Stunning Changes in FDA's Software Regulation

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.

Learning Objectives:

• How Software manufacturers should identify what software is no longer regulated and why.
• If a firm wants to clear its software for marketing, how to understand the qualifications and terms of participation.
• If a firm suffers a cybersecurity intrusion, you may not be required to submit a recall report. What are benefits and risks to your options.
• You need update your regulatory program to determine which mobile apps are removed from FDA’s oversight.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• Medical device manufacturers and designers
• Retail marketers of software
• Healthcare institutions – electronic healthcare records managers (EHR)

Casper Uldriks
Former Associate Center Director, CDRH

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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