Medical Device Recalls

Overview:

Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing.

Effectively managing recalls reduces regulatory risk and allows problem recovery to begin more quickly. The stakes are high and growing even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety. A part of the safety equation is looking at recalls. This seminar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk in the recall area.

Why you should Attend: Understanding FDA's processes and how they view recall actions provides companies with invaluable information for conducting and managing effective recalls. When recalls are necessary but such action is not taken or not handled properly by a company, FDA treats this seriously by carefully evaluating the potential health risk involved. This can lead to an Agency requested or mandatory recall and possibly enforcement action including device seizure, injunction, and consent decree.

Additionally, effective recalls will help reduce both negative perception of your devices and financial pressures associated with removing devices from the market or correcting them. They will also facilitate more rapid recovery from the problems that led to the recall. Here is your chance to better understand how FDA thinks and operates and what their key areas of focus and priority are from a former Compliance insider.

Areas Covered in the Session:

• What is a Recall?
• How to determine if you have a Medical Device Recall
• What can FDA do when a firm is reluctant to conduct a recall?
• Things to Consider When Recalling Your Medical Device
• Who can initiate a Medical Device Recall?
• Where and What Should Be Reported?
• Reports of Correction and Removal
• FDA Role and Expectations
• Company Responsibilities for a Recall
• FDA's Enforcement Policy on recalls
• Adverse Consequences or Health Risk Evaluations
• Safety Alerts
• Recall Strategy and Communications
• Follow-up Responsibilities (FDA and Company)
• Quality System Requirements
• Recall Classification
• Recall Status Reports
• Recall Termination

• Clinical Trial Physicians and Professionals
• Managers to Senior Directors in Reg. Affairs, QA, Clinical Research, and Data Monitoring
• Institutional Review Boards
• Small business owners