Tag Archives: medical device software

Gabe Siftar and Matt Nowell

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

By Gabe Siftar, Matt Nowell
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Gabe Siftar and Matt Nowell

The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.

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FDA Releases Final Guidance on Premarket Submissions for Device Software Functions

By MedTech Intelligence Staff
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“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.

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