FDA Guidance: Medical Device Recalls

Why Should You Attend:

Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly can lead to seizure, multiple seizures or other court action by the FDA. Effective recalls will minimize both the financial and PR issues for your firm, and will enable your firm to swiftly move to the phase of starting to re-build after an issue.

This webinar will discuss FDA guidance on medical device recalls.

Areas Covered in the Webinar:

• What Is a Recall
• Who Can Initiate a Medical Device Recall?
• How to Determine If You Have A Medical Device Recall
• Where and What Should Be Reported
• Reports of Correction and Removal
• Firm’s Responsibilities for a Recall
• FDA’s Enforcement Policy
• Adverse Consequences or Risk to Health
• Safety Alerts
• Firm’s Recall Communication
• Firm’s Recall Strategy
• Firm’s Follow-up Responsibilities
• Quality System Requirements
• Things to Consider When Recalling Your Medical Device
• Recall Status Reports
• FDA Expectations
• FDA’s Role
• Recall Classification
• What Can FDA Do When A Firm is Reluctant to Conduct A Recall?
• Recall Termination

Who Will Benefit:

• Regulatory Affairs Personnel
• Quality Assurance Managers
• Clinical Investigators
• Biostatisticians
• Institutional Review Boards
• Data Monitors
• Clinical Trial Physician / Doctor
• Data Management Professionals
• Data Monitoring Committees

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.

Topic Background:

Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the FDA. A recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

A recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA. A request by the FDA that a firm recall a device is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the device that is to be recalled.

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