As a regulatory science student, I need to submit an application for a medical device with regulation number 872.3275 and product code EMA.
I am only responsible for the four sections listed below, and I need to create the following four documents based on the information provided above and according to the official template (maybe you can find the standard template of the cover sheet on the FDA website)
MPTX 513 510(k) Project Deliverables
Your Traditional 510(k) document format (MS Word or Adobe pdf) should follow the example presented in class…..with a TOC and Screening Checklist, followed by the 21 sections.
Table of Contents
510(k) Elements (screening checklist)
1. Medical Device User Fee Cover Sheet (form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet (form FDA 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement
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