Grapefruit USA Inc (GPFT)

[IMGGorBust]

Thanks BennyJ. Note these two items:

b. Request AI by means other than letter ("informal" AI request)
An informal request for AI refers to a request made by telephone, fax, or e-mail, and not followed-up with a letter. An informal AI request does not result in the 510(k) being placed on "hold."

b. Informal AI request
FDA generally requests AI by means other than a letter when the agency believes the additional information is relatively minor in nature (e.g., a simple change to the device's proposed labeling) and can be provided quickly. Such requests are generally made when FDA believes the submitter can address all of the information requested within a reasonable period of time that will not delay the review and the reviewer receives the 510(k) submitter's commitment to providing the AI by the agreed upon time.