MCCRSCC Types of Device Modifications Questionnaire
I’m working on a health & medical writing question and need an explanation to help me learn.
Please answer the following question
1. List three types of device modifications that require a new 510(k) notice (6 points)
2. Briefly (in your own words) describe the modification, and (12 points)
3. Explain why each modification requires a 510(k) notice. (12 points)