The global market for mobile medical apps designed for healthcare professionals is expected to reach $14 billion by 2020 according to Global Industry Analysts. Consumer demand and shifts toward value-based care and mobile health have helped fuel wider adoption of health apps, remote monitoring, and Software as a Medical Device (SaMD).

FDA takes a "hands off" approach toward lower-risk digital health technology (a fitness tracker or an educational resource, for example). However, it has faced challenges in how to best regulate what it considers SaMD.  

As a step toward an efficient process for SaMD regulation that ensures patient safety without hampering innovation, FDA recently launched its Software Precertification (PreCert) Pilot Program.

The program's goals are threefold: to streamline pre- and postmarket obligations for software regulated as a medical device; to ensure quality products throughout their lifecycles; and to adapt to the needs of developers. The pilot program is part of FDA's Digital Health Innovation Plan, which focuses on fostering digital health innovation while continuing to protect and promote public health.

"Our goal is to create a program that is aligned with how products are being developed and how quickly they come to market, as well as one that's aligned internationally with other regulators," said FDA associate director for digital health Bakul Patel. "This is about creating a new paradigm."

Medtech and FDA, Working Together

FDA will select only nine companies, from small startups to large companies, and both traditional and nontraditional medical device manufacturers. FDA and pilot participants will work together closely to develop the program.

"This is an experiential pilot," said Zach Rothstein, associate vice president, technology and regulatory affairs for Advanced Medical Technology Association (AdvaMed). "They're taking concepts talked about in theory and figuring out how to apply them in the real world."

FDA will meet with pilot participants to learn about their respective companies and specific use cases. Ongoing discussion will help FDA determine steps for getting products to market, data collection, and other processes through the product lifecycle.

The pilot program will also involve public input. "Once we understand what the components of the paradigm will look like, we will have a larger discussion with the public in early 2018," said Patel.

Because the PreCert Pilot Program is such a work in progress, FDA has no firm timeline for the pilot program's duration. The nine companies selected for the pilot will have a rare opportunity to shape what will be a new initiative for FDA.

AdvaMed; which, along with the Medical Imaging & Technology Alliance (MITA), worked with FDA on developing the concepts of what a pre-cert program would look like, said its member companies support the program and are excited to possibly participate and work hand-in-hand with a governmental agency.

"The immediate results of participating in the pilot is building trust and good will with FDA at this stage," said Rothstein. "The participating companies will also learn a lot. It's like having FDA as a member of their team."

Kalle Soderholm, chairman of Health Invest, a Finland-based healthcare firm that developed My+Care(TM), an end-to-end, cloud-based elder care system, views the PreCert Pilot Program as a positive forward move. "The intent to leverage stakeholders across the healthcare environment will create a well-balanced program with more practical and comprehensive outcomes," he said. "FDA has taken a good first step toward the creation of a long-term, standardized digital health regulatory pathway."

It will take time and legislative and regulatory changes to get a permanent pre-certification program in place. In theory, however, the program lessens the regulatory burden for SaMD companies while adhering to the overall goal of patient safety.

"I think companies will get a better experience if they're part of the pre-cert program," said Patel. "We expect pre-market review to be more streamlined as we move forward. We also expect more transparency and clarity in terms of what people need to do as they engage in their regulatory systems."

Patel said pre-certified companies developing low-risk products may not need to file a 510(k). "Being pre-certified, low-risk products could potentially go straight to market if we have a full understanding of the type of company that's making that product," he said.

"We would welcome the opportunity to enter into a permanent pre-certification process within a Software as a Medical Device (SaMD) program," said Soderholm. "Such a program provides the opportunity to give feedback through our system, whether to regulatory bodies, end users, or clinicians. Anything to support transparency, clinical outcomes, and usability is exciting to us."

When in Doubt, Apply

Patel said FDA plans to start the pilot program in early September, even if it hasn't selected all nine participants. He encourages companies to apply up to and even after September 1. For one, FDA may still have openings. Second, it gives FDA important feedback.

"It tells me people are willing to help us, and we may take that help at any point during the pilot program, even if we're beyond the nine participants," Patel said. "We want to consider everybody's perspective in this phase because it's important for us to get it right."

Heather R. Johnson is a freelance writer based in Oakland, California. 

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