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DTSTAMP:20260531T001149Z
SUMMARY:Laboratory-Developed Tests - Medical devices 2017
DESCRIPTION:Overview:This presentation will review the legal definitio
 n of medical device, and how it is applied by FDA to in vitro diagnost
 ic tests. It will review the history of FDA interest in LDTs, and will
  describe the current situation with respect to Laboratory-developed t
 ests.\nWhy should you Attend:This 1 hour session will explore the reas
 ons FDA has for claiming such jurisdiction, and the objections to FDAs
 ' position articulated by the clinical laboratory community, and other
 s.\nAreas Covered in the Session:\"Enforcement Discretion\" and how it
  has been applied to LDT regulationExtent of CLIA '88 authority over L
 DT performanceRole of US Congress in answering the question of FDA aut
 horityInternational (EU) approach to LDTs\nWho Will Benefit:QA Special
 istComplaint CoordinatorRegulatory SpecialistQA ManagerQA TrainerAll a
 bove in Medical Device companies\nSpeaker Profile:Anna Longwell is cur
 rently principal attorney of the Palo Alto Law firm, Longwell and Asso
 ciates, which specializes in Food and Drug law. The firm has expertise
  in US FDA expectations, regulation and law, affecting the development
  and ultimate marketing of new medical products, drugs, devices and bi
 ologics. They have served the regulatory needs of large (>$2 billion/y
 ear) divisions of Fortune 500 companies, and small (4 person) biotech 
 start-ups.\nContact Detail:Compliance4All DBA NetZealous,Phone: +1-800
 -447-9407Email: support@compliance4All.com\n\nFor more information vis
 it https://medtechiq.ning.com/events/laboratory-developed-tests-medica
 l-devices-2017
DTSTART;TZID=America/New_York:20170810T100000
DTEND;TZID=America/New_York:20170810T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1419LIVE?channel=medtechiq_Aug_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501419
 LIVE?channel=medtechiq_Aug_2017_SEO
CONTACT:Event Manager
ORGANIZER:Adam Fleming
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562014627?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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