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# ‘Total Product Lifecycle’ in Cyber Guidance
- URL: https://www.fdaweb.com/total-product-lifecycle-in-cyber-guidance/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151573

FDA’s latest cybersecurity draft guidance underscores the total product lifecycle nature of cybersecurity considerations for medical devices, including premarket device submissions and deployment mitigations for older legacy devices that were not built with security in mind. That’s the assessment of CDRH Office of Strategic Partnerships and Technology Innovation director **Suzanne Schwartz** in an [interview](https://www.medtechdive.com/news/fda-draft-cybersecurity-guidance-requirements/621872/?ref=fdaweb.com) with *MedTechDive*. While the agency says the guidance should be viewed only as recommendations unless specific regulatory or statutory requirements are cited, Schwartz acknowledged that manufacturers choosing an alternate approach “would have to really provide pretty solid, ample justification” as to why their approach satisfies the legal requirements for meeting safety and effectiveness in quality system regulations.

“Where we have teeth here,” Schwartz said, “actually is manufacturers recognize that \[following this guidance\] is likely to be their best way to get a product on the market. Not following the guidance is going to create greater, probably, complexities or potential hardships as far as addressing questions that will come up. That means potentially delays.”

The agency is accepting public comments on the guidance until 7/7.