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.
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.
This webinar will provide valuable assistance to all medical device companies/ manufacturing sites. Those that would benefit most would be:
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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