Description

𝗖𝗹𝗶𝗰𝗸 𝗔𝘁𝘁𝗲𝗻𝗱 𝘁𝗼 𝘀𝗮𝘃𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝗮𝗻𝗱 𝘀𝘁𝗮𝘆 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝗼𝗻 𝗲𝘃𝗲𝗻𝘁 𝗱𝗲𝘁𝗮𝗶𝗹𝘀. 

When the FDA requested additional information on the chemistry and toxicological assessment for an orthopedic Class II device late in the review process, the project team faced a familiar challenge: how to address complex regulatory questions without derailing launch timelines. 

Join David Kirshman (Orthomod), Stephen Spiegelberg (Chief Scientific Officer, Cambridge Polymer Group), Becky Bader (Director of Regulatory Services, Cambridge Polymer Group), and Hany Demian (Demian Medtech Regulatory Consulting) for a practical case study on navigating FDA requests for additional information related to chemical characterization, toxicological risk assessment, and biocompatibility justification. 

The panel will discuss how the team evaluated FDA's concerns, identified potential data gaps, determined when existing information could be leveraged effectively, and developed a scientifically defensible response strategy. Speakers will share how manufacturer knowledge, analytical chemistry expertise, toxicological assessment, and regulatory strategy were integrated to support successful 510(k) clearance. 

Attendees will gain insight into: 

• Responding to FDA chemistry and biocompatibility questions late in the review cycle 

• Evaluating extractables and leachables data in the context of regulatory expectations 

• Building defensible toxicological risk assessments and scientific rationales 

• Determining when additional testing is necessary and when existing data can support the submission 

• Coordinating effectively among manufacturers, testing laboratories, toxicologists, and regulatory consultants 

Rather than focusing on a specific product, this discussion will highlight the decision-making process, collaboration strategies, and practical lessons learned that device manufacturers can apply to their own submissions when facing challenging FDA requests.