Health IT

What’s best way of regulating digital health software as medical device? FDA seeks answers with pre-certification program

The FDA is seeking nine companies for a pilot of its pre-certification program accepting applications from companies developing digital health software as a medical device set to kick off September 1.

Pros and cons empty list on blackboard

The U.S. Food and Drug Administration, determined to better its game in keeping up with the Silicon Valley innovation frontier, took the wraps off its pre-certification program for digital health which it’s preparing to pilot.

The FDA set down the criteria that it will use to select nine companies for the trial.

  • It has to be a business developing or planning to develop tools that meet the FDA’s definition of a device — one intended to be used to diagnose, cure, mitigate, treat, or prevent a disease;
  • The company to have an existing track record in developing, testing, and maintaining software products use key performance indicators for quality control;
  • While participating in the pilot, the business must agree to provide access to performance measures;
  • Collect real-world postmarket performance data and provide it to the FDA;
  •  Be available for consultations and site visits from FDA officials; and
  • Provide information about the firm’s quality management system.

As part of the pilot program, the FDA will work with participants to
develop criteria for precertification and the types of information that should be
reviewed during the pre-certification process.

It will start accepting applications for companies interested in pre-certification pilot August 1. The proof of concept program is set to kick off September 1.

Jeff Smith, vice president of public policy for the American Medical Informatics Association, AMIA’s Vice President of Public Policy, said the program has been “eagerly anticipated” by the people who stand at the intersection of technology and medicine.

“We started to hear last year that the FDA was thinking of a regulatory framework that would approximate TSA-precheck…This is a paradigm shift.”

What’s interesting is that the pre-certification program would set up a regulatory framework for software as a medical device whereby companies with established, tried and tested quality assurance protocols would be able to update their products faster. It puts the onus on the company and their quality control measures rather than focusing on each product update they execute. Smith noted that it’s a big departure from the past.

The pilot project will seek to devise the best way of regulating software as a medical device in different use cases for a variety of applications. The move by the FDA reflects both the development of digital health technologies with capabilities never seen before and the need to find a way to regulate that technology that doesn’t needlessly prolong the application and assessment process and deter creativity.

“[FDA digital health director] Bakul Patel is trying to establish what are the guard rails [the FDA] needs to put up,” Smith observed. “I think this is a reflection of applications the FDA is getting right now. They’re trying to recognize there are potential innovations in the market that patients can and should be benefiting from. The FDA is essentially trying to enable a new ecosystem of medical technologies to bloom.”

Photo: marrio31, Getty Images