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When FDA trained me as a 3rd party 510(k) reviewer, they emphasized that the 513(g) is only their opinion at that time is not a final decision. The final decision on classification is the 510(k). For sure a 513(g) helps, but is no guarantee.
The latter is likely to be using the 513(g) process to verify that a device may be considered Exempt. After a device maker's due diligence and best effort to follow all the available classification procedures, FDA as a matter of political/legislative relations certainly would not want to issue a 513(g) "opinion" to that effect, then walk it back at some later date and penalize the device maker for mis-classification. In the case of a 513(g) process pursued so as to ascertain the proper classification of an Exempt device, there would be no 510(k) process to provide a superseding or final determination. The 513(g) action would have to be definitive assuming provision by the applicant of sufficiently complete and correct information.
513(g) is FDA's implementation of the section of the FD&C Act that states "(...) the Secretary shall provide such person a written statement of the classification (if any) of such device (...)". I don't know that the 513(g) process has been tested in court, but I'd guess that a legal defense or counter-action that a device maker had constructively relied on a 513(g) response on the basis of the above law-provision would be upheld.
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