FDA 510(k) Introduction
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
The FDA does not provide a 510(k) template and they do not provide much information on what needs to be included in each section of the 510(k). As a result, many people that try to complete them find the process more difficult than they expected, leading to significant delays in getting their product approved for sale. Also, the FDA 510(k) summary document provided online for public viewing is just a small fraction of a completed 510k application which often runs 50-100 pages in length. For this reason, many consultants charge an hourly rate to complete 510(k) applications, leaving you with the uncertainty of how much it will ultimately cost to obtain FDA clearance.
Our FDA 510(k) Services Include:
1) Identify a predicate device(s) or verify that the predicate device(s) used in your submission meets FDA criteria.
2) Write the "substantial equivalence" section of the 510 (k) that compares your device to the predicate device(s).
3) Determine if FDA Guidance Documents are applicable to your medical device.
4) Contact the FDA Office of Device Evaluation to determine any special requirements for their review of this product, if necessary.
5) Prepare and submit the FDA 510 (k) application to the FDA in electronic and hard copy format.
6) Write the Executive Summary section of the 510 (k).
7) Coordinate with you and the FDA reviewer, and assist with the preparation of a response if the FDA has questions or requires additional information.
8) 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.