The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls. With very few exceptions, device recalls by companies are voluntary.
There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.
Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years. We will take the time to interact though the day to navigate all aspect of the recall process
This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.
Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance. Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.
Areas covered by the Instructor:
Determine what actions are taken in a medical device recall
- Cite the regulatory requirements for recalls/ field actions regarding medical devices
- Reference and use medical device recall authority and guidance documents
- Identify and understand the applicable regulatory standards and guidance documents
- Identify the different recall types and classifications
- Explain what types of communications are required
- Define what effectiveness checks are
- Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
- Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
- Firms MDR reporting and FDA’s handling of MDR reports
- Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
- Minimize your risk of regulatory enforcement actions
- Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Walk-through of case examples
- Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls