Medical Device Recalls and Regulatory Enforcement
This webinar by Ms. Rita Hoffman, formerly FDA’s Branch Chief for CDRH Recalls, will cover FDA's
expectations for a company conducting a recall and discuss the regulations which apply and provide
guidance for if, when, and how a firm should prepare for and conduct a device recall.
Why Should You Attend:
When an FDA-regulated product is either defective or potentially harmful, recalling that product by
implementing a compliant and effective recall program, that includes removing it from the market or
correcting the problem, is the most effective means for protecting the public. Properly handled, a
recall program can minimize the risk of major FDA enforcement activities and minimize further
expensive product liability risks.
During this session, Ms. Rita Hoffman, formerly FDA’s Branch Chief for CDRH Recalls, will clarify
medical device recalls and the role of the manufacturer in these actions. In this training, you will be
provided with FDA's expectations for a company conducting a recall. We will also discuss the
regulations which apply and provide guidance for if, when, and how a firm should prepare for and
conduct a device recall.
What you will get:
Tools and mechanisms to assist you with understanding the recall process.
Links to pertinent FDA requirements.
Examples of medical device recalls.
Enforcement plans by FDA.
Practical advice from an experienced and respected panel.
Time for questions and answers.
What you'll learn:
What FDA means by the term Recall?
The essential elements to help firms understand the difference between a Medical Device
Recall, Market Withdrawal, Safety Alert.
How to implement an effective voluntary recall program.
Identifying the problem and cause of the recalling product.
Know the timeframes for submission of an 806 (Correction and Removal Report).
What is CDRH's Health Hazard Evaluation Process?
How to develop an plan for effectiveness checks
What to do if your firm has a Class I recall?
How to develop effective Standard Operating Procedures for recalling your product.
Developing and recognizing a crisis, when to go into crisis mode and forming your crisis
The common mistakes companies make when recalling products.
How to implement a corrective action program for a recall.
Points to include in an effective notification letter.
How to implement an effective audit program.
Who, how and when to notify the FDA of a recall situation?
What FDA can do when a firm is reluctant to conduct a recall?
What to look for during manufacturing process to help avoid a recall situation?
Effective communication with FDA District Recall Coordinators.
Steps in an effective course of action during a recall.
How to implement an effective recall strategy.
The definition of a “silent” recall.
The best ways to effectively communicate with FDA Headquarters.
Who Will Benefit:
Quality & Regulatory Professionals
Rita Hoffman, RAC. Managing Partner RHoffman, Inc. Ms. Hoffman has more than 36 years of FDA
experience across the device, drug and veterinary industries. She has an intimate understanding of
FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an
FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance
deficiencies, performs compliance and new product audits, provides insight and guidance on recall
strategies to the medical device industry, and advises on jurisdiction determinations for combination
Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for
Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all
medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation
and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product
designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business
Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-
chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was
presented with the Special Recognition Award by RAPS.