Short Abstract

The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Product liability and financial risks are staggering when companies fail to properly report and take action when required.

Firms should need to voluntarily remove their regulated product that is either defective or potentially harmful by recalling that product an implement a compliant and effective Recall program. This program should include removing it from the market or correcting the problem is the most effective means for protecting the public. A properly handled recall program can minimize the risk of major FDA enforcement activities and minimize further expensive product liability risks.

To clarify medical device recalls and the role of the manufacturer in these actions Rita Hoffman, RAC, will be providing you with FDA's expectations for a company conducting a recall, discuss the regulations which apply and provide guidance for if, when, and how a firm should prepare for and conduct a device recall.

The presentation will cover the following areas:

• 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 management team
• 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

• 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