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Senators to FDA: Where is mHealth, medical device certainty?

By Jennifer Bresnick

A bi-partisan group of Senators has written to the FDA to ask for certainty and clarification about rules relating to mobile health devices and medical devices.  In a March 18 letter to FDA Commissioner Margaret A. Hamburg, MD, Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Tom Harkin (D-IA), Lamar Alexander (R-TN), Mark Warner (D-VA), and Richard Burr (R-NC) ask the FDA to give developers and business ventures the information and clarity they need to avoid confusion about the long-awaited regulatory policies released late last year.

“We are writing to ensure that the regulatory oversight by the FDA over mobile medical applications remains current with changing technologies,” the letter says.  “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.”

The Senators have asked the FDA to respond within three weeks to the following list of questions.

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?

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?

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? 

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?

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?

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?

Are there additional legislative tools that the FDA needs to better oversee the regulation of medical mobile applications?

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,” the letter concludes.  “We hope that we can work together to ensure efficient, predictable, and proper FDA oversight in this innovative and fast-paced field.”

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