What does FDA require for Medical Devices Manufacturers to Do When Filing an Adverse Event Report (MDR)
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As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.
This webinar will assist the medial device manufacturer with determining what FDA requirements must be incorporated into the procedures and the definitions of various terminology used in the regulation. The decision making process as to when a Medical Device Report (MDR) must be filed is the single most area where device firms fails to make rational or informed decisions.
Why should you Attend: Medical Device manufacturers are aware that if an end user reports an injury to them purported to be the result of a malfunction of their device, that they must report this incident with FDA.
What they fail to always take into consideration are the other incidents that also require a Medical Device Report 3500A be filed with FDA.
Some medical device firms fail to properly establish Medical Device Reporting procedures to capture all the requirements in 21 CFR 803.
Sufficient time will be provided for Q&A.
Areas Covered in the Session:
Who Will Benefit:
- What should be included in your Medical Device Reporting Procedures
- What is a Medical Device Report 3500A
- What is eSubmitter
- Definitions of Serious Injury
- When to report to FDA
- How to report to FDA
- What can happen when you fail to report.
- All Medical Device manufacturers regardless of Class of Medical Device
Leo Lagrotte Currently serves as a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years experience with the FDA and USDA.
Mr. Lagrotte's previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.
His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004.
He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.
Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients.
At FDA and USDA he received numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.