not heard that have gotten through the process yet,” says Molnar. Those digital therapeutics likely work in some way with devices that are implanted.

Like devices, digital therapeutics may also be evaluated in the “510(K)” process, which means that the maker shows that the digital therapeutic is “substantially equivalent” to one that already has received an FDA OK.

Molnar says digital therapeutics must indicate on their FDA application whether the product is prescription or not. “You can’t be silent on it. You have to say during the application whether or not its prescription or nonprescription.”But he says that the FDA says most of the class two digital therapeutic products should be prescription.

The prescription versus nonprescription distinction may become especially important when it comes to Medicare coverage because the legislation that the Digital Therapeutics Alliance is currently lobbying for would limit coverage to prescription digital therapeutics, Molnar and Elalamy explain.

Supporting evidence from a clinical trial has been an important criterion for products that the alliance views as digital therapeutics in contrast to the thousands of health and wellness apps.

But Molnar there is a growing demand for the digital therapeutics to have real-world evidence behind them.

“We do love to see publications about how it functions in the real world. And it is not just coming from us as a trade organization. It’s coming from provider, payers, professional associations that really want to make sure that when you take these (digital therapeutics) out of controlled trial that they still function in the way you say they will.”

“It is incredibly important,” Molnar continues, “particularly when engagement is one of the most important drivers for an effective outcome when it comes to digital health.”

Although putting digital therapeutics into the existing the pathways for FDA clearance and authorization of device has worked out for the digital therapeutics industry, Molnar says both the FDA and the industry are grappling with issues that are still taking shaping.

“I think AI (artificial intelligence) is probably one of important things. How do you treat AI?” Molnar says.

Many other unanswered questions are looming, in Molnar’s telling. The initial OK for a digital therapeutic might be the easiest part, conceptually, he says.

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