Fundamentals of Medical Devices
Earn contact hours upon successful completion!Course content includes
Organization of Devices
- Classifications according to the Food, Drug, and Cosmetic Act
- What are general controls and special controls?
- Categories according to Interagency agreement between FDA and Health Care Finance Administration
- Significant Risk vs. Non-Significant Risk
IRB Review of Devices
Exemptions
- 510K
Special Circumstances
- Treatment IDE’s, Compassionate Use
- Humanitarian Use Devices (HDU)
- Humanitarian Device Exemptions (HDE)
Combination Products
- Is it a device, a drug, or a biologic?
- Does 21CFR312 or 21CFR812 apply?
Program Schedule and Location
Time: 9:30am - 11:30amPlace: 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
Dates: April 23, 2010 (Friday)
October 29, 2010 (Friday)
Instructor
Michael Belotto, MPH, CCRA, CCRCCost
$250 per person
Contact Hours
This CE activity was approved by the New York State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation, and is assigned approval code 6S8NVB-PRV-06250. Upon successful completion of this program, each participant will be awarded 2.0 contact hours.------------------------------------------------------------------------------------
Michael Belotto, MPH, CCRA, CCRC - Director, BRANY Institute of Research Education
Michael Belotto is the Director of the BRANY Institute of Research Education. He also serves as a research compliance expert responsible for auditing sites to ensure investigators and investigator staff compliance with ethical and clinical guidelines and FDA regulations. He serves on the BRANY Institutional Review Board.
Mr. Belotto was a paramedic in the New York City Emergency Medical Service for 10 years, with 7 years of experience in Hospital Administration.
Mr. Belotto is a graduate of New York Medical College where he completed a Masters in Public Health with a concentration in Epidemiology and Biostatistics.