The september release of the FDA Policy for Device Software Functions contains important additions to the orginal 2013 policy document. Read the document by clicking the FDA logo in this post.
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”) or on general-purpose computing platforms. Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms, the FDA is issuing this guidance document to clarify the subset of software functions to which the FDA intends to apply its authority.
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