As was reported previously on our sister blog, InsideMedicalDevices, the regulation of mobile medical apps continues to be an issue on Congress’ radar. Last week, the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices, how technological advancements benefit patients, ways to ensure that innovation continues, and the Obama Administration’s perspective and future plans with regard to regulation of medical apps.
Christy Foreman, Director of CDRH’s Office of Device Evaluation, spoke on behalf of FDA. She defended as a “narrowly tailored approach” the FDA’s proposed policy toward regulating mobile medical apps announced in the 2011 Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications. (We discussed the draft guidance in a client alert and a recent article.) Ms. Foreman also stated that the final version of this guidance is in the final stages of internal review and is expected to be issued before the end of fiscal year 2013. The final guidance will address commenters’ requests for clarification and provide additional examples of regulated apps. Ms. Foreman also deflected questions relating to the medical device tax, stating that taxes are not within FDA’s jurisdiction.
In addition to Ms. Foreman’s testimony, FDA provided a letter to the Energy and Commerce Committee responding to questions posed by committee members on March 1. The letter explains that “actual use” will not be a factor in determining whether a mobile platform or device–such as an iPhone–will be regulated by FDA as a medical device. The letter also provides some interesting statistics on FDA’s review of mobile apps to date. According to FDA, it has reviewed approximately 100 pre-market submissions involving mobile medical apps. In 2011 and 2012, FDA has taken approximately 67 days to review 510(k)s for these devices, with an average total of 110 days from submission to FDA decision. Those statistics may be a surprise for some, as the media’s coverage of mobile apps regulation often has focused on the delays associated with regulatory review.
Stakeholders should stay tuned for future developments: House Republicans have named mobile medical apps among their life sciences policy priorities.