Biomedical Engineering Reference
In-Depth Information
The 510(k) submission is now wholly electronic, but you will need to produce a submission
document. It is a good idea to build this in electronic form, then print it and put it in a ring
binder. This simple process ensures two things:
1.
You do not leave any section blank.
2.
You use U.S. letter size paper: not A4!
The document has standard sections that you can download from the FDA website. You
should download the Format for Traditional and Abbreviated 510(k) submissions guidance
document ( FDA, 2005 ) and have this close at hand. Furthermore, the FDA website contains
very detailed instructions on their website.
Your submission document must contain all 21 sections ( Table 14.3 ). If you have no entry in
a section, do not remove it. Put in a statement that states that this section is not relevant and
give a reason. For example, “This device does not contain software.”
Most sections have a specific format that the FDA is looking for. Hence there are two pieces
of advice:
a.
Use the FDA guidance sheets as they tell you exactly what the FDA examiners want
and in what format they want it.
Table 14.3: 510(k) Submission Sections
1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet
3. 510(k) Cover Letter
4. Indications for Use Statement
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformity and Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing - Bench
19. Performance Testing - Animal
20. Performance Testing - Clinical
21. Other
 
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