Summary impressions of the IVD roundtable meeting held on December 11, 2008, from 9 am to 4 pm, at OIVD, FDA

These are the highlights of the meeting.

What’s new?

Changes in Staff-Steve Gutman, although technically on board until 12/31, is no longer at FDA. Acting Office Director is Don St. Pierre, also head of the search committee. Alberto Gutierrez will be filling in the technical expertise Don lacks. Don said “when Alberto says it, it comes from me, and when I say it, it also comes from Alberto.” Alberto is the scientist, and Don is the policy person. They plan to work closely together.
Jeanne Cooper is moving to the front office, and Courtney Harper will become the Division Director in chem. /toxx.

Don Stated that he will be more conservative that Steve was with respect to policy changes, and expects anyone with an issue with a reviewer to go up the levels in an orderly sequence, and not call him right away.

They will be moving to White Oak in May 2009 (I think they are the last to go.) OIVD has been told that the move will not cause any disruption, but I detected a note of skepticism in the statement

You will see more use of advisory panels for assays employing new technology,
IVD is trying to employ webcasting (they did not say what kind of software would be compatible).

What they are concentrating on, now

Post marketing issues with maltose and glucose monitors- According to Don, they are going to take action here-“labeling is not enough”.

Enforcement is coming for those ASR manufacturers who did not contact FDA with submission plans, and continue to sell ASRs with instructions, etc Also under scrutiny are those others who have re-labeled their product “Research Use Only”

NO comment planned on IVDMIA. Don went out of his way to mention this.

Issues that will affect review times

In general, not much novel gets done in the first year of an administration change. OIVD is afraid there will be a hiring freeze.

Staff is largely “rookies” Majority less than 5 years OIVD time. Don warned us to expect questions about issues that have already been resolved, and asked us to be sure to bring these up with the branch chief, who will have more history about the product.
Noted that some submissions are still coming in without form 3674-(this is the clinical trials registry certification-It’s expected for IVD submissions, but usually, you simply have to check the “not applies” box) If this is not in the submission, the submission will not be filed.

Don gave a plea for use of the electronic “Turbo” 510(k)

Ensuring the quality of IVD submissions. Sally Hojvat gave an excellent presentation on recurring issues with IVD submissions. Items like use of RUO reagents in the procedure and in the labeling, inadequate documentation of quality of the specimens, especially for CA biomarkers, inadequate justification for selection of sample population, and poor conduct of clinical trials (e.g., no monitoring, vague protocols without success criteria, etc.), were all common FDA gripes in all the divisions.

Fate of combination 510K) and CLIA waiver submission. Two of these pilots were done, but neither was as rapid as hoped. Combining the submissions makes it a longer review time. Industry still not happy with protocol for waiver submission-FDA feels the ball is in industry’s court.

All presentations will be on the AMDM website, but since last spring’s presentations are not yet there, I am not sure when these will show up

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