RPA's FDA 510(k) preparation and submission services include:

 

• Identify a predicate device(s) or verify that the predicate device(s) used in your submission meets FDA criteria.
• Write the "substantial equivalence" section of the 510 (k) that compares your device to the predicate device(s).
• Determine if FDA Guidance Documents are applicable to your medical device.
• Contact the FDA Office of Device Evaluation to determine any special requirements for their review of this product, if necessary.
• Prepare and submit the FDA 510 (k) application to the FDA in electronic and hard copy format.

• Write the Executive Summary section of the 510 (k).
• Coordinate with you and the FDA reviewer, and assist with the preparation of a response if the FDA has questions or requires additional information.
• Monitor the progress of the FDA 510 (k) Pre Market Notification through the FDA review process and supply you with periodic updates as they become available.
   

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