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SUMMARY:Online Webinar on A second look at 510(k) changes
DESCRIPTION:Overview: The topic is 510(k) changes, a topic that is sti
 ll producing more than its share of 483's and warning letters. In gene
 ral, FDA does not return filings because the change described in them 
 is not sufficiently \"significant\", and only rarely suggests that the
  traditional 510(k) should at least be scaled down to a special 510(k)
 .\nTherefore, it is up to the sponsor/manufacturer to determine whethe
 r this change will be significant or not. The decision has to be made 
 by the manufacturer, subject to review by the FDA inspector. This talk
  will provide quality and regulatory personnel the means to help to th
 e company make the right decision and document it fully, before the ch
 ange goes through.\nWhy should you Attend: Failure to file a 510(k) fo
 r a change to a product which has already been cleared under 510(k) is
  one of the more frequent complaints in 483's and in warning letters. 
 The result of this finding is the requirement to file a 510(k) for a p
 roduct that is on the market, and usually, to file a 510(k) and have t
 he change cleared before the product can be marketed with the change. 
 In general, FDA will not insist on recalling product with the change a
 lready in the market unless they decide there is a safety issue, but e
 ven so, this means disruption of the manufacturing (already producing 
 the changed product) and marketing for the product. The best approach 
 is to understand what FDA means by a \"significant change\" and docume
 nt completely the reasons why you believe the change does not warrant 
 a filing.\nAreas Covered in the Session:Background: the regulationGuid
 ance and FDA expectationsConcrete examplesAnalysis (consecutive change
 s)and checklistDocumentation\nWho Will Benefit:QA and RA specialistsQA
  and RA managers\nSpeaker Profile:Anna Longwell is currently principal
  attorney of the Palo Alto Law firm, Longwell and Associates, which sp
 ecializes in Food and Drug law. The firm has expertise in US FDA expec
 tations, regulation and law, affecting the development and ultimate ma
 rketing of new medical products, drugs, devices and biologics. They ha
 ve served the regulatory needs of large (>$2 billion/year) divisions o
 f Fortune 500 companies, and small (4 person) biotech start-ups.\nCont
 act Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: 
 support@compliance4All.comhttp://www.compliance4all.com/Event Link : 
 http://bit.ly/510k_changesLinkedIn Like usTwitter Follow usFacebook Li
 ke us\n\nFor more information visit https://medtechiq.ning.com/events/
 online-webinar-on-a-second-look-at-510-k-changes
DTSTART;TZID=America/New_York:20160628T100000
DTEND;TZID=America/New_York:20160628T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.compliance4all.com/
URL:http://www.compliance4all.com/
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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