FDA upgrades approach to certifying new AI products

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.

The FDA’s De Novo pathway is well-suited to meet the goals of the Pre-Cert program, says Gottlieb. It’s a pathway for low- to moderate-risk devices to obtain marketing authorization. The FDA’s Excellence Appraisal could streamline a De Novo submission, he says.

FDA will be testing this out this year, to see how well this new method of appraisal and approval works compared to the traditional method.


Last year, Gottlieb said FDA expects to see an increase in the number of AI-based submissions, particularly medical imaging devices. In addition, he said that FDA expects that AI tools can become even more predictive as additional real-world data is fed into these algorithms. It appears FDA is delivering on its promise to move these products to market sooner.


“Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health,” Gottlieb said. “Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.”

Diana Manos is a Washington, D.C.-area freelance writer specializing in healthcare, wellness and technology. 

Twitter: @Diana_Manos
Email the writer: [email protected] 

Healthcare IT News is a HIMSS Media publication. 

Source: Read Full Article