AdvaMed releases white paper on 510(k) modifications

Association to present at FDA public meeting June 13

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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.
 

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