FDA Regulation of Medical Device Software

Overview:

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 you should 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