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U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Notification 510(k)
  7. Premarket Notification Class III Certification and Summary
  1. Premarket Notification 510(k)

Premarket Notification Class III Certification and Summary

(As Required by 21 CFR 807.94)

(To be submitted when claiming equivalence to a Class III device)
 

I certify that, in my capacity as (the position held in company) of

(company name) that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and/or effectiveness problems that have been reported for the (device name). I further certify that I am aware of the types of problems to which the (device name) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety and/or effectiveness problems about the (device name) is complete and accurate.
 

(Attach the summary of problem data, bibliography or other citations upon which the summary is based.)


 

___________________________

(Signature of Certifier)
 

___________________________

(Typed Name)
 

____________________________

(Date)

____________________________

*(Premarket Notification [510(k)] Number)

 

*For a new submission, leave the 510(k) number blank.
 

Must be signed by a responsible person of the firm required to submit the premarket notification [e.g., not a consultant for the 510(k) submitter].

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