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U.S. Department of Health and Human Services

Medical Devices

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Guidance for Third Parties and FDA Staff - Third Party Review of Premarket Notifications: Appendix 1: 510(k) Decision-making Documentation

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REVISED:3/14/95

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION-MAKING DOCUMENTATION

K____________________

Reviewer:__________________________________________________________________

Division/Branch:___________________________________________________________

Device Name:_______________________________________________________________

Product To Which Compared (510(K) Number If Known):________________________

  YES NO  
1. Is Product A Device     If NO = Stop
2. Is Device Subject To 510(k)?     If NO = Stop
3. Same Indication Statement?     If YES = Go To 5
4. Do Differences Alter The Effect Or Raise New
     Issues of Safety Or Effectiveness?
    If YES = Stop NE
5. Same Technological Characteristics?     If YES = Go To 7
6. Could The New Characteristics Affect Safety Or
     Effectiveness?
    If YES = Go To 8
7. Descriptive Characteristics Precise Enough?     If NO = Go To 10
If YES = Stop SE
8. New Types Of Safety Or Effectiveness Questions?     If YES = Stop NE
9. Accepted Scientific Methods Exist?     If NO = Stop NE
10. Performance Data Available?     If NO = Request Data
11. Data Demonstrate Equivalence?     Final Decision:

Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and 11, and every "no" response requires an explanation.

 

1. Intended Use:

 


2. Device Description: Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if necessary) to support the statement. Is the device life-supporting or life sustaining? Is the device implanted (short-term or long-term)? Does the device design use software? Is the device sterile? Is the device for single use? Is the device over-the-counter or prescription use? Does the device contain drug or biological product as a component? Is this device a kit? Provide a summary about the devices design, materials, physical properties and toxicology profile if important.

See Review Memorandum

EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED

1. Explain why not a device:

2. Explain why not subject to 510(k):

3. How does the new indication differ from the predicate device's indication:

4. Explain why there is or is not a new effect or safety or effectiveness issue:

5. Describe the new technological characteristics:

6. Explain how new characteristics could or could not affect safety or effectiveness:

7. Explain how descriptive characteristics are not precise enough:

8. Explain new types of safety or effectiveness questions raised or why the questions are not new:

9. Explain why existing scientific methods can not be used:

10. Explain what performance data is needed:

11. Explain how the performance data demonstrates that the device is or is not substantially equivalent:


ATTACH ADDITIONAL SUPPORTING INFORMATION

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