RAPS - This course has been pre-approved by RAPS as eligible for up to 1 credits towards a participant's RAC recertification upon full completion.


The difference between a medical device recall, under FDA regulation, and a product enhancement confuses most regulatory managers.  In both cases you are making a change in either the labeling or the device itself or both.  The type of change you are making makes a big difference. Recalls have extensive information requirements and interactive oversight by the FDA. The product recall coordinator in the FDA field office and a product manager at the Center for Devices and Radiological Health (CDRH) become involved in your decision-making process. Device enhancements remain under the control of the firm without the required interaction with the FDA. That alone makes a big difference. So, is there a rule of thumb? Are you fixing a problem or making a “new and improved” device? That makes a big difference when it comes to financial outcomes. 

The medical device industry often fumbled with what to report and what not to report as a recall to the FDA. The luxury of not reporting a recall ended with the implementation of the Safe Medical Devices Act (SMDA), which generated required Reports of Removals and Corrections submissions to the FDA (21 C.F.R. Part 806). This begs the question of whether or not to report a change you made to the device you market. A “new and improved” product is not reportable. That is a big money maker. A device recall is reportable and costs a lot of money. There is always the temptation to opt for the former.

Learning Objectives

  • Distinguish recall actions from product enhancements
  • Who decides the difference between a recall and an enhancement
  • CAPA program’s role
  • Rule of thumb guidance

Webinar Takeaway

  • Risk management
  • Design controls
  • User feedback vs. complaint
  • Consumer preferences
  • Public disclosure of the change

Who Will Benefit

  • Regulatory Affairs Managers
  • Complaint coordinators
  • Product design engineers
  • Product managers
  • Sales and Marketing

Faculty Casper E. Uldriks

Faculty Casper Uldriks

Encore Insight LLC
Suffolk University Law School
Silver Spring, Maryland, United States

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance at the Center for Devices and Radiological Health (CDRH) and as the Associate Center Director for Regulatory Guidance and Government Operations at CDRH. He developed enforcement actions for FDA and participated in the implementation of new statutory requirements, such as for FDA’s import/export program and medical device program. He also served as a public health specialist in 1993 for the House of Representatives Subcommittee on Small Business. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He is licensed to practice law in the District of Columbia and the Commonwealth of Massachusetts.  


RAPS - This course has been pre-approved by RAPS as eligible for up to 1 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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