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as a “narrowly tailored approach” the FDA’s proposed policy toward regulating mobile medical apps announced in the 2011 Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications. (We discussed the draft guidance in a client alert and a recent article.)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.
Continue Reading FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year