Webinar: When Do You Need a 510K?

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.

• 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.

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

Instructor Profile:

Charles R. (Bob) McConachie

Charles R. (Bob) McConachie, is a Dallas, Tx attorney. He has practiced food and drug law beginning in 1970 at the Department of Justice where he litigated FDA enforcement and regulatory law cases in federal courts. From 1975 to 1979 he served as Chief of the Consumer Affairs Section, now the Consumer Protection Division of the Civil Division at DOJ. Among other cases he personally argued the case in which the FDA’s decision to remove Red Dye No. 2 from the market by the end of the day was upheld by the DC Circuit.

In private practice since 1980 Mr. McConachie has advised food and drug clients on many aspects of food and drug law including compliance with FDA law and regulation of drugs, devices, food and food supplements. From 1982 until 2006 he served as an adjunct professor at SMU School of Law teaching the Food and Drug Law course. As a speaker Mr. McConachie has made presentations at FDLI and State Bar of Texas educational conferences on numerous occasions. Mr McConachie received the BBA degree from The University of Texas and the JD degree from St. Mary’s University of San Antonio.