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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 510(k) Statement
  1. Premarket Notification 510(k)

Premarket Notification 510(k) Statement

(As Required By 21 CFR 807.93)

I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
 

______________________________

(Signature of Certifier)
 

______________________________

(Typed Name)
 

______________________________

(Date)
 

______________________________

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

 

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

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