Usually in the context of clearing an app, FDA will check to ensure that the software manufacturer is complying with any published special controls. The special controls are typically stated in FDA guidance documents and include, for example:
Guidance for Industry – Wireless Medical Telemetry Risks and Recommendations
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
Device-specific guidance (e.g. glucose monitors)
The submission will need to be based on an appropriate level of validation for the software. If the app is an accessory, the parent device determines the level of validation required. If not an accessory, to determine the validation required, you will need to figure out whether FDA classifies the software as “major”, “moderate” or “minor” “level of concern.”
It’s major if the software directly affects the patient or anyone else such that a failure could result in death or serious injury
It’s moderate if the injuries would be non-serious
An app’s risk and the associated “level” determine:
the depth and degree of hazard analysis and mitigation that is expected
the depth and degree of documentation
what needs to be submitted vs. merely documented
the rigor applied to the verification and validation of the software
The degree to which the device manufacturer’s software development process is scrutinized
And of course, before you can actually bring the product to market, you will need to make sure that your manufacturing meets the FDA requirements for quality systems. In the case of software, those requirements are acutely felt in the development stage as the software needs to be developed under special FDA design controls and in the post-launch stage as the manufacturer deals with product recalls, updates, event reporting, product lifecycle management and so forth.
Conclusion
Those are the basic FDA requirements that apply to bringing an app or other piece of software to market in the mhealth field. Undoubtedly, to those not accustomed to the FDA regulated world, those hurdles might seem high. In the next article, we’ll tackle the benefits and burdens of going through those admittedly rigorous FDA requirements from a business standpoint. In particular we’ll focus on the competitive advantages that can be derived from entering the regulated space, weighed against the cost of achieving those advantages.
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