RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:It doesn't take a full moon to bring out crazy DrCashCan't see why they would put it on hold for details that would not influence the decision.
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089738.pdf
C. Request Additional Information (AI)
FDA requests AI when the 510(k) submission lacks information necessary for the agency
to continue or complete the review and to determine whether the device is SE or NSE (21
CFR 807.87). AI requests may be issued by letter, or may be issued by telephone, fax, or
e-mail, with a follow-up letter informing the submitter that the 510(k) is being placed on
hold pending receipt of a response to all of the identified deficiencies. The hold starts on
the issue date of the detailed AI letter or the letter confirming the hold relating to AI
issues that were conveyed by telephone, fax or email.
FDA generally issues an AI request when FDA believes the additional information
needed from the submitter is not suitable for interactive review and/or cannot be provided
within a reasonable period of time (i.e., such that the review would be unduly delayed if
the submission were not placed on hold).
An AI request is an interim action that stops the review clock and marks the end of an
FDA review cycle. The review clock will resume upon the receipt of a complete response
to the AI request in the appropriate Document Control Center.
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