For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.
To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.
Navigating unclear boundaries
Last February, the FDA issued new guidance on mobile medical applications. In that document, the agency defined three main categories of apps:
- Products that will be regulated. These apps could harm a patient if they don’t function correctly — for example, an app that calculates the radiation dosage for a cancer patient. These products require clinical validation prior to approval.
- Products for which the agency will exercise “enforcement discretion.” The regulations still apply to these apps, but the FDA has chosen not to enforce them at this time because the products are lower-risk. An example is a simple diary app that allows patients to log and organize their health data.
- Products that will not be regulated. These apps might be used by patients or providers but aren’t classified as medical devices — for example, an app that determines billing codes for reimbursement of health care visits.
One particularly ambiguous area involves clinical decision support (CDS) tools. These products gather and process information to help patients and providers make medical decisions. Some CDS apps may be regulated, while others may not.
In this complex environment, companies should not assume that their product is unregulated — or that simply reading the guidelines is enough to interpret them correctly. Instead, they should seek guidance by working with an expert in the area or holding discussions with the FDA. Since mobile health products are fairly new, talking to the agency early in the development process is recommended.
Key design and development considerations
Critical design decisions can affect the product’s regulatory status. For example, consider a company that has developed a module for managing diabetes. If the module is part of a larger software platform, using a certain architecture could cause the entire platform to be regulated (instead of just the diabetes component) and put an undue regulatory burden on the product. In these situations, the best strategy may be to work with a mobile health regulatory expert to propose a solution and then confirm that the FDA agrees.
Some companies assume that the FDA will not allow an iterative or agile development approach. But the agency does not dictate design and development methodology. Companies should consult guidelines from standards development organizations to determine how to comply with regulations, such as documentation requirements, while still following an agile process.
A proactive approach
Some basic precautions can reduce the risk of encountering regulatory surprises. If a company has a product that falls in the “enforcement discretion” category and does not plan to add features that would push the app into regulated space, they should take care to stay well behind the boundary line. For example, the company should not make any marketing claims similar to those for medical devices, such as promises to diagnose or cure a disease.
If a product is currently in a regulatory grey area, the company can implement a lightweight quality system. For instance, the FDA requires regulated apps to have a design history file that records all the product’s requirements and testing. If the agency changed its guidelines and the product became regulated, recreating those documents would be challenging. Companies can avoid such problems by meeting some quality system requirements that would be difficult to address retroactively.
For companies who are developing products in the regulated product category, a well-designed clinical trial that captures the essential data to support validation as well as a sound quality system are essential for success.
Mobile Health | Going global
Finally, companies will need to carefully consider international regulations. At a high level, many countries’ guidelines are similar and aim to protect public safety. But the details vary, and the same product could fall into different regulatory classifications depending on the country. In addition, finding the relevant guidelines can be difficult in countries such as China and Japan. Working with an expert who is familiar with those regions can help ensure that the company meets requirements around the world.
Our mobile health solutions include regulatory consulting and validation services to help companies succeed in the fast-growing mobile health field. With partners such as Navigant, which has specialized expertise in medical device regulations, we can ensure that clients identify the right pathways for validation, registration and approval.