Why You Should Attend: Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance).
Also, with the proliferation of numerous applications in the Health Care, some developers are still unsure whether or not their product is a medical device. Finally, even though some applications can meet the definition of a medical device, Guidance indicates that FDA is not going to regulate them. Can you tell which is which?
Areas Covered in the Session:
Who regulates software and why
How to tell if the software you are developing is a medical device
What does “enforcement discretion” mean and how does it apply to software
What are the expectations for software that’s an integral part of a device
What about software that is offered to analyze signal from a medical device, but is not a part of the device, has a different manufacturer and seller? (e.g., sequencer raw data from manufacturer A, can be analyzed by software from either software seller B or C, and translated using different interfaces from either B or C to the local LIMS
What about software used in the manufacturing process but not sold
Who is enforcing HIPAA, Patient privacy, for device software?
And what does Part 11 have to do with my software?
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