Stunning Changes in FDA's Software Regulation

Stunning Changes in FDA's Software Regulation
Product Code: : MDAQ-9289
Speaker : Casper Uldriks
Date : 2nd July 2019
Time : 10:00 AM PST | 01:00 PM EST
Duration : 60Min

Topic Background:

FDA has struggled with regulating software for about 25 years. When the Federal Food, Drug, and Cosmetic Act (FDCA) was amended in 1976 to regulate devices, the software was not considered. It did not exist as a regulatory issue. With the advent of increasingly sophisticated software, the increasing use of software and the dramatic increase of mobile apps, FDA, the industry, and Congress became aware that the FDA was in over its head. Congress has redefined the scope of the FDA's jurisdiction over software. In a rare case in history, the FDA is scaling back its regulatory boundaries.


Congress removed some software products out of FDA's jurisdiction. On balance, the benefit did not outweigh the cost of the regulatory burden. That is a stunning "least burdensome approach." FDA is planning to give additional regulatory relief to its regulation of software. Now the question is whether or not you are in a "relief zone." Those boundaries are grey. We are looking at no regulation of some software, easier regulation for some software premarket (510(k)) submissions and an accelerated assessment of products deemed part of a "Digital Health" initiative, which has a startling change for premarket access. Firms can clear their own Software 510(k).

Why Should You Attend:

FDA's regulation of software provides major relief to firms involved with software, especially low-risk software. Firms should be re-evaluated the software they market to determine if the regulatory relief applies to the software they market. Are you developing your risk assessment? Criteria so you can justify saying, (1) "My software is not regulated" (2) "Does my firm meet the criteria to clear its own software 510(k)'s?" or (3) "My software qualifies as digital health software." These are questions that require work now so that you reap the rewards going forward.

Objectives of the Presentation: 

  • Identify software that is no longer regulated by the FDA
  • Identify FDA guidance documents that will be revised or withdrawn
  • Identify mobile apps exempt from FDA regulation
  • Identify premarket shortcuts for software 510(k) clearance
  • Identify recall reporting options for cybersecurity problems
  • Highlight the FDA's Digital Health initiative

Areas Covered in the Session:

  • 21st-Century Cures Act impact
  • Software no longer under FDA jurisdiction
  • Changes in premarket requirements
  • Voluntary controls short cuts
  • Post market reporting optionsDigital Health Initiative - FDA clearance not required

Who will Benefit:

  • Regulatory Affairs Directors
  • Software Designers / Specification Developers
  • Production Managers
  • Quality Assurance Directors
  • In-house Legal Counsel
  • Importers of software-based devices
  • Software Engineers
  • IT Managers
  • Third Party Software Services
  • Regulatory Affairs Managers
  • Healthcare Institution Risk Managers
  • Complaint Investigation Teams

Speaker Profile:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.

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