Replies to post #47048 on Grapefruit USA Inc (GPFT)

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What was posted is correct

Agreement Meeting
The other opportunity for a meeting established by FDAMA is an Agreement Meeting, described
in §520(g)(7), which is open to any person planning to investigate the safety or effectiveness of
a class III product or any implant. Thus, unlike the Determination Meeting, the Agreement
Meeting is available to submitters of 510(k)s for eligible devices. The purpose of this meeting is
to reach agreement on the key parameters of the investigational plan (see 21 CFR 812.25),
including the clinical protocol. The meeting is to be held within 30 days of the receipt of a
request for such a meeting. Any agreement reached in this meeting is also to be written, shared
with the applicant, and made part of the administrative record. It is binding on the Agency and
may be changed only with the written agreement of the applicant or when there is a substantial
scientific issue essential to determining the safety or effectiveness of the device