The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy until the late 1980's when companies began incorporating primitive software programs in medical devices. Software can be a device by itself (i.e., stand-alone) or it can be incorporated into another device as a component, part or accessory. Under the current policy, FDA distinguishes between stand-alone software and software that is a component, part or accessory to a device.
Why should you Attend: To gain a fundamental understanding of FDA regulation of medical device software.
Areas Covered in the Session:
- Definition of medical device software
- FDA's medical device software regulatory scheme
- Software validation
- Level of concern
Who Will Benefit:
- Compliance Manager
- Validation Manager
- Regulatory Manager
- QC Managers
- QA Managers
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Medical_Device_Software
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Not sure if you want to exhibit at or attend the Webinar on FDA Regulation of Medical Device Software? See the panels below to get the information you need to make an informed decision.
|Conference/Event Dates:||06/23/2016 - 06/23/2016|
|Conference/Event Hours:||60 Minutes|
|Other Industries:||Manufacturing, Medical|
|Cost to Attend:||One Dial-in One Attendee Price: US$150.00|
|Number of Exhibitors:||1|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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