New FDA Software Guidance Published to Help Developers Identify if their Software is considered a Medical Device in the USA.

by | Nov 29, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS

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FDA has recently released and updated several final guidance documents for medical device software, which will help software developers identify if their software is considered a medical device in the USA.

The first updated final guidance “Policy for Device Software Functions and Mobile Medical Applications” refines FDA’s approach to what software and mobile app functions it considers to be “Software as a Medical Device” which requires control and oversight according to FDA regulations.

This guidance outlines that some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices. This means that meaning FDA does not, at this time, intend to enforce FDA medical device requirements.

It clarifies that FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.

It includes examples (non-exhaustive) of;

–        software functions that are not medical devices,

–       Software functions that are low risk software medical devices. but not intended to be enforced as such by FDA

–       Software functions that are higher risk and a focus for FDA regulation.

The second new final guidance document “Clinical Decision Support Software” provides assessment information and examples of what decision support features need to be considered in determining whether the decision support feature meets the definition of a ‘medical device’ according to the FDA, and requires regulation.

According to FDA, software which can be demonstrated as meeting all 4 criteria outlined in the guidance document and can be considered “Non Device Clinical Decision Support”. The guidance document also provides several examples of software which can be considered “Non Device Clinical Decision Support”, and several examples of software which FDA considers is as Medical “Device Software Clinical Decision Support” functionality, which requires regulation as a medical device in the view of FDA. This guidance should be read in conjunction with the guidance referred to above if the software is not excluded.


In the use of enforcement discretion and publicly available guidance, FDA is continuing to show itself as being a favourable regulatory regime for digital health software developers who integrate innovative lower risk medical functionality into their software.


IMED can assist you in assessing your software against FDA requirements, and provide support in getting FDA clearance for your medical device or software to be sold into the US market.


Can we help you? Why not get in touch at or by calling 01295 724286 and find out?


Tim Bubb

Tim Bubb

Technical Director

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