Guidance for Off-The-Shelf Software Use in Medical Devices

logic paths and complexities of OTS Software components make it important to know that designstructure or logic elsewhere in the system is not impacted. This means a full system regressiontest should be performed. Results of these validation activities should be documented.The submission should answer the following questions:• Do test reports provide objective evidence that identified OTS Software component hazardshave been addressed?• Do test reports provide objective evidence that all identified SYSTEM hazards have beenaddressed?• Has a system regression test been performed?5.5.4 InstallationChanges in a product baseline structure resulting from the integration of new OTS Softwarecomponents may impact installation requirements. This impact can range from minordocumentation changes to field upgrades. The reviewer should ascertain the impact of OTSSoftware component changes on fielded products.The submission should answer the following question: What is the impact of new OTS Softwarecomponents on fielded medical device products?For example: Do new OTS Software components correctly operate within the specifications ofmedical devices currently fielded?5.5.5 ObsolescenceRapid technology changes, economics, and market demand are shrinking product life spans. Adirect consequence of these phenomena is that an OTS Software component today may not existtwo years from now. Short life spans are a particular characteristic of software because it isrelatively easy to change. Obsolescence of OTS Software components can have significantimpact on regulated products because the device manufacturer may lose the ability to properlysupport fielded products. The sponsor needs to support fielded medical device products withOTS Software components.The submission should answer the following questions:• Will the old OTS Software component still be available for fielded medical devices?• Is there a retirement plan for OTS Software components to be replaced/eliminated?• Do new OTS Software component(s) replace fielded components?5.5.6 Change controlThe submission must identify the product to be considered. Therefore, the product configurationprovided should specify:OTS Software Guidance, Final page 25