The Advanced Medical Technology Association (AdvaMed) will host a conference call for the media to release a white paper addressing modifications to marketed medical devices cleared through FDA’s 510(k) process. The document includes a comprehensive analysis of the laws and regulations underlying the 510(k) process and includes recommendations to improve the current guidance for determining when a change to a 510(k)-cleared device requires a new premarket submission. Release of the white paper comes in advance of an FDA public meeting on the topic scheduled for Thursday, June 13.
WHO:
Janet Trunzo, Senior Executive VP, Technology & Regulatory Affairs, AdvaMed
Tamima Itani, VP, Global Regulatory Affairs and Regulatory Compliance, Boston Scientific
Danelle Miller, Global Regulatory Counsel, Roche Diagnostics
WHEN:
Wednesday, June 12, 2013, 1:00 pm EST
To receive dial-in information for the call, please RSVP to Christina Hoffman at choffman@advamed.org.
