Grapefruit USA Inc (GPFT)

[IMGG4TP]

IMGGorBUST...................FYI.

Please review the following excerpts taken from the below linked publications ( I have highlighted portions that are pertinent to our previous discussion concerning 510K approval routing and authorization):

1. Division Acceptance and Review

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm


After the 510(k) is logged in by the Document Mail Center, the 510(k) is sent to the appropriate ODE or OIVD reviewing division for the type of device. Delivery to the proper reviewing division will be facilitated by completing information on the Cover Sheet and Cover Letter, such as, advisory panel, Code of Federal Regulations reference, and product code.

2. Radiology Devices Move To OIVD

http://www.medicaldevicestoday.com/2010/02/radiology-devices-move-to-oivd-more-cohesive-dx-reviews-ahead-.html

FDA hopes that shuttling its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety will produce more cohesive policies on diagnostic device review.Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment as well as other radiation-emitting devices, have been a source of high-profile tensions within the Office of Device Evaluation, but the agency says the move responds to long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA.FDA Commissioner Margaret Hamburg signed the orders in January that officially moved the review branch from its current home in ODE to a new spot in OIVD (The Gray Sheet' Jan. 25, 2010)."We found that we were drifting somewhat in how OIVD was regulating diagnostics and how some of the ODE was doing some of their diagnostics," explained OIVD Director Alberto Gutierrez.OIVD will now house four product divisions - the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and, now, radiological devices.The center originally tried to deal with the disparities by maintaining a core group of statisticians that worked with both offices, he said."They kind of acted as a go-between," he explained, but "that just didn't seem to be doing the job as well as we would like.

In summary, the reviewing division for the I3 application is the Division of Radiological Devices within the OIVD and, according to the above linked FDA document, the application was sent to that division from the mail center for review.

3. Decision Letter Issued

The decision letter will be mailed and faxed, if a fax number has been provided, to the submitter upon receipt of the completed 510(k) from the reviewing division.

Thus, the reviewing division of the I3 application, the Division of Radiological Devices, will forward the decision letter to the mail center for sending or faxing to I3.

Now, the question is who actually will make the final decision.

4. I refer you the 5:54 minute mark of the video " View the 510(k) Process Video" contained in the above FDA link, where it is stated:

"After the reviewing division completes the scientific review and corresponding documentation, a decision letter is forwarded through supervisory channels to the division director. If he or she agrees with the determination, the letter is signed, logged out of the division, and brought to the document mail center for dating and final processing."

Thus, it is the director of the Division of Radiological Devices, within the OIVD, who is responsible for making the final decision.

Finally, who is the director of the Division of Radiological Devices?

5. http://www.fda.gov/aboutfda/centersoffices/cdrh/cdrhoffices/ucm127854.htm

Division of Radiological Devices Donald St. Pierre* (acting) 301-796-5454


In conclusion, you will notice that nowhere in the aforereferenced publications are the names “CDRH” and “Jeff Shuren” mentioned as having anything to do with the 510K approval process.

*A telephone call to the office of the Division of Radiological Devices revealed that Donald St. Pierre has since been replaced by David Brown, Ph.D.

GL