Why Should You Attend:
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. The approach places trust and quality at the core of the process.
Attend this webinar to understand changes in FDA’s regulatory program for software which were in part, initiated under the mandate of the 21st Century Cures Act. More over FDA is relying more on the use of voluntary standards and the guidance provided by the National Institute of Health, especially for issues concerning cybersecurity and software interoperability. FDA’s regulation of software will likely keep changing as software technology advances.
If you are a Medical device manufacturer or Retail marketer of software or Healthcare institution it is must to learn below best practices to be in tune with changing requirements.
Areas Covered in the Webinar:
Who Will Benefit:
Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in 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. Mr. Uldriks 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. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.
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