Replies to post #16214 on 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.

[Admiral38]

Okay, I've read the stuff and still don't know when the clock started on any of these actions. So they've got 90 days, from when? I'm sorry, but the regulation means nothing unless we know what formal action started when. Are we to assume the 90 day clock starts when tdhe FDA makes a phone call to the company or did it start the first day they received the paperwork on the device? There have been so many declarations on this board about everything that's happened, I have no baseline for anything. And from what is being posted, I am not alone.

If this means 90 days from the last submittal (the images), then we wait until 9 July. Right?