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UID:2140535:Event:63218
DTSTAMP:20260914T024728Z
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.\n\nWhy Should You Attend:\nFDA’s efforts to be mo
 re efficient are good for industry. However, if you don’t adhere clo
 sely to the RTA guidance, a 510(k) application may be rejected for lac
 k of administrative completeness. If an application is rejected, time 
 delays are incurred while the deficiencies are addressed. Once correct
 ed, the application may be resubmitted and a new 15 day clock begins. 
 These delays could be costly in getting new technology or significant 
 enhancements to existing technology cleared and onto the US market.\nT
 his presentation will help attendees navigate the RTA guidance in orde
 r to avoid rejection of 510(k) applications for administrative incompl
 eteness.\nAreas Covered in the Webinar:\n\nScope of the Refuse to Acce
 pt 510(k) guidance\nStructuring 510(k) to minimize likelihood of rejec
 tion\nFDA Review Clock\nNotification of Acceptance\nWhat is not part o
 f the RTA review\nChecklist Preliminary Questions\nChecklist Acceptanc
 e Review\nDifferences in the checklists between Traditional, Abbreviat
 ed, and Special 510(k)\n\nWho Will Benefit:\nThis webinar will provide
  valuable assistance to:\n\nMedical device regulatory affairs\nMedical
  device product managers\nDocumentation\nMedical device quality assura
 nce\nClinical professionals\n\nInstructor Profile:\nCheryl Wagoner, h
 as 20 years of experience in quality assurance, and regulatory affairs
 . She currently is the Principal Consultant/Owner of Wagoner Consultin
 g LLC, where she provides consulting services to medical device and ph
 armaceutical companies. Previously, she has held various positions in 
 Quality, Regulatory, Clinical and Compliance in the medical device and
  pharmaceutical industries.\n\nFor more information visit https://medt
 echiq.ning.com/events/understanding-the-fda-refuse-to-accept-guidance-
 to-avoid-1
DTSTART;TZID=America/New_York:20140219T100000
DTEND;TZID=America/New_York:20140219T110000
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:ComplianceOnline
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 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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