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Webinar: When Do You Need a 510K?

Date: 07-Mar-12 to 07-Mar-12
Location: Online Webinar / California City / United States
Category: Healthcare & Pharmaceuticals

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.
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.

Visitors

# Technical Directors / VP's
# Product Development Managers
# Operations / Production Managers
# Compliance Directors/Managers
# Regulatory Affairs/ Quality

Exhibitors

At ComplianceOnline, we are focused on :
Enhancing global compliance, creating a world where quality and compliance professionals, regulators,and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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