Description: This webinar will address the regulatory and scientific considerations for allograft-based bone void filler regulated as devices under FDA's 510(k) pathway in the Center for Devices and Radiological Health (CDRH). Participants will be guided through the 510(k) pathway from product concept to marketing authorization and beyond, including when allograft-based bone void fillers would be considered a device under 510(k), what marketing claims are permissible for these devices, how to identify a predicate, and what types of testing are necessary. The webinar will also include how participants can obtain feedback related to their allograft-based bone void filler and best practices for interacting with FDA.

Educational Objectives:

• Identify when a 510(k) is needed for allograft-based bone void fillers.
• Understand how to select a predicate and the substantial equivalence decision-making.
• Describe the types of non-clinical and animal performance testing necessary to support a 510(k).
• Understand best practices when interacting with the Agency.

Target Audience: This webinar is designed for tissue bank professionals with expertise in QA/QC, regulatory, research, processing and distribution.