Our FDA 510(k) submission and preparation services include:

• Verification that the predicate device(s) you wish to use in your submission meet the criteria.
• Research and provide the required data from FDA Guidance Documents during our review process
• Contact the FDA Office of Device Evaluation to determine any requirements for their review of this product
• Assist in the preparation of the FDA 510(k) submission
• Submit the FDA 510(k) application (or amendment) to the FDA in a consistent manner for all submissions
• Coordinate and work with the client and FDA review team. Often additional questions or more substantiated data are requested by the FDA
• Assist with the preparation of a response if the FDA has questions or requires additional information
• Act as the official correspondent on the application and remain accessible to the FDA for any future discussions regarding the 510k submission
• Monitor the progress of the FDA 510(k) through the FDA review process and supply you with periodic updates as they become available
• Prepare the Safety and Efficacy summary
• Provide phone consultation during the FDA510(k) application and 510 k approval process

• info@kobridgeconsulting.com