As Senior Policy Advisor to the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, Bakul Patel advises the Center Director on regulatory policy issues related to medical device software and systems, health information technology, and mobile health. In fact, Patel is the primary author of the FDA's draft guidance for mobile medical applications that the agency issued in July 2011. However, the FDA has come under fire from critics, including Congress, for being slow to finalize the agency's draft guidance for mobile medical apps.
In addition, critics charge that the July 2011 draft FDA guidance on mobile medical apps remains unclear and unpredictable. Without clear guidance, app developers say they don't know whether they should pursue certification of their products as medical devices, sidestep the process altogether and jump into product development or wait for the FDA to issue its final guidance, which is now expected by the end of fiscal 2013. FierceMobileHealthcare spoke with Patel about the FDA's regulatory oversight and review of mobile medical apps as the agency continues to finalize its guidance.
FMH: How is the FDA helping to foster innovation in the field of mobile medical apps?
Patel: We say in the guidance that we want to increase those who are innovating in this area that help people to either self-manage their condition or disease or get better in their health that a way will ultimately prevent disease as things move along and healthcare gets better and gets more patient-centered. By being clear as to what our rules are, we at FDA will provide oversight to those technologies.
Medical devices are those items that are used in diagnosing, treating, mitigating, preventing or curing disease or conditions in humans. If you look at that definition, it's pretty broad. The idea behind the guidance was to clarify and even scale back the definition. In our proposed policy, we're actually scaling back to allow innovation to happen in areas that are more beneficial to patients, while at the same time making sure patients have confidence and are not exposed to risk.
FMH: There seems to be a balancing act between fostering innovation on the one hand and ensuring patient safety. What constitutes a "balanced" FDA approach to mobile medical apps?
Patel: We have a tier system that classifies technology based on patient risk. For example, an EKG machine in a doctor's office, if it is available in a mobile platform, the question is can it provide the same level of confidence that the doctor needs that is found in a traditional EKG machine? The question is how can we balance the benefits that technology and apps, in this case, present to patients, consumers, and doctors as opposed to the risk that those technologies pose. We look at risk as a primary factor, weighing innovation and balancing it with patient safety risk.
FMH: The draft guidance states the FDA's intent to exercise "enforcement discretion" for those mobile apps that do not meet the proposed definition of a mobile medical app. What does that mean?
Patel: By enforcement discretion, we really mean that we're using our authority judiciously to make sure that we only apply it in certain areas that need it. Even though there are types of apps that can be seen as medical devices we will not take enforcement actions.
FMH: Would the FDA regulate the sale or general consumer use of smartphones or tablets?
Patel: No, the law [Food, Drug, and Cosmetic Act] does not allow us and we don't regulate them. For example, we don't regulate the telephone that is sitting on the desk in a doctor's office. That's not what the law was intended for.
FMH: How many submissions to the public docket on the July 2011 draft guidance did the FDA receive? Generally, what was the overall feedback?
Patel: There were about 130 docket entries from individuals or entities. Those 130 entries consisted of about 700 pages of comments that we poured over, carefully considering all the input we received. I can tell you that the overall feedback on the guidance and proposed policy was very positive. People, and we heard this in our public meetings, wanted a lot more clarity. We heard that loud and clear.
FMH: When will the FDA issue its final guidance?
Patel: As we've said in the past, it's a top priority for us. We are working expeditiously to get it out this [fiscal] year. We are hoping that we can do much better than that, but that's our target. We're trying to get it out as soon as possible.
FMH: The continued delay of final regulations on mobile medical applications from FDA isn't making things easy for app developers. Can you sympathize with their predicament and what would you advise them to do?
Patel: Yes, we sympathize. We totally understand their predicament. Trust me, I get those phone calls. My advice to anyone that calls me is to do the right thing. If you are looking at patients as part of what you are developing, you need to put patients first before technology. That would be my advice. As people have done already, they should always contact us if they're unsure.
FMH: How long has the FDA has been regulating medical device software on mobile platforms?
Patel: It's about 10 years now.
FMH: During that time period, how many mobile medical apps has the FDA reviewed?
Patel: We have approximately 100 apps in the last 10 years that we have reviewed. In the last couple of years, we're reviewing about 20 apps per year.
FMH: How many of those have been classified as Class I, II, and III, respectively?
Patel: Most of these apps that we have reviewed and cleared [510(k)] are in the Class II bucket.
FMH: What is the average time it has taken for FDA to review these apps?
Patel: For the apps that we have looked at, we have taken about 67 days on average for reviewing them. However, as a point of reference, there is a statutory timeframe cycle of 90 days for technologies that come to us for pre-market clearance in the 510(k) process.
FMH: With literally thousands of mobile medical apps available on the market, do you worry that a resource-constrained FDA will be able to review apps in a timely manner?
Patel: When you asked the question about balanced approach, this is exactly one of the balanced points as well. First and foremost is patient safety and risk. Making sure people have the right confidence is critical and where medical technologies can be beneficial to patients. Resources is right after that, taking into account how we can be poised to use the knowledge and expertise we have. Even though we have a lot of engineers and software developers that are in the review process, the pyramid of apps that we would review is carved out with the tip of the pyramid only including a small subset that is considered a medical device or actually gets connected to a medical device.
To learn more:
- read the FDA's draft guidance