Mobile Medical App? There’s an FDA Draft Guidance For That.

We’re seeing interest in the Food and Drug Administration’s Draft Guidance, issued July 21, 2011, on the regulation of mobile medical applications which, according to the FDA, pose similar risks as other regulated medical devices. 

We’ll continue to update this reading list as additional commentary and analysis comes in:

Draft Guidance Clarifies How FDA Plans To Regulate Certain Software “Apps” (Ropes & Gray LLP):

“On July 21, 2011, the Food and Drug Administration (‘FDA’) issued a draft guidance document describing how it intends to apply its regulatory authority to certain software applications intended for use on mobile platforms, which the agency terms ‘mobile medical applications’ or ‘mobile medical apps.’

FDA believes that mobile medical apps pose the same or similar safety risks as currently regulated devices performing the same functions. Accordingly, a mobile medical app manufacturer, which includes a person that initiates specifications for an app, will be subject to the medical device regulation. Under the draft guidance, parties to a software development agreement can define their respective regulatory obligations by contract.” Read more»

New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions (Morgan Lewis): 

“FDA stated that its proposed approach is intended to focus only on a small subset of mobile applications, or ‘apps,’ that may impact the performance of currently regulated devices. To this end, the draft guidance provides some principles to apply and examples of the types of mobile apps that would be considered regulated medical devices. However, a number of uncertainties remain as to exactly where FDA draws the line between regulated and unregulated apps.

Thus, although FDA stated intention is to concentrate on those mobile apps that present the greatest risk to patients, ambiguities in the draft guidance may hinder that objective…” Read more»


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