Medical Device Recall - FDA Authority, Policy and Best Practices to Avoid / Manage
Casper E. Uldriks, Ex- FDA Expert & Former Associate Center Director of CDRH
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FDA’s recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The recall management knowledge you gain will sharpen how you determine the health and legal risks associated with your recall and what you can do to avoid future recalls. You will understand the critical performance targets to accomplish an effective recall and learn how missteps in the recall process become counterproductive and expensive. You will take away practical knowledge on how to work with FDA staff during a recall and how you can prepare for inspectional follow up or an enforcement action. You will learn that your approach to an enforcement action plays a major role in mitigating the firm’s business consequences due to a recall. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the likelihood or significance of a recall with proper planning.
Learn practical tips from your course instructor Mr. Casper (Cap) Uldriks who brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations.
- Understand FDA’s recall authority and policy
- Learn the mandatory requirements for device recalls
- Learn how to interact with FDA
- See how to develop health risk determinations
- Learn critical recall strategy components
- Identify options for FDA enforcement action
Who will Benefit:
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling.
- Quality & Regulatory Professionals
- Manufacturing & Design Engineers
- Marketing Product Managers
- Complaint handling personnel
- Clinical affairs
- Product and development
- Site managers, and consultants
- Contract manufacturing organization
- Contract research organization
- Senior and executive management
- Contractors and subcontractors
|Day One: 8:00 AM - 4:30 PM
||Day Two: 8:30 AM - 4:30 PM
Day 1 / Morning
FDA’s Regulatory Authority
- “Correction and Removal”
- Part 806
- 21 U.S.C. 360 h (e)
- Part 810
- Violation of the law
- Risk to Health
Day 1 / afternoon
Recalls and risk to health
- Health Hazard Evaluation
- FDA’s internal evaluation
- Vulnerable subpopulations
- Industry HHE equivalent
- Recall risk based classification
- Class I
- Class II
- Class III
- Device classification (class)
- Confusion with a recall “class”
- Statutory basis
- Differences in purpose
- Device mandatory reporting regulations
- Medical Device Reports – Part 803
- Corrections and Removals – Part 806
- Medical Device Tracking – Part 821
Day 2 / Morning
Understanding FDA’s approach to recalls
- Recall programs
- Understanding FDA’s program and implementation
- FDA’s Regulatory Procedures Manual – Chapter 7
- FDA’s Investigations Operation Manual – Chapter 7
- Preparation for FDA oversight
- Recall notification to FDA’s District Office
- Recall notification to the public
- Root cause identification
- Correction and Prevent Action (CAPA)
- FDA inspectional follow up
- Recall Exemptions
- Product Recovery
Day 2 / afternoon
- Recall expansion or termination
- Total product life cycle
- FDA premarket guidance
- FDA administrative and legal remedies
Meet Your Instructor
||Casper (Cap) Uldriks
An ex- FDA expert and former Associate Center Director of CDRH
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA’s investigators on the FDA’s legal authority and CDRH’s regulatory requirements and procedures. He continues to teach the FDA’s employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.
Cap also served in the FDA’s Office of Legislative Affairs for 5 years as the FDA’s congressional liaison for its medical device program. As a federal “Legislative Fellow” he worked for one year in a congressional subcommittee for the Energy and Commerce Committee where he drafted proposed FDA legislation for the regulation of human tissue. He managed and wrote testimony for the Commissioner for several congressional oversight hearings concerning FDA’s device program.
Cap now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law) in Washington, D.C. He counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.
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