Medical Devices and Radiation-Emitting Products: FDA Requirements
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As an experienced FDA medical device investigator, at one time or another many firms have failed to incorporate the requirements of 21 CFR 1002 and 21 CFR 1040 when designing and planning to file premarket clearance documents with FDA.
Why should you Attend: Since 2004 until 2014, one of my responsibilities as an FDA investigator was to oversee the Electro-Optics Program for Southeast Region, As the Electro-Optics Specialist I inspected many medical device firms that incorporated a small laser as an aiming or positioning mechanism or applying a UV lamp to sterilize the contact surface of a medical apparatus.
There are specific requirements under FDA regulations governing these devices that many device manufacturers have failed to take into consideration. Filing the 510(k) for premarket clearance and performing biocompatibility testing, process validations, etc. come naturally as part of the natural design approval process; however the filing and reports required for radiation emitting devices are many times forgotten.
This webinar will assist the viewer with the requirements under FDA regulations to ensure you medical device is compliant with all FDA regulations and reporting.
Sufficient time will be provided for Q&A.
Areas Covered in the Session:
Who Will Benefit:
- What is a Radiation Emitting Device
- What is eSubmitter
- How to Annual Reports
- When to report to FDA
- How to report to FDA
- What can happen when you fail to report.
- All Medical Device manufacturers who have laser, x-ray or UV components as part of their medical device design 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.