6-hr Virtual Seminar-FDA Software Regulation, Cybersecurity Requirements and Interoperability

Casper (Cap) Uldriks

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For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for device evaluation.

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.

  • FDA’s risk-based regulatory strategy
  • Cybersecurity
  • Interoperability
  • National Institute of Standards and Technology
  • Voluntary standards
  • Software premarket design requirements
  • Software recall

Part I

FDA’s regulatory approach

  • Types of Software 
  • Risk classification based on use and hardware
  • Office of the National Coordinator (ONC) for Health Information Protection
  • National Institute of Standards and Technology
  • FBI Assessment of FDA and Device Manufacturers
  • Premarket Design Controls
  • Postmarket disasters – ransomware, managing public disclosures

Part II

Cybersecurity

  • Device vulnerabilities: malfunction and failure
  • Pre-emption design
  • Latent malware/virus
  • Post-event management

            o Corrective action for software
            o Disclosure to users

  • National Institute of Science and Technology Guidance

Part III

Interoperability

  • Compatibility by design

           o Hardware
           o Software

  • Labeling

            o Precautions
            o Instructions for use

  • Use of Voluntary Standards
  • Failure management / follow up

  • Regulatory Affairs
  • Quality Assurance
  • Software Design Engineers
  • Manufacturing
  • Complaint Dept.
  • Hospital Risk Dept.
  • Own label marketers 

Webinar Events
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Training CD-USB

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Recorded video

Recorded video session

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Speaker: Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.


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