When Do You Need a 510K?


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This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.

Course "Webinar: When Do You Need a 510K?" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

FDA is responsible for overseeing entry into the market of all medical devices. All devices, unless exempt, must go through a pre-market review for safety and efficacy. Anyone who wants to be a player in the medical device market must have a sound understanding of what is expected by FDA, and especially in the case of 510K clearance procedures he/she must know when it is or is not appropriate to submit a 510K for a medical device prior to marketing or during marketing due to changes in or to the device.

This knowledge is important to individuals involved because the penalties for a mistake range from a possible criminal prosecution of the “responsible” person(s) to a civil penalty, possibly up to $1,000,000, and/or FDA ordering a recall of the device if it is being marketed or filing a civil seizure lawsuit to have all the devices on the market seized by US Marshalls.

This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs. It will give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device. We will also discuss what to do if the decision is to not file a 510K to satisfy the FDA when it conducts its next inspection.

Areas Covered in the Seminar:

  • 510K submission.
  • Premarket Approval submission.
  • History of the 510k since it was initially created in 1976.
  • When between a PMA and 510k, submitting a 510K is appropriate?
  • PMA versus a 510K - time and cost factors.
  • Failure to submit a 510K - individual(s) responsibility, corporate responsibility, criminal prosecution and penalties.
  • Civil penalty, civil action and injunction action.
  • When not to file a 510K in Class I and Class II devices.
  • Managing FDA inspection when 510K is not files.

Who will Benefit:

This webinar will provide valuable assistance to all medical device companies/ manufacturing sites.  Those that would benefit most would be:

  • Technical Directors / VP's
  • Product Development Managers
  • Operations / Production Managers
  • Compliance Directors/Managers
  • Regulatory Affairs/ Quality
  • Marketing
Webinar Events
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Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


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