Congress Moves To Clarify FDA mHealth Oversight

9-23-2013 10-03-55 PM

A bipartisan group of six senators have sent a letter to the FDA in an attempt to further clarify the organization’s stance on mobile medical app regulation. The FDA issued its final guidelines on mHealth apps in September 2013 and the regulatory framework put in place largely won the approval of entrepreneurs and developers.

In the final guidelines, the FDA states that premarket approval will only be required on apps “intended to be used as an accessory to a regulated medical device”, or that “transform a mobile platform into a regulated medical device.” Examples of regulated apps include diabetes management apps like WellDoc’s Bluestar app, or ECG viewers like AirStrip.

The letter was signed by Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.). According to the authors, the letter was written to help ensure that “innovation is not stifled through uncertainty or over-regulation,” and to help avoid “stakeholder confusion over how a wider range of medical software might be appropriately regulated.” The letter applauds the FDA’s risk-based approach to regulation, but goes on to push for additional clarity and hints at forthcoming legislation that could potentially restrict the FDA’s regulatory authority over software.

In the full text version of the letter, FDA is asked to evaluate and directly respond to nine questions that the senators believe require additional clarification, including:

  • What impact would Congress establishing categories of medical software in legislation have on the FDA’s oversight of medical mobile applications?
  • What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?
  • How is the FDA determining what types of medical software updates, even minor updates, change the function of or add a function to the medical software and would require FDA review?

In a sign that senators have learned from their past dealings with the FDA on the issue of medical app guidance, they explicitly state in the letter that responses to the questions are due back to Congress within three weeks. The FDA delayed publication of its mHealth guidelines for months in 2013, leading to Congressional hearings over what was causing the delay. With a built in timeline, the letter becomes much more effective because it means that further clarification is just around the corner.

There are currently two bills in Congress that attempt to limit the FDA’s regulatory authority over software. The first, introduced in the House in October 2013 by Rep. Marsha Blackburn (R-Tenn.), was written to formally name and define different types of software operating within the healthcare market, and to then clarify the regulatory oversight the FDA would have over each. That bill is currently referred to the subcommittee on Health, and has attracted 28 bipartisan co-sponsors.

The second bill focused on the FDA’s oversight of software was introduced in the Senate just last month by Deb Fischer (R-Neb) and Angus King (I-Maine). It has a total of three co-sponsors and focuses on formally describing the FDA’s regulatory authority over health IT.

If legislative action is eventually taken, the final product will likely incorporate tenets from both the House and Senate versions of the bill.


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