O
Oscar Wang
Hi, folks:
Our product is ultrasound Doppler diagnostic system and we are going to file a 510(K) to FDA. We looked several web training seminars and read a lot of guidance documents. Currently I am confused about the contents of this 510(k).
On one hand, the guidance document "Format for Traditional and Abbreviated 510k" illustrates the recommended documents structure as below:
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
While on the other hand, the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" suggests that the abbreviated 510(k) content should follow the guidance's structure as below:
MDUFMA Cover Sheet
CDRH Premarket Review Cover Sheet
510(k) Cover Letter
Indications for Use Statement
510(k) Summary or Statement
Truthful and Accuracy Statement
Financial Certification or Disclosure
Declarations of Conformity and Summary Reports
Standards Form FDA-3654
Clinical Trials Form FDA-3674
Executive Summary
Reason for Submission
Submission Type (Track 1 or 3)
1.3 Indications for Use:
1.4 General Device Description:
1.5 Predicate Device Comparison:
1.6 Acoustic Output Reporting:
1.7 General Clinical Safety & Effectiveness:
1.8 Labeling:
2 Track 1 Specific Information
3 Track 3 Specific Information
My question is that which document structure should I follow? Can you guys give me a clue?
Our product is ultrasound Doppler diagnostic system and we are going to file a 510(K) to FDA. We looked several web training seminars and read a lot of guidance documents. Currently I am confused about the contents of this 510(k).
On one hand, the guidance document "Format for Traditional and Abbreviated 510k" illustrates the recommended documents structure as below:
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
While on the other hand, the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" suggests that the abbreviated 510(k) content should follow the guidance's structure as below:
MDUFMA Cover Sheet
CDRH Premarket Review Cover Sheet
510(k) Cover Letter
Indications for Use Statement
510(k) Summary or Statement
Truthful and Accuracy Statement
Financial Certification or Disclosure
Declarations of Conformity and Summary Reports
Standards Form FDA-3654
Clinical Trials Form FDA-3674
Executive Summary
Reason for Submission
Submission Type (Track 1 or 3)
1.3 Indications for Use:
1.4 General Device Description:
1.5 Predicate Device Comparison:
1.6 Acoustic Output Reporting:
1.7 General Clinical Safety & Effectiveness:
1.8 Labeling:
2 Track 1 Specific Information
3 Track 3 Specific Information
My question is that which document structure should I follow? Can you guys give me a clue?