Digital health pre-certification
The FDA is advancing a regulatory approach to digital health called the Digital Health Pre-Certification (Pre-Cert) program. Currently in pilot-phase testing with nine companies, the approach aims to make reviews of digital health products more efficient by rewarding those companies who have been assessed and evaluated by the FDA as having a “robust” culture of quality and organizational excellence for the purposes of developing digital health products.
Those companies will be permitted to have their products reviewed in a streamlined way, which would reduce the review time for the product by focusing on what the product is rather than what it does. This would then be paired with real-world health analytics, product performance analytics and user experience components, requiring the company to track how the product is being used and quickly address issues.
The FDA has published draft guidance that would make it easier for companies to include multiple functions in their mobile applications. Some devices, for example, may include a complex prescription function intended to help diagnose disease, like an algorithm that detects signs of cancer from a photo, as well as some unregulated functions intended to benefit the end user, such as a step counter or diet tracker.
Rather than treating all of the functions of the device as a single, combined entity, the FDA will instead treat them as separate. This will permit a regulated device to include otherwise unregulated or minimally regulated functions without subjecting them to rigorous oversight by the FDA. This could help companies to develop, upgrade and update more full-service applications without having to worry that each added function would trigger new regulatory requirements. It could also help companies to develop products in an iterative manner, allowing them to incorporate patient feedback into developing more useful products.
The FDA has proposed a substantial change in the manner in which it will subject pharmaceutical companies’ drug-use-related software to regulatory oversight. Such applications include companion mobile applications that help consumers to use a company’s prescription drug products in accordance with the FDA-approved labeling.
Previously, companies could be required to submit these applications for approval under the premarket notification pathway, also known as the 510(k) pathway, if they were not exempted. Under the new proposed change, the FDA would instead treat such applications as promotional labeling, a much lower standard of review that does not require FDA approval prior to dissemination.
This could greatly increase incentives for companies to develop digital companions for their products by lowering the regulatory hurdles for entry.
Digital labeling for over-the-counter drugs
In July 2018, the FDA released draft guidance saying the agency is willing to allow the approval of over-the-counter drugs that it would otherwise not approve, as long as they have the right type of product labeling, which could include digital labeling on smartphone apps accompanying the drug. Under the FDA’s approach, these digital tools, primarily mobile applications, would help consumers choose OTC drugs that would be best for them and avoid drugs that could harm them. Companies would be required to conduct studies of the application to ensure it correctly steers consumers to or away from its product.
The FDA said it believes the new approach could support the approval of a “wider range” of nonprescription drug products than is on the market, which could benefit pharmaceutical companies with long-marketed, generally safe products with minor safety concerns that have prevented them from obtaining OTC approval.