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

Managed Healthcare Executive February 15, 2023
MHE Staff

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...

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