The U.S. Food and Drug Administration (FDA) is testing a program that would revolutionize regulation and oversight of certain medical devices. The program is known as Pre-Certification (“Pre-Cert” for short) and could apply to what’s known as “software as a medical device”; that is, software that performs a medical purpose—diagnosis, cure, mitigation, treatment, or prevention of a disease or condition—and that is not part of a hardware device.
FDA regulates more than 190,000 different medical devices like hip implants and MRI machines, the safety and effectiveness of which can be evaluated largely by assessing their design, materials, and performance. Those types of products are modified every few months and, in some cases, years. Software, on the other hand, has more rapid innovation cycles and little can be learned about how safe and effective software is simply by looking at the code. Further, the effect of a hardware device on a patient is generally observable and easy to measure whereas the impact of software on patients may be indirect and therefore difficult to measure.
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FDA says the regulatory model for devices was not designed for software and that a new approach will help encourage innovation while still protecting patients. Pre-Cert relies on a premarket evaluation of the culture of quality and organizational excellence of a software developer rather than the software itself. The approach is similar to TSA’s PreCheck program for travelers who submit to an evaluation of their trustworthiness then benefit from expedited security screening. With Pre-Cert, premarket review is streamlined to allow software to be made available to patients and health care providers more quickly. Once a product is on the market, a robust surveillance system would assure the continued safety and effectiveness of software and developers would be expected to collect and use real world performance information, including feedback from patients and health care providers, to continually improve their devices.
Establishing a new regulatory paradigm for complex medical technologies is no easy task. FDA has already taken important steps to develop Pre-Cert collaboratively with the software industry through a pilot, which was recently expanded beyond the 9 initial participants, many of whom are established medical device manufacturers or software developers.
But the pilot has revealed areas in need of strategic refinement. The biggest challenge I’ve heard from smaller companies is that the benefits of participating in the pilot do not appear to outweigh the costs. The primary cost comes from what one pilot participant recently described as an “audit on steroids,” referring to the premarket excellence appraisal FDA conducts to determine whether a developer has a culture of quality and organizational excellence. These are intensive assessments that startups or the investors funding them may not want a regulator performing without a more direct and immediate benefit. Conversely, it may be easier for a small, nimble company (whether a startup or an established entity) to understand and design solutions that could be difficult for larger companies. For example, while established medical device manufacturers may need to make significant process changes with respect to collecting and using real world performance data, software developers likely already think in terms of using user feedback to improve the next version of their product.
Another challenge with small companies is that many may not develop enough products for Pre-Cert to be a worthwhile investment. Because FDA’s premarket excellence appraisal is intensive, companies may determine it’s not worth the added resource burden for a single product and instead submit themselves and their product to the existing, predictable regulatory review process that gives them the marketing advantage of saying the product has been explicitly approved or cleared by FDA. FDA has maintained, though, that software authorized to be marketed through Pre-Cert will have been found to meet the statutory standard of reasonable assurance of safety and effectiveness; Pre-Cert is simply the mechanism for making such a determination.
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Congress may not agree. A still-unanswered October 2018 letter from Senators Murray, Warren, and Smith to FDA with more than 50 questions about software regulation and oversight outlined concerns those Senators have about the statutory authority, resources required, and public health justification for Pre-Cert, among other related topics. FDA should view their response to the Senators as an opportunity to win over skeptics who question whether Pre-Cert is the appropriate way to support innovation while protecting patient safety.
The biggest risk to the burgeoning digital health industry is no action. That means the regulatory paradigm would stays as it is now, which many companies have said would lead them to abandon plans to introduce novel technologies that patients and health care providers are demanding.
FDA is often characterized as a reactionary agency when in fact the agency is often constrained by lack of authority or funding—both of which come from Congress. While it is prudent for Congress, patients, and industry to openly debate the Pre-Cert’s pros and cons, FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.
Aaron is a Senior Director of ML Strategies. He advises clients on health care policy issues related to medical devices and pharmaceuticals.
Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.
Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research, where he developed the center’s annual budget and provided information to the Congressional Budget Office (CBO) and congressional authorizers. He began his FDA career in the Center for Biologics Evaluation and Research as an information management specialist responsible for data analyses to support FDA policies and programs.
During his tenure with the FDA, Aaron won numerous agency awards, including the Lireka P. Joseph Award for Excellence in Public Health Communication or Education. He also received special recognition from multiple FDA Commissioners, including a June 2017 special citation for outstanding and sustained performance in the negotiation and reauthorization of MDUFA IV and an August 2016 award for contributions to the 21st Century Cures Act.
Aaron earned a master’s certificate in project management from the George Washington University School of Business and is certified by the American Society for Quality as a quality improvement associate.
