Theis notorious for being slow to implement the type of technology that has revolutionized other industries such as retail, media and manufacturing. And there's one big reason why: Regulation.
But that's changing. Over the past decade, the US Food and Drug Administration has recognized that the systems the agency has in place to apps that help detect skin cancer and smartwatches that can take your blood pressure.)moderate- to high-risk hardware-based medical devices (such as implantable pacemakers and breast implants) aren't appropriate for the low-risk software-based medical technologies flooding the market place today. (These include
Why? Unlike hardware, which manufacturers typically update every few months to years, software-based devices can quickly be tweaked in response to real-world performance and consumer feedback.
If a company making these products had to submit paperwork to the FDA for review -- and then wait for a thumbs up -- every time it wanted to make these changes, it would lead to a backlog. That means innovation would slow and potentially health-boosting technologies would take longer to reach consumers.
In July 2017, the FDA's Center for Devices and Radiological Health (CDRH) released a Digital Health Innovation Action Plan to address this problem. As part of this plan, the agency proposed a new software "precertification" program and invited companies who make software-based health devices to help them test it.
More than 100 companies applied, but only nine were chosen -- including Apple, Fitbit and Samsung. Since then, the FDA has been quietly making progress, despite staffing changes at the highest levels of the organization. Here's what we know about the program so far.
What is the Software Pre-Certification Program?
The FDA currently reviews medical devices -- and modifications to medical devices -- using established premarket pathways, such as premarket clearance (510(k)), De Novo classification, or premarket approval.
The Software Pre-Certification (Pre-Cert) Program that the FDA proposed in 2017 would be a new, voluntary pathway that would streamline the approval process for Software as a Medical Device, or SaMD.
The International Medical Device Regulators Forum defines SaMD as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." The Apple Watch ECG app is a good example.
In theory, the Pre-Cert Program would make it faster and cheaper for companies to bring new software-based medical devices -- or updates to existing devices -- to market. In turn, this is expected to foster innovation and ensure consumers have timely access to the latest health technologies.
How would the Software Pre-Cert Program Work?
The FDA is still trying to figure that out. According to Working Model 1.0, the agency's most recent draft, any company -- big or small -- that makes software-based health products could apply for precertification.
The CDRH (or an FDA-accredited third party) would then evaluate whether that company meets the following five standards:
- Product Quality: Demonstration of excellence in the development, testing, and maintenance necessary to deliver SaMD products at the highest level of quality.
- Patient Safety: Demonstration of excellence in providing a safe patient experience and emphasizing patient safety as a critical factor in all decision-making processes.
- Clinical Responsibility: Demonstration of excellence in responsibly conducting clinical evaluation and ensuring that patient-centric issues, including labeling and human factors, are appropriately addressed.
- Cybersecurity Responsibility: Demonstration of excellence in protecting cybersecurity and proactively addressing cybersecurity issues through active engagement with stakeholders and peers.
- Proactive Culture: Demonstration of excellence in a proactive approach to surveillance, assessment of user needs, and continuous learning.
Companies that meet these principles would qualify for one of two levels of precertification. These precertified companies could then start selling or updating their products without waiting for FDA clearance, or after going through a more streamlined, expedited review process than what's required today.
Once that product is on the market, precertified companies would also be obligated to share post-market data -- such as performance reports or the results of clinical studies -- with the FDA for ongoing monitoring.
What challenges does the Pre-Cert Program face?
The biggest challenge will be fleshing out all of the details missing from version 1.0, which the FDA released in January. "I actually think 1.0 is a bit of a misnomer," regulatory lawyer Bradley Merrill Thompson wrote in MobiHealthNews. "It ought to be labeled something like version 0.7, because it's really about 70% of a complete proposal. It lacks many of the details necessary to give an understanding of how it will work."
Politicians have expressed similar concerns. On Oct. 10, 2018, Senators Elizabeth Warren, Tina Smith and Patty Murray sent a 12-page letter to the FDA outlining theirs.
"We support FDA's efforts to update the medical device review regime to better accommodate digital health devices and believe that it is an important step in ensuring that America remains an innovative, cutting-edge producer of medical devices," the senators wrote. "However, it is essential that changes to FDA's regulatory framework are done in compliance with the current statutory framework and do not compromise public safety."
The FDA, to its credit, has said it's committed to collaboratively and transparently working through any issues. The agency continues to ask for, review, implement and share public input on the program.
What is the Digital Health Software Pre-Certification Pilot Program?
The Pre-Cert Pilot Program is designed to evaluate the current working model of the Pre-Cert Program and inform how the FDA ultimately establishes the program (read the full test plan).
Working with the nine companies selected in 2017, the FDA will parallel path product approvals during this testing period, evaluating them the current traditional way and the proposed Pre-Cert way.
At this time, the Pre-Cert Pilot Program will focus on free-standing health software that's intended to diagnose or treat disease. In the future, the program could be expanded to include software in medical devices, such as what's used in a pacemaker.
What companies are taking part in the Pre-Cert Pilot Program?
The nine companies the FDA selected to take part in the Pilot Program are:
- Johnson & Johnson
- Pear Therapeutics
- Verily (Alphabet Inc.'s research arm)
The FDA has also invited other companies that are planning to submit a premarket application in 2019 to volunteer to be a test plan participant.
What's the current status of all these efforts?
The FDA began testing the Pre-Cert Program with the nine companies listed above at the beginning of the year. The information collected from these tests will be used to determine whether the results of the Pre-Cert pathway align with the results of the traditional pathway and satisfy the FDA's regulatory requirements for safety and effectiveness, according to the agency's mid-year update.
Because changes at big government agencies such as the FDA can take time, it might be a while before we see the full effects of this program. But assuming everything goes well, and these new approval processes for software-based medical devices meet the FDA's requirements, we might start to see way more smart health products integrated into our everyday lives.