DECEMBER 20218 MANUFACTURING TECHNOLOGY INSIGHTSFDA Perspectives and Guidance on Software as a Medical Device (SaMD)By David Pudwill, Senior Director, Regulatory Affairs, ConvaTecThere's a lot of software-related activity happening at FDA, with the recent formation of FDA's Digital Health Center of Excellence and the release of an "Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan" in January 2021. Here's a primer on what SAMD is, what SAMD is not, and how to navigate the changing regulatory landscape in this area.First, it's helpful to categorize what SaMD is not. Section 3060 of the Cures Act created a function-specific definition, and as such, the functions excluded from the device definition under section 520(o) of the FD&C Act are independent of the platform on which they might run. The functions that are excluded are: (A) for administrative support of a health care facility...(B) for maintaining or encouraging a healthy lifestyle...(C) to serve as electronic patient records...(D) for transferring, storing, converting formats, or displaying ... data and results, findings by a health care professional...and general background information...unless such function is intended to interpret or analyze...data, results, and findings...Many Standalone Software Functions are Not Medical Devices, or FDA Does Not Intend to Enforce Requirements. FDA has provided a number of examples of the types of software functions that fall into these categories in a general wellness guidance document. While general wellness claims are not specific to software products, four illustrative examples of general wellness software functions are included in FDA's guidance document. The guidance also clarifies, in a non-software example, that how products are regulated by FDA is based on intended use (and the same is true for software products): Illustrative Example 6: A product is intended to mechanically exfoliate the face, hands, and feet to make the skin smoother and softer. The product cannot be used in a manner that penetrates or pierces the skin. This claim relates to self-esteem and does not refer to a specific disease or medical condition, and thus is a general wellness claim. In addition, the product is non-invasive as it does not penetrate the stratum corneum and the technology for exfoliating the face does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low-risk general wellness product. Note: However, if the product is intended to exfoliate the skin in order to enhance the delivery of a topically applied product containing one or more active pharmaceutical ingredients through the stratum corneum, the product would be invasive. Therefore, the product would not be a low-risk general wellness product.Second, it's useful to consider the description from the International Medical Device Regulators Forum (IMDRF), provided in the Final Document: Software as a Medical Device (SaMD), and incorporated into a FDAguidance document: "A SaMD can best be described as software that utilizes an algorithm (logic, set of rules, or model) that operates on data input (digitized content) to produce an output that is intended for medical purposes as defined by the SaMD manufacturer. The risks and benefits posed by SaMD outputs are largely related to the risk of inaccurate or incorrect output IN MY OPINIONIN MY OPINIONDavid Pudwill
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