FDA’s Medical Device Software Regulation & Compliance

FDA’s Current Change in Software Regulation and Future Cybersecurity Concerns for Digital Health Functions


  • 21st Century Cures Act impact

  • Software that is no longer regulated by FDA

  • Changes in premarket requirements

  • Voluntary controls as a premarket shortcut

  • Postmarket reporting options

  • Digital Health Initiative – FDA clearance not required and new cybersecurity expections


Congress saw that FDA struggles to regulate software.  So, Congress removed some software from FDA’s jurisdiction.  The FDA must now revise its premarket and postmarket regulatory, including mobile apps.  Using voluntary standards in premarket submissions will make the process more efficient and effective.  Even more dramatic, FDA’s new Digital Health Initiative assigns FDA’s premarket clearance determinations to software manufacturers. Moving forward, cybersecurity development and management for FDA’s Digital Health program is not well defined, which leads Digital Health technology quite vulnerable for new reasons.  The approach places trust and quality at the core of the process.  Overall, the burden of software regulation for industry and the FDA has eased up. Those changes will save time and money for everyone involved.

Who should attend?

  • Healthcare institutions – electronic healthcare records managers (EHR)
  • Clinical  application users, such as mobile treatment programs
  • Medical device manufacturers
  • Regulatory affairs directors
  • Software design engineers

Casper Uldriks


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 Radio-logical 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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