Quality in 510(k) (“Quik”) Review Program Pilot – Free PDF download







A 510(k) must meet all the following criteria to be eligible:

1. The primary product code is on the pre-identified list of product codes
2. The submission was constructed with the eSubmitter template “CDRH: Non-In Vitro Diagnostic Device – 510(k)”
3. The product is not a combination product (for example, drug-device or biologic-device combination)
4. The lead Center for the device is the FDA’s Center for Devices and Radiological Health (CDRH)

Preparing the 510(k)
Use the eSubmitter template entitled “CDRH: Non-In Vitro Diagnostic Device – 510(k)”

Organize according to the layout of the template
• Final package contains PDF attachments and XML file types
– XML files are used to process the application and will not be seen by FDA reviewers
• Electronic signatures are used in the submission (for example, on the Truthful and Accurate statement), rather than physical signatures
• Structure and questions complement the smart template


Download PDF here

Continue at:  https://www.fda.gov/downloads/Training/CDRHLearn/UCM622899.pdf

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