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UID:2140535:Event:63108
DTSTAMP:20260521T232305Z
SUMMARY:Understanding the FDA ''Refuse to Accept'' guidance to avoid a
 dministrative rejection of your 510(k)
DESCRIPTION:The webinar will familiarize participants with the FDA's R
 efuse to Accept Policy for medical device 510(k)’s and help you ensu
 re that your 510(k) application is not rejected for lack of administra
 tive completeness.\nWhy Should You Attend:FDA’s efforts to be more e
 fficient are good for industry. However, if you don’t adhere closely
  to the RTA guidance, a 510(k) application may be rejected for lack of
  administrative completeness. If an application is rejected, time dela
 ys are incurred while the deficiencies are addressed. Once corrected, 
 the application may be resubmitted and a new 15 day clock begins. Thes
 e delays could be costly in getting new technology or significant enha
 ncements to existing technology cleared and onto the US market.This pr
 esentation will help attendees navigate the RTA guidance in order to a
 void rejection of 510(k) applications for administrative incompletenes
 s.\nAreas Covered in the Webinar:-Scope of the Refuse to Accept 510(k)
  guidance-Structuring 510(k) to minimize likelihood of rejection-FDA R
 eview Clock-Notification of Acceptance-What is not part of the RTA rev
 iew-Checklist Preliminary Questions-Checklist Acceptance Review-Differ
 ences in the checklists between Traditional, Abbreviated, and Special 
 510(k)\nWho Will Benefit:This webinar will provide valuable assistance
  to:-Medical device regulatory affairs-Medical device product managers
 -Documentation-Medical device quality assurance-Clinical professionals
 \nInstructor Profile:Cheryl Wagoner, has 20 years of experience in qua
 lity assurance, and regulatory affairs. She currently is the Principal
  Consultant/Owner of Wagoner Consulting LLC, where she provides consul
 ting services to medical device and pharmaceutical companies. Previous
 ly, she has held various positions in Quality, Regulatory, Clinical an
 d Compliance in the medical device and pharmaceutical industries.Chery
 l is a member of Regulatory Affairs Professionals (RAPS), Association 
 for the Advancement of Medical Instrumentation (AAMI), Medical Device 
 Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Workin
 g Group. She completed the RAPS Executive Development Program at the K
 ellogg School of Management. She also presented “Develop a Publicati
 on Strategy with KOLs during Clinical Development” at CBI’s 8th An
 nual Forum on Interactions with Thought Leaders and Key Opinion Leader
 s (KOLs) as well as served as a panelist for “Transparency Strategie
 s and Their Impact on Relationships with Thought Leaders”.\n\nFor mo
 re information visit https://medtechiq.ning.com/events/understanding-t
 he-fda-refuse-to-accept-guidance-to-avoid
DTSTART;TZID=America/New_York:20140219T100000
DTEND;TZID=America/New_York:20140219T220000
CATEGORIES:medical
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703235?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703235?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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