The clinical lab community will for the first time join traditional device and imaging equipment makers in FDA user fee reauthorization talks, but members are not quite ready to concede to agency oversight.

Joining this year's negotiations is the American Clinical Laboratory Association (ACLA), representing 44 member companies including independent clinical laboratories and hospitals labs.

As usual, AdvaMed, the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance also are representing their respective member companies during the negotiations with FDA.

The user fee agreement must be reauthorized by September 2012.

Lab-developed tests are not currently subject to FDA review, and save for a few labs or firms that have filed pre-market applications for their tests, labs are generally unfamiliar with the agency's user fee process.

But with efforts underway to develop an oversight framework for lab-developed tests and require FDA pre-market review for at least a portion of them, the agency invited ACLA to participate in this round of user fee discussions. (See " Also see "Expanded FDA Lab Oversight May Result In Relaxed Regs For Some Test Kits" - Medtech Insight, 26 July, 2010. " – "The Gray Sheet" July 26, 2010.)

"We have crossed a threshold with the lab-developed tests," said Malcolm Bertoni, assistant commissioner for planning and director of the office of planning in the FDA Commissioner's office, who is leading the medical device user fee reauthorization efforts. "The agency has had a position that lab-developed tests are medical devices."

"Because there are some laboratories [that] have submitted applications and paid fees more or less in accordance with FDA's interpretation of the law, we did invite the American Clinical Laboratory Association to join the discussions," Bertoni said Feb. 10 at the Health Leaders Dialogue in Washington, D.C.

Uncertainties Pose Challenges

According to David Mongillo, vice president for policy and medical affairs at ACLA, the association weighed the decision carefully but ultimately decided it was in clinical labs’ best interest to have a seat at the table.

“Even though the details of FDA’s oversight of [lab-developed tests] have not been articulated, if FDA’s assertions are implemented, it would expose clinical laboratories to user fees," Mongillo said in an interview. "We felt that it’s important that we are represented during the negotiations.”

FDA could establish shorter timelines for reviewing 510(k) and PMA submissions for lab tests, ACLA says.

Until more is known about FDA's strategy for regulating lab-developed tests – for instance, how many types of tests and how many labs would become subject to FDA oversight, and when regulation would begin – it is difficult to say how proposed user fees would impact the lab community, Mongillo explained.

"We've proposed a couple of ways that the MDUFA negotiations could take that into consideration," he said.

On the one hand, FDA could establish different, shorter timelines for reviewing 510(k) and PMA submissions for lab tests, as well as a separate establishment registration fee, ACLA suggested at the first user fee negotiation meeting Jan. 26.

Or, the agency could finalize a user fee agreement under current FDA policy and scope, and simply revisit that agreement once the lab-developed test oversight framework is available, the association proposed.

FDA noted that "depending on the progress and timing of FDA policy development in this area, these issues may be considered during the course of [user fee] reauthorization discussions," according to agency minutes from the meeting.

"It does present a challenge because there are a lot of uncertainties," Bertoni conceded. "We thought it was important, if they were going to be affected by any possible changes in policy, to give them a voice in these discussions."

"New Kids On The Block"

Another challenge for clinical labs is the sheer learning curve factor of joining in on negotiations where the other players have two rounds of prior experience.

"They're the new kids on the block," Bertoni said. "They're coming up to speed."

"Given this is ACLA's first MDUFA negotiation, we're learning as we go along," Mongillo noted.

The association brought along representatives from Quest Diagnostics and Laboratory Corporation of America to the discussions.

ACLA emphasized that participation in the user fee discussions should not be interpreted as an acceptance of its regulatory fate.

"We're not trying to say that just because we're participating, we have acquiesced to the assertion that FDA has authority over the regulation” of lab-developed tests, Mongillo concluded.

By Jessica Bylander

Clinical Labs Join Medical Device User Fee Negotiations

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