Private Labeling of Medical Devices in the U.S.

Join Sarah Lacey Robbins from RookQS as she discusses Private Labeling of Medical Devices in the U.S. 

Private labeling offers a powerful pathway for companies to enter the medical device market without the heavy lift of product development or a lengthy FDA submission process. While the FDA does not specifically regulate private labeling arrangements as a distinct category, private labelers still have important regulatory, labeling, establishment registration, device listing, and quality system responsibilities to meet depending on their role. In this expert-led session, Medmarc is joined by a guest speaker from Rook Quality Systems, a leading medical device quality and regulatory consultancy, to help you understand how to successfully and compliantly private label devices for the U.S. market.

What You’ll Learn:

• What private labeling means for medical devices
• Key Definitions & Players: OEMs, Private Labelers, Distributors
• White Label vs. Private Label vs. Black Label Strategies
• FDA Labeling Requirements
• Key Regulatory & Quality Responsibilities in the Private Labeling Process
• Defining Roles & Responsibilities in Supplier Quality Agreements (SQA)
• Common Pitfalls & Best Practices to Ensure Compliance and Patient Safety

Webinar Resources

 

PDF Presentation

 

Webinar Summary with Chapter Hyperlinks