510 k Summary or Statement

510 k Summary or Statement

 

 

510 k Summary or Statement is part of the 510 k file of a medical device which requires the Pre market notification from the FDA for the marketing authorization in the US market. 510 k Summary contains the summary of information on the characteristics of the subject device on which the Substantial Equivalence is claimed. 510 k statement is the declaration of the manufacturer of the medical device that they will provide the information supporting the safety and effectiveness approved by the FDA to Any person within 30 days on the written request.

 

 

The manufacturer has to make the choice between the 510 k summary or statement should be made before the 510 k is submitted. Once the Substantial equivalence is determined, they can not change the choice of 510 k Statement or Summary. The content required to be included in a 510 k Summary is as per 21 CFR 807.92 and 510 k Statement is as per 21 CFR 807.93. Once 510 k file is approved by the FDA the 510 k Summary or the 510 k Statement will publicly available in the FDA website.

 

 

What is the information that should not be included in the 510 k Summary as per FDA regulation?