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DTSTAMP:20260520T110341Z
SUMMARY:Webinar on A second look at 510(k) changes
DESCRIPTION:Overview: The topic is 510(k) changes, a topic that is st
 ill producing more than its share of 483's and warning letters. In gen
 eral, FDA does not return filings because the change described in them
  is not sufficiently \"significant\", and only rarely suggests that th
 e traditional 510(k) should at least be scaled down to a special 510(k
 ).\nTherefore, it is up to the sponsor/manufacturer to determine wheth
 er this change will be significant or not. The decision has to be made
  by the manufacturer, subject to review by the FDA inspector. This tal
 k will provide quality and regulatory personnel the means to help to t
 he company make the right decision and document it fully, before the c
 hange goes through.Why should you Attend: \nFailure to file a 510(k) 
 for 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
  product that is on the market, and usually, to file a 510(k) and have
  the change cleared before the product can be marketed with the change
 . In general, FDA will not insist on recalling product with the change
  already in the market unless they decide there is a safety issue, but
  even so, this means disruption of the manufacturing (already producin
 g the changed product) and marketing for the product. The best approac
 h is to understand what FDA means by a \"significant change\" and docu
 ment completely the reasons why you believe the change does not warran
 t a filing. Areas Covered in the Session:\n\nBackground: the regulati
 on\nGuidance and FDA expectations\nConcrete examples\nAnalysis (consec
 utive changes)and checklist\nDocumentation\n\nWho Will Benefit:\n\nQA 
 and RA specialists\nQA and RA managers\n\nSpeaker Profile:\n\nAnna Lon
 gwell is currently principal attorney of the Palo Alto Law firm, Long
 well and Associates, which specializes in Food and Drug law. The firm 
 has expertise in US FDA expectations, regulation and law, affecting th
 e development and ultimate marketing of new medical products, drugs, d
 evices and biologics. They have served the regulatory needs of large (
 >$2 billion/year) divisions of Fortune 500 companies, and small (4 per
 son) biotech start-ups. Prior to establishing the firm, Ms. Longwell w
 as VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billi
 on/annum unit of BD engaged in global manufacture and sale of medical 
 devices, consumer products and OTC drugs. In that context, she partici
 pated as regulatory expert in many pre-acquisition due diligence teams
 . \nContact Detail:\nNetZealous - Compliance4All,161 Mission Falls La
 ne, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: s
 upport@compliance4All.comhttp://www.compliance4all.com/Event Link : h
 ttp://bit.ly/1haBf0O\n\n\n\nFor more information visit https://medtech
 iq.ning.com/events/webinar-on-a-second-look-at-510-k-changes
DTSTART;TZID=America/New_York:20151015T100000
DTEND;TZID=America/New_York:20151015T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1haBf0O
URL:http://bit.ly/1haBf0O
CONTACT:18004479407
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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