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UID:2140535:Event:66289
DTSTAMP:20260521T160503Z
SUMMARY:Bullet Proof 510(k) – Latest FDA Changes to the Process
DESCRIPTION:This 3 hour Webinar is a primer and overview to the premar
 ket notification process, i.e., a 510(k). A 510(k) is a premarket subm
 ission made to FDA to demonstrate that your device to be marketed is a
 t least as safe and effective, that is, substantially equivalent, to a
  legally marketed device that is not subject to PMA.\n\nOverview: \nT
 here are three types of Premarket Notification 510(k)s that may be sub
 mitted to FDA: Traditional, Special, and Abbreviated. The Special and 
 Abbreviated 510(k) methods were developed under the \"New 510(k) Parad
 igm\" to help streamline the 510(k) review process.\nProduct modificat
 ions that could significantly affect safety and effectiveness are subj
 ect to 510(k) submission requirements under 21 CFR 807 as well as desi
 gn control requirements under the Quality System (QS) regulation. Unde
 r the QS regulation, all Class II and III devices and certain Class I 
 devices are required to be designed in conformance to 21 CFR 820.30 De
 sign Controls. FDA provides guidance and this course will address key 
 resources when making critical decisions.Objectives:\n\nKnow the diffe
 rences between the Traditional, Special and Abbreviated submissions\nU
 nderstand Substantial Equivalence and how it is applied\nWho is requir
 ed to submit the application to FDA\nWhere to submit the 510(k) and wh
 at to expect with the review and approval process\nWhen it is and is n
 ot required if you are a device company\nExemptions to the submission 
 process and special considerations\nHow to locate a \"predicate\" devi
 ce and go through the content and format of the 510(k)\nUnderstand the
  De Novo process and the expectations for possibly marketing a low ris
 k device\nUnderstand the potential impact of FDA's proposed changes to
  the 510(k) process and why manufacturers need to pay attention \n\nC
 ompliance4AllAdam FleamingPhone: +1-800-447-9407 support@compliance4al
 l.comwww.compliance4all.comEvent Link :http://www.compliance4all.com/c
 ontrol/w_product/~product_id=500394LIVE/\n\nFor more information visit
  https://medtechiq.ning.com/events/bullet-proof-510-k-latest-fda-chang
 es-to-the-process
DTSTART;TZID=America/New_York:20150901T100000
DTEND;TZID=America/New_York:20150901T130000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 0394LIVE/
URL:http://www.compliance4all.com/control/w_product/~product_id=500394
 LIVE/
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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