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DTSTART:19700308T020000
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DTSTAMP:20260520T224740Z
SUMMARY:Understanding Combination Products, Requests for Designation a
 nd Product Jurisdiction
DESCRIPTION:Overview:\nThis webinar will provide a detailed discussion
  of understanding the definition of a combination product, the categor
 ies of combination products, how combination products are reviewed, ho
 w to assemble a request for designation (RFD) and how to work with FDA
  when submitting applications for combination products. To do this it 
 will reference the extensive information provided by FDA's Office of C
 ombination Products. Why Should you Attend: \nYou should attend beca
 use understanding how combination products are reviewed by FDA is crit
 ical to avoiding costly and time-consuming mistakes with respect to wh
 ich part of FDA will have the primary jurisdiction for a given combina
 tion product. Understanding how FDA determines the primary jurisdictio
 n for a combination product (i.e., which Center will be the lead Cente
 r for review of the application) will allow companies to have the most
  appropriate information in the submission and know who their primary 
 contacts in FDA will be. Areas Covered in the Session:\n\nDefinition 
 of a combination product\nCategories of combination products\nHow comb
 ination products are reviewed\nHow to assemble a request for designati
 on (RFD)\nHow to work with FDA when submitting applications for combin
 ation products\n\nWho Will Benefit:\n\nRegulatory Affairs Professional
 s\nStaff with responsibility for preclinical testing of medical device
 s\nAll companies developing\nManufacturing and Marketing medical devic
 es in the US\n\nQuick Contact:\nGlobalCompliancePanel USA Phone:800-44
 7-9407Fax: 302-288-6884webinars@globalcompliancepanel.comhttp://www.gl
 obalcompliancepanel.comFor More Info Click Here\n\nFor more informatio
 n visit https://medtechiq.ning.com/events/understanding-combination-pr
 oducts-requests-for-designation-and
DTSTART;TZID=America/New_York:20140814T100000
DTEND;TZID=America/New_York:20140814T110000
CATEGORIES:webinar, pharma, medical, clinical, health
LOCATION:Online Event
WEBSITE:http://bit.ly/1ogZzNG
URL:http://bit.ly/1ogZzNG
CONTACT:18004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011725?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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