What types of certifications and statements must be included in a 510(k) submission?

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There are two such sections in the 510(k) that are templated by the FDA. These sections include:

The Truthful and Accuracy Statement ensures that all information included is truthful and accurate and that nothing has been omitted. An example statement is:

I certify that, in my capacity as (the position held in company) of (company name), I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

The Class III Summary and Certification states that if the device is Class II, simply state “this device is not a class III device.” If the device jn question is Class III but does not require a PMA, you must provide a summary of the types and causes of safety & effectiveness problems and the corresponding supporting data. An example statement is:

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.

Similarly, sponsors musts also provide a Declaration of Conformity, which is a section where you state your use of voluntary consensus standards and how closely you conformed to them, in the case of a traditional 510(k). This section is particularly important for abbreviated 510(k) submissions, as it includes descriptions on how the device complies with special controls.

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About the Author
Proxima CRO Team
Dora Huang
Intern

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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