Seminal documents on regulation of digital health software in the US.

The FDA has some seminal documents on regulation in digital health software:

• Definition of software As a Medical Device (SAMD)

• Definition of software functions that are a "device" but are regulated via enforcement discretion

• A widget to classify your product as device, not device, or device under enforcement discretion

 

Eversana's overview of 2022

• 2022 summary of FDA developments related to digital health and digital therapeutics, written by Kory Dillman and Marty Culjat at Eversana.

 

Resources for getting oriented in DTx

The Digital Therapeutics Alliance (DTA) has several primers on key topics in DTx:

• Defining DTx and their role in healthcare

• Regulatory pathways around the world

• Crash course in evidence generation fundamentals

 

Exits & Outcomes

• Exits and Outcomes - a subscription newsletter by Brian Dolan that meticulous tracks developments in digital therapeutics. Has several issues per week, plus searchable archives and detailed reports on major players in DTx.

 

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