Can a manufacturer or distributor market software for use with an ASR?
If an ASR manufacturer chooses to market software for use with its product, then the products together would not be considered an ASR. Software does not meet the definition of an ASR. FDA views marketing practices that directly suggest or state that particular software is needed to achieve a function of an ASR to cause the ASR part of the combination to fall outside of the ASR definition because the ASR would now be intended for use with the software. As a result, FDA’s view is that ASR manufacturers should not promote, sell, or otherwise distribute software for use with a particular ASR.
