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.
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:
Who will Benefit:
This webinar will provide valuable assistance to all medical device companies/ manufacturing sites. Those that would benefit most would be:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session