“[Final guidance] should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight and Investigations Subcommittee on March 21, 2012. Ms. Foreman’s testimony can be viewed at the committee website, here.
In July 21, 2011, FDA released draft guidance to clarify the types of mobile apps to which FDA intends to apply its authority. Therein, FDA defines a “Mobile Application” as “a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.” A “Mobile Medical Application” is defined as a Mobile Application that meets the definition of a “device” in the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321) and either is used as “an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.” Although FDA touts its draft guidance as “narrowly tailored,” as demonstrated by the 131 comments received, industry begs to differ. Nearly two years later, FDA has yet to issue final guidance.
Industry testimony at the March 21 hearing was consistent – final guidance is necessary to quell regulatory uncertainty. Most witnesses appeared to have a sense of urgency, which is understandable considering that there are 27,000 mobile health applications (and 500 new apps per month). Bradley Thompson, general counsel for mHealth Regulatory Coalition, remarked that, without final guidance, business “is frozen on the sidelines waiting.” Moreover, the industry witnesses agreed that the draft guidance is unclear because it does not focus on types of mobile applications that it will regulate or even which applications will require a pre-market approval.
Ms. Foreman’s testimony added little information beyond that which is available in the draft guidance. She recognized and reiterated the definition of Mobile Medical Application in the draft guidance, presumably indicating that there will be no change in the definition. She did, however, offer some Agency insights, stating that “FDA’s proposed mobile medical apps policy would not”:
- regulate the sale or general consumer use of smartphones or tablets;
- require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes; nor
- apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.
The above information may not be seen as helpful by many stakeholders. In comments to the proposed rule, many stakeholders seem more interested in what will be regulated, as opposed to what will not be regulated. Although there was no further elaboration on what will be regulated, Ms. Foreman recognized that “clarity” is necessary for industry and “final guidance will provide additional clarity and examples.” Further the final guidance will “refine” FDA’s approach and further “narrow” the regulatory scope.
Ms. Foreman also touted the efficiency of FDA’s 510(k) process, stating that based on “performance over past three years, all mobile apps reviewed in the 510(k) process averages 67 days.” Yet, since 1997, FDA has only had one-hundred Mobile Medical App 510(k) submissions.
Although Ms. Foreman’s testimony added little to the public record, there is still hope for industry that, perhaps, the final guidance will “fill in the blanks” to end the paralyzed state of regulatory uncertainty.