Originally published July 15.
By Turna Ray
The US Food and Drug Administration plans to release three separate guidances on its regulatory framework for laboratory-developed tests, the agency recently told diagnostics industry representatives during a meeting to negotiate medical device user fees.
According to FDA's minutes of a June 27 meeting with industry to discuss the reauthorization of the Medical Device User Fee Amendments, agency officials told device and laboratory industry leaders that there will be "three guidance documents coming out together that will detail the proposed road forward in oversight of laboratory developed tests."
One guidance will lay out the agency's overarching regulatory plan for LDTs; one will elucidate how the agency plans to assess the LDT field; and another will "help laboratories understand the differences and similarities" between the Clinical Laboratory Improvement Amendments and FDA's Quality System Regulations.
The goal of the MDUFA III negotiation meetings is to assess FDA's work related to ensuring the safety and effectiveness of medical devices and to settle on the level of funding that the device and diagnostics industry has to pay to help the agency maintain its performance. The meetings are attended by industry officials from AdvaMed, the Medical Imaging Technology Alliance, the Medical Device Manufacturers Association, and the American Clinical Laboratories Association. FDA is represented mainly by leaders from the Center for Devices and Radiological Health, but associates from other departments are also present.
According to FDA's minutes, industry representatives expressed concern during the June 27 meeting that with a greater regulatory burden due to FDA oversight of LDTs, the agency may not be able to meet its performance goals. "FDA reiterated its plan to address LDTs through a risk-based, phased-in approach, and therefore the agency does not expect a large impact on workload," the meeting minutes note. "FDA’s plan for LDTs will be published as guidance and will have a comment period."
After the FDA announced its intent to lift its longstanding policy of "enforcement discretion" over LDTs, it held a hearing a year ago to solicit public input on the matter. At the same meeting, agency officials said the agency was considering several ideas, such as downgrading the risk classification of certain regulated tests; phasing in regulation of LDTs that aren't currently regulated; collaborating with the National Institutes of Health to develop a test registry that could serve FDA's purposes for keeping an eye on all test developers; and possibly enlisting the help of third-party inspectors to help the agency with its increasing regulatory responsibilities (PGx Reporter 07/21/2010).
During several MDUFA meetings, which have been ongoing since the beginning of the year, industry members have asked FDA for greater clarity on the workload and resources it will require to facilitate a number of device-related initiatives, including changes to the 510(k) device clearance process and the agency's plans to regulate LDTs. According to the latest meeting minutes, industry players involved in the negotiations have not agreed to FDA's MDUFA proposal, under which it intends to collect approximately $770 million per year from device manufactuers.
"They do not agree with FDA’s proposed baseline [of $770 million], which could result in an increase of 17 percent from FY 2012 collections to FY 2013 collections in order to maintain projected FY 2012 user fee spending levels with 4 percent inflation," the meeting minutes note. Moreover, industry reps did "not support MDUFA III user fees comprising 40 percent of the device review budget (i.e., the process for the review of device applications)," expressing their concern that "user fees [are] becoming too large a percentage of the overall budget."
Given FDA's claim that its risk-based, phased-in regulatory framework will not substantially increase its workload, ACLA said that it wants to include a statement in industry's MDUFA commitment letter that specifically states that "LDTs would not be included in MDUFA III if there is truly a minimal impact on workload."
According to the minutes of the June 1 MDUFA meeting, ACLA suggested that once FDA finalizes its regulatory framework for LDTs, the agency should instate lower fees for laboratories submitting LDTs for review by the agency, since "clinical laboratories would be subject to MDUFA user fees as well CLIA fees." ACLA does not want user fees to apply to LDTs until FDA has issued its regulatory framework for such tests.
"Once the regulatory framework is established, ACLA wishes to see FDA reopen negotiations with the clinical laboratory sector," according to the meeting minutes.
Additionally, as noted in the meeting minutes for the May 4 meeting, if FDA intends to regulate LDTs as medical devices, ACLA wants FDA to establish different performance goals with faster timeframes for LDTs, and a phase-in period for the fee structure.
Separately, ACLA is taking steps to advance a legislative proposal that would keep LDTs under CMS' oversight. The lab industry group has proposed that LDTs continue to be overseen by CMS, with enhancements to its regulatory powers, such as giving the agency the funding and staff to review the clinical validity of LDTs (PGx Reporter 05/04/2011). ACLA believes it has sufficient support within the laboratory community for such a plan, and has said that LDT reviews by CMS could potentially be funded with 100 percent user fees.
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