House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming

by Dan Vorhaus

[Cross-posted from Genomics Law Report]

Digital Hospital - 262 wideThree days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).

The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.

A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.

In testimony before Congress, which was supported by a formal written response to the House subcommittee’s inquiry (pdf) as well as a recent FDA blog post, the FDA provided substantial additional clarity regarding its regulatory intent and the timeline for finalized mHealth regulatory guidance. Here are the highlights:

Timing. According to Christy Foreman, Director of the Office of Device Evaluation at the Center for Devices and Radiological Health, the draft guidance published by the FDA in 2011 is expected to be finalized in the coming weeks. When pressed for a more specific deadline during the hearings, Foreman promised final guidance by the end of the FDA’s fiscal year (i.e., September 30th).

While useful for planning purposes, remember that there are those within Congress and the industry who might like to see mHealth oversight shifted to another area of the federal government, or removed from federal regulatory review altogether. Thus, while Foreman’s declaration that the final guidance is imminent is certainly noteworthy, it is not conclusive.

Scope. In keeping with its draft regulations, the FDA has given every indication that it is interested at this time in regulating only “a small subset of mobile apps” – those that meet the definition of a device under Section 201(h) of the Food, Drug, and Cosmetic Act (FDCA) “and are intended for use as either: (1) an accessory to a regulated medical device, or (2) transform a mobile platform into a regulated medical device.” (Per FDA’s written comments to the House.)

While this narrow scope, and the FDA’s other comments at and after the House hearings, seem to clearly rule out certain mobile devices and platforms – iPhones and iTunes, for example – as regulatory targets for the time being, there is still likely to be a considerable regulatory gray area for mHealth developers and investors to navigate. In that vein, the FDA notably referred all questions related to the applicability of the Affordable Care Act’s 2.3% medical device excise tax to the IRS.

Statistics. The FDA also provided some statistics about its mHealth regulatory activities to date, presumably to help bolster its claims of targeted and efficient mHealth regulation. In response to one specific question from Congress, the FDA’s written response (pdf) disclosed that over the past decade the agency had received “approximately 100 [medical device submissions] for mobile medical apps” and that, during 2011 and 2012, the “average total time from submission to FDA decision was 110 days.”

While that timing is in line with average FDA review times for 510(k) submissions — which apply to moderate risk devices and seem likely to govern many newly regulated mHealth applications — it should not be taken as a complete measure of the length of the regulatory process, since it ignores important pre-submission activities and agency meetings.

Additional Information and Next Steps. For those interested in more on the Congressional hearings, full video and written testimony are available through the Energy & Commerce Committee’s website and excellent live-blogging and other coverage was provided by mobihealthnews.

With the hearings over, the mHealth community will now wait for the next development which — barring an unexpected burst of activity from Congress or another federal agency (and there are plenty of options, as we have discussed) — will likely be final mobile health application guidance from the FDA later this year.

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