Washington, DC – A bipartisan group of senators is urging the FDA to provide further clarity and transparency in its policy regarding medical mobile apps. 

Senators Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr urged the Food and Drug Administration (FDA) to further clarify rules for medical software application developers to promote innovation and keep consumers safe in light of changing technologies. 

In a joint letter to the FDA, the senators stated, “It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation.”

“While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.  We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike.”

In 2013, the FDA issued final guidance for oversight of medical mobile apps.  The lawmakers are seeking further clarification about current policies and oversight of medical mobile apps and medical software and asked the agency to continue working with Congress to ensure proper oversight over this innovative and fast-changing technology. 

Full text of the letter is below:

March 18, 2014

Dear Commissioner Hamburg:

We are writing to ensure that the regulatory oversight by the Food and Drug Administration (hereafter “FDA” or “Agency”) over mobile medical applications remains current with changing technologies.  It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation. 

The Food, Drug, and Cosmetic Act defines a medical device as:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, and/or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

In the final guidance clarifying FDA oversight over health care-related mobile apps, the FDA used a risk-based approach in defining what the agency considers to be a mobile medical application, with the agency’s efforts concentrated on high-risk medical software.  Given that a large number of medical mobile applications could be actively regulated under the statute using this definition, we appreciate the FDA’s decision to use a risk-based approach to regulation.

While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.

We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike.  Additionally, we ask that you provide responses to the following questions about current policies and oversight over mobile medical applications and other medical software.  Please respond within three weeks of receipt.

1. Compared to current FDA guidance, what impact would Congress establishing categories of medical software in legislation have on the FDA’s oversight of medical mobile applications?
2. We understand you have set up an e-mail address to answer questions about FDA’s regulation of specific mobile medical applications. How many e-mails have you received to date and what is FDA’s average response time in calendar days?
3. In addition to the dedicated e-mail address, what policies and practices has DFA established to further assist innovator companies that are not familiar with FDA’s regulations and requirements applicable to medical device manufacturers? 
4. What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?
5. 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?
6. When a medical mobile application presents a novel function that has never been classified by the FDA, what procedures are used to determine if and how that application should be regulated by the FDA?
7. How has the FDA been coordinating with the Office of the National Coordinator and Federal Communications Commission to address the recent FDA Safety and Innovation Act working group’s concerns over interoperability?
8. Are there additional legislative tools that the FDA needs to better oversee the regulation of medical mobile applications?
9. What approach does the FDA use to regulate complex medical software with multiple and separate functions?

We thank you for your continuing cooperation in addressing important concerns about certainty and consumer safety in the medical software industry.  We hope that we can work together to ensure efficient, predictable, and proper FDA oversight in this innovative and fast-paced field.

Sincerely,