2022 FDA Premarket Cybersecurity Guidance

FDA has released a new draft of Premarket Cybersecurity in Medical Devices:  Quality System Considerations and Content of Premarket Submissions.  Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices that are network-enabled or contain other connected capabilities.”

You can download the guidance here: Premarket-Cybersecurity-Guidance draft-April-2022

Cybersecurity in Medical Devices

Quality System Considerations and Content of Premarket Submissions

Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance document is being distributed for comment purposes only.
Document issued on April 8, 2022.


  1. Secure Product Development Framework (SPDF)
    FDA is using the terminology of a “secure product development framework (SPDF) which they define as “a set of processes that help reduce the number and severity of vulnerabilities in products.”  Each manufacturer should consider how security fits into the overall product development lifecycle – not just an activity prior to or close to the time of a product release to the field.  To ensure this happens, the quality management system (QMS) would likely need security related activities institutionalized into SOPs and design and development plan (DDP) templates.  As with any quality related activities, proper evidence in documentation and records would be expected to make the quality argument.
  2. Design for Security
    Obviously the QMS should have required design activities for security.  This translates into security related activities in:

    1. Risk management
    2. Product requirements and software requirements
    3. Design review and design verification
    4. Design validation
      The guidance lists these clear security objectives:

      1. Authenticity, which includes integrity
      2. Authorization
      3. Availability
      4. Confidentiality
      5. Secure and timely updatability and patchability
  3. Understanding the Risks
    A common pitfalls is to begin security activities without first understanding the role security will play based on the intended use of the  product.
  4. Transparency
    End users must be aware of any vulnerabilities and how it might affect their use of the product.  Adopt a mindset that information should not be withheld or hidden from end-users – involve them in the overall security equation.
  5. “Living” document
    The cybersecurity risk analysis is a “living” document.  One would expect the revision history (or new reports) to occur periodically as more information is gained on the threats and on the “real world” effectiveness of the cyber controls.

What actions do we recommend?

In response to this FDA Premarket Cybersecurity Guidance, we would recommend that you evaluate your design controls process and software development lifecycle process against this guidance document.  Do you have the expected activities?  Do you have the proper documents and records to perform adequate accident or breach incident investigation?

We can help.  We can review your procedures and provide recommendations for a more robust SPDF.

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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