By Diana Manos, Healthcare IT News | January 10, 2019

The new Digital Health Innovation Action Plan is part of the agency’s broader effort to improve oversight of technologies.

The Food and Drug Administration (FDA) has released its first ever guidance on how it plans to work toward a more streamlined and timely approval of artificial intelligence and other digital health products.

The Digital Health Innovation Action Plan, released Jan. 7, is part of FDA’s Pre-Cert Pilot Program to review products, including AI, and is another step in a series of steps FDA plans to take to “reimagine” its oversight of digital health tools.

FDA is “aiming to make the agency more efficient, while promoting safety throughout a product’s lifecycle,” said FDA Commissioner Dr. Scott Gottlieb, said in a statement.

Gottlieb added that FDA’s goal in piloting the Pre-Cert program has been to support new tech, as well as learn from new developers about their products. The new strategy released Jan. 7 will help FDA appraise new products before they are submitted, by grading the developer’s “culture of quality and organizational excellence,” to be known as an “Excellence Appraisal.” This appraisal will help streamline the premarket submission process for specific types of digital devices, according to FDA.

FDA is seeking public comment on this new guidance.


After speaking with stakeholders, FDA officials believe the most efficient way the agency can test the Pre-Cert program is within the FDA’s current regulatory authorities. And so, on Jan. 7, the agency also released regulatory guidance, called “Regulatory Framework for Conducting the Pilot Program within Current Authorities,” to explain how FDA intends to use its De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot.

Original Article