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Client Alerts
Your Software May Be a ‘Medical Device’ Subject to FDA Regulation
August 10, 2011

Your Software May Be a ‘Medical Device’ Subject to FDA Regulation

In late July 2011, the FDA released a draft guidance document outlining when certain types of software would be considered a “medical device” subject to FDA scrutiny. Though the guidance is ostensibly limited to “mobile medical apps,” reading between the lines makes clear that all software developers should pay close attention. Public comments on the draft guidance are due by October 19, 2011.

As with all products, the key issue of whether software – mobile or not – is a regulated medical device depends on whether it is intended to (1) diagnose disease or other conditions (e.g., pregnancy); (2) cure, mitigate, treat, or prevent disease; or (3) affect the structure or function of the human body. Intended use may be shown by labeling claims, advertising, website promotions, and even oral statements by the manufacturer or its representatives.

The FDA’s draft guidance lists four broad categories of intended uses of a mobile medical app that would make the software a medical device subject to regulation, as follows:

  1. display, store, or transmit patient-specific medical device data in its original format;
  2. control the intended use, function, modes, or energy source of another connected medical device;
  3. transform the mobile platform into a regulated device; or
  4. create alarms, recommendations, or new information by analyzing or interpreting medical device data from another device.
For more information – including the scope of applicable regulation, who is subject to regulation (and who is not), and examples of software apps that the FDA believes are not subject to regulation – please see our full article available here.

Fish & Richardson has established a website to keep clients up to date on current events in the fast-moving industry of wireless medical technology and telemedicine. Please visit www.fr.com/wireless-medical-devices for future updates.

© Copyright 2011 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this newsletter has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit www.fr.com.
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