Informational pull-down box from “FDA Consulting Services”: (hypertext) for each one

About 510(k) applications to the FDA:

Has a similar medical devices already been cleared by the FDA?

1) Find another medical device that is similar to your that has already received 510(k) clearance.  These are called “Predicate Devices”  and can be found by visiting www.fda.gov/search/databases.html and seeing the section entitled “Medical Devices”. Be sure to make a note of the predicate 510(k) Number, Regulation Number and Classification Product Code.
2) Determine whether any Standards and/or Guidance documents apply to your device using the Product Classification Code.  These are also requirements you must meet as part of the 510(k) process.
3) You must prepare and submit the 510(k) application to the FDA after predicate devices have been found.  The FDA charges a fee to review your application.
4) The FDA will review your application.  The FDA usually completes this task within 90 days.  Should you be successful, you will receive a 510(k) clearance letter from the FDA with your 510(k) number.
5) Finally, go to www.fda.gov/cdrh/reglistpage.html to register your device and company with the FDA.  You will be required to provide your 510(k) number.  If you are outside of the United States, you must appoint a US Agent at this time.
6) Once all the fees are paid and forms submitted online, you are cleared to sell your device in the USA.  Your company becomes subject to inspection for compliance with Good Manufacturing Practices at any time.