Wherever you are in your product development lifecycle,
Sterling can help.
Author: Dan Sterling | Date: July 7, 2015
The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly talking about the FDA’s role in regulating the growing wave of new medical device apps in the market.
The FDA has provided guidance and regulations for the medical device apps space. For example, a mobile app is considered a medical device if it meets the definition of “device” in 21 CFR 210(h), and is intended “to be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device.”* However, there are gray areas when it comes to the FDA’s flexibility over what mobile applications it intends to regulate. Some devices will be regulated and some will not, and the FDA is the sole authority to determine where the boundary will fall.
As is the case with innovation, as soon as regulations for a type of medical device are in place, another product comes to market that once again breaks the mold. Therefore, it is virtually impossible for the FDA to cover every application type in such a fast paced environment. By necessity, the FDA can only provide guidelines and then expect industry to determine the best way to ensure compliance.
Yes, there is evidence that opposition to the FDA is growing. But this not for lack of FDA action in the medical device apps space. It is because those who are not accustomed to regulation simply do not like to add the cost structure of regulation to their bottom lines.
Uncertainty is another driving force behind increased opposition to the FDA’s role in the medical device apps space. Congressional bills present and past, such as The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act and the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, can actually increase uncertainty by making the regulatory landscape more complex, rather than leaving it to the FDA to do its job.
Both bills fell short of becoming law. But debate over the FDA’s level of oversight of medical device apps continues even today. In fact, the SOFTWARE Act was re-introduced on May 18, 2015**.
Additionally, as a result of the rapid progress and evolution of new technologies in the medical device space, there are some within the government calling to greatly limit the FDA’s involvement in the regulation of medical device apps. Their argument is that the types of medical device apps coming to market today are not really medical devices at all. In other words, these apps shouldn’t have to go through the rigorous FDA approval process to help ensure that they are safe and effective.
Let’s take the PROTECT Act for example. One of its aims was to keep FDA policies from slowing down the development pace of ‘low risk’ medical software devices by handing off their oversight to the National Institute of Standards and Technology (NIST). This runs counter to the FDA’s existing final guidance document on mobile medical devices that describes an approach that extends oversight to any diagnostic-related product that could impact a patient’s healthcare decisions.
There are several problems with removing apps from the FDA’s purview. Any type of software that serves as an aid to clinical diagnosis – such as one presenting patient health records or offering a level of specialized information that could influence how an individual manages their own care – is considered to be critically important to patient care.
Another concern is that new legislation could lead to the deregulation of all medical device apps allowing manufacturers to save costs by skirting the edges of regulation during the development of software products such as MRI scanners; for example, by moving software currently located ‘on’ scanner hardware to a mobile device.
Proponents of the former PROTECT Act wanted to hand off oversight of ‘low risk’ medical software devices to the NIST. It’s worth noting that the NIST currently possesses no investigatory powers. Some industry representatives expressed their concern at the potential for a fresh set of ‘standards’ being developed and enforced. With the addition of a fresh set of standards being introduced, you would also have to anticipate a fresh set of investigators being added to the NIST roster to ensure enforcement.
It could be argued that spreading regulation across two agencies would lead to further regulatory backlash. One of the biggest concerns with sharing regulation oversight of medical device apps across multiple government agencies is that it would add uncertainty for some apps that could fall in between. Envision a scenario where you submit to one agency and they reject forcing submission to the other agency with potentially a great deal more rigor required, causing a big delay right when cash strapped startups think they’re nearing the finish line.
The inefficiencies in present legislation similar to the PROTECT Act and SOFTWARE Act could introduce the potential for patient health to go unprotected in a rapidly growing area of medical technology. It is better to know what you are dealing with from the onset and plan accordingly using a proven medical device software approach.
See how the Sterling Medical Devices approach can help bring peace of mind in the FDA approval process, allowing you to focus more on achieving your future business goals.
* “Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff,” U.S. Department of Health and Human Services Food and Drug Administration, February 9, 2015
** “Green, Blackburn reintroduce SOFTWARE Act,” The Humble Observer, May 19, 2015
February 18, 2021
September 8, 2020