The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and other health information technologies (“HIT”).
The subcommittee heard testimony from just two witnesses, Ms. Christy Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (“FDA”), and Dr. Farzad Mostashari, National Coordinator, Health Information Technology, U.S. Department of Health and Human Services.
The witnesses addressed questions raised in the two previous days’ hearings regarding FDA’s role in regulating HIT and MMAs. Some of the key points were as follows:
- Ms. Foreman testified that FDA has prioritized the MMA guidance and intends to issue final guidance by the end of this fiscal year. She reminded the Subcommittee that FDA’s CDRH has been regulating medical device software for decades and MMAs for more than 10 years. She indicated that FDA reviewed its first premarket notification for an MMA in 1997.
- Ms. Foreman also stated that FDA does not intend to regulate smart phones or tablets themselves as medical devices simply because they are used to operate MMAs. Rather, she said that the finalized guidance would set forth a risk-based approach whereby she anticipates that those MMAs (not the actual smartphone or tablet) that perform the same function as a medical device that is currently marketed would have to go through the premarket approval process. She anticipates that this will affect MMAs that fall into the Class II category most directly because Class I devices do not require premarket approvals and she is not aware of any MMAs to date that would be considered Class III devices.
- Ms. Foreman also responded to questioning concerning whether FDA’s current premarket approval process is slowing the pace of MMA innovation. She stated that the current average review time for 510(k) notifications for MMAs is 67 days, far less than the 90 days the agency is allowed by law. She also noted that keeping pace with technology is a constant challenge for FDA and one that the agency is prepared to meet with regard to MMAs.
- Dr. Mostashari spoke more broadly about DHHS programs to expand the use of HIT and electronic health records (“EHR”) technologies in the healthcare setting. He stated that the overwhelming evidence is that healthcare efficiency, quality, and safety is improved by access to better data, which HIT and EHR provide. He acknowledged certain obstacles to the current status of EHR implementation but cited recent statistics that indicate that even at current levels of implementation, these systems are providing benefits to patients and providers.
Ms. Foreman’s comments in particular should have provided some level of comfort relative to the agency’s intentions and a timeframe by which they can expect final guidance. Ms. Foreman explained that because she is not a tax expert and FDA is not a taxing authority, she was not able to answer definitively whether or not MMAs would be subject to the 2.3% excise tax. Many subcommittee members indicated throughout the three days of hearings that they believe that the retail exemption to the excise tax would apply at least to those MMAs marketed to consumers.