The assignment for the paper is to provide a written summary describing why a selected medical device is safe and effective.
it should have 4 pages excluding references and cover page, AMA format only, plagiarism free
The paper should cover the following areas:
- Introduction
- Description of device and indication
- Safety summary: “Why does FDA consider this device to be safe? What measurement was used and why is it clinically meaningful?”
- Effectiveness/efficacy summary: “Why does FDA consider this device to be effective? What measurement(s) was/were used and why is it clinically meaningful?
- Summary of peer-review publications/evidence. Do subsequent published reports replicate the data in the SSED? What new information was learned?
- Conclusion
- References