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Private Labeling of Medical Devices in the U S

In this on-demand webinar, recorded live on July 23, 2025, Sarah Lacey Robbins, Senior Quality Manager and Auditor at Rook Quality Systems, provided an overview of private labeling in medical devices, including definitions, types, and regulatory considerations. She explained that private label medical devices are manufactured by an original equipment manufacturer (OEM) but sold under another company’s brand. The session covered key regulatory definitions, types of private label arrangements (white vs. black label), and FDA requirements, including establishment registration, device listing, labeling, and Unique Device Identification (UDI). Sarah Lacey emphasized the importance of robust supplier quality agreements (SQAs) to clearly define roles and responsibilities between OEMs and private labelers, particularly around labeling ownership, complaint handling, and regulatory compliance. She also outlined the strategic advantages of private labeling, such as faster market entry and brand ownership, and concluded with best practices. The session highlighted the complexity of private labeling and the need for clear agreements and regulatory diligence. On-demand Chapters: Chapters: 00:00 – Introduction of the Presenter, Sarah Lacey Robbins, Rook QS 01:49 – Session Agenda 02:18 – Intro - Private Label Medical Devices 07:59 – Establishment Registration & Device Listing 11:28 – Labeling Requirements 17:51 – Relationships and Responsibilities 22:44 – Advantages of Using Private Labels 24:25 – Best Practices 26:33 – Questions