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
Congress saw that
- 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 (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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