BEGIN:VCALENDAR VERSION:2.0 PRODID:-//ChamberMaster//Event Calendar 2.0//EN METHOD:PUBLISH X-PUBLISHED-TTL:P1H REFRESH-INTERVAL:P1H CALSCALE:GREGORIAN BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU DTSTART:20070101T000000 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:Eastern Daylight Time END:DAYLIGHT BEGIN:STANDARD RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU DTSTART:20070101T000000 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:Eastern Standard Time END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20261118T140000 DTEND;TZID=America/New_York:20261118T150000 X-MICROSOFT-CDO-ALLDAYEVENT:FALSE SUMMARY:From FDA Questions to 510(k) Clearance: Chemical Characterization Lessons DESCRIPTION:𝗖𝗹𝗶𝗰𝗸 𝗔𝘁𝘁𝗲𝗻𝗱 𝘁𝗼 𝘀𝗮𝘃𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝗮𝗻𝗱 𝘀𝘁𝗮𝘆 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝗼𝗻 𝗲𝘃𝗲𝗻𝘁 𝗱𝗲𝘁𝗮𝗶𝗹𝘀. \nWhen 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. \nJoin 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. \nThe 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. \nAttendees 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 \nRather 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. X-ALT-DESC;FMTTYPE=text/html:


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: \;

&bull\; Responding to FDA chemistry and biocompatibility questions late in the review cycle \;

&bull\; Evaluating extractables and leachables data in the context of regulatory expectations \;

&bull\; Building defensible toxicological risk assessments and scientific rationales \;

&bull\; Determining when additional testing is necessary and when existing data can support the submission \;

&bull\; 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.

LOCATION: UID:e.1244.1678947 SEQUENCE:3 DTSTAMP:20261029T222743Z URL:https://massmedic.growthzoneapp.com/events/Details/from-fda-questions-to-510-k-clearance-chemical-characterization-lessons-1979639?sourceTypeId=Hub END:VEVENT END:VCALENDAR