Importance of documenting changes to device design

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Reference no: EM133317728

Assignment:

Readings bring together a number of topics we have studied throughout this course. In the Recalls vs. Enhancements guidance, it makes clear the importance of documenting changes to your device design and submitting new applications, when required. In the MDR guidance, there is a discussion about ensuring your device design is well-considered and does not lead to user error. And in the two analyses of 2017 enforcement actions, we see some of the most common causes for FDA to issue warning letters -- from poor documentation to advertising and promotion violations.

As we approach the culmination of this course and begin to prepare for our final, we need to start to make the connections from the various pieces we have covered to understand how they contribute to the regulation of medical devices as a whole. By the end of the day on Friday (12/9), please choose one topic from anything covered in readings and relate the material to something we have discussed or read in previous weeks. One primary post per student is sufficient, secondary posts are not necessary for this final discussion board.

Reference no: EM133317728

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