Mobile medical apps

On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives.  The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.

The bill creates a regulatory scheme based on three newly defined categories of software—“medical software,” “clinical software,” and “health software.”  Although the bill proposes to carve out “medical software” from the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321) (“the Act”), medical software would be subject to the same regulatory requirements as medical devices under the Act.  In contrast, “clinical software” and “health software” would not be subject to regulation under the Act.

The bill defines medical software as software intended for human or animal use that is intended to be marketed (1) “to directly change the structure or any function of the body of man or other animals;” or (2) for “use by consumers and makes recommendations for clinical action that (i) includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider; and (ii) if followed, would change the structure or any function of the body of man or other animals. . . .”  Medical software does not include software “whose primary purpose is integral to the functioning of a drug or device” or software that is a “component of a device;” such software presumably would continue to be regulated as part of the “parent” device or drug product.
Continue Reading House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) about its implications.

Commentators observed that the letter appeared to be intended, in large part, as an educational tool for industry.  As such, it’s appropriate to ask:  what lessons should industry draw?  Although single enforcement actions do not always serve as reliable predictors of future actions, the letter offers a handful of key takeaways:
Continue Reading Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

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