Diagnostics & Imaging Week Washington Editor
WASHINGTON — The newly crafted agreement between industry and FDA regarding medical device user fees is on paper and ready for presentation to Capitol Hill. And a review of the document and a conference call with officials at the Advanced Medical Technology Association (AdvaMed; Washington) indicates that the proposal includes mostly small alterations and little radical change.
Unveiled by AdvaMed yesterday, the proposed schedule features lower user fees for small companies on their first submissions and a slight tightening of timelines for reviews by the agency, the two features sure to draw the most interest by the industry.
Based on the stated timelines, FDA said that it will attempt to provide decisions for 60% of conventional pre-market applications (PMAs), and supplemental applications “that go before an FDA advisory committee,” within 180 days.
And the agency will attempt to render a decision for lower-risk devices requiring 510(k) approvals within 90 days for 90% of those applications, and all but 2% within 150 days.
History suggests that the agency might be optimistic in its projections.
In a March meeting last year, FDA officials said that the agency would not push itself further to meet the more ambitious goals then in effect for PMAs, namely returning a decision on half of such filings within 180 days.
At that session, Linda Kahan, the deputy director of the Center for Devices and Radiological Health, told Diagnostics & Imaging Week that a concomitant objective, that of issuing a major deficiency letter within 150 days, left FDA and applicants with only 30 days to resolve deficiency issues.
She said that this pressure may have resulted in companies being too hasty in their filing work, and she was concerned that the agency’s “being forced to make a decision [would] result in more products not being approved.”
The new fee schedule for small companies is somewhat less demanding than before, with first 510(k) applications being reduced from 80% of the full fee of $3,404 to half the full fee — that is, $1,702.
For first-time PMAs and PMA supplements, firms grossing less than $100 million would pay only a quarter of the full fee, down 13 percentage points from the 38% of the full fee imposed by MDUFMA.
This reduction comes out to a fee of $46,000 vs. the full fee of $185,000.
FDA also reported that it will draft a new guidance for in vitro diagnostics (IVDs), including a provision that would exempt some low-risk IVDs from FDA scrutiny. However, this presumably would not include most IVDs employing multi-variate assays, which are the subject of a guidance the agency published earlier this year that will impose a quality systems regulatory scheme on this class of diagnostics.
This effort is based in part on the common use of computer software logarithms, which the agency has historically subjected to regulatory scrutiny.
According to the published document, FDA intends to conduct a pilot program to evaluate whether it can integrate “the 510(k) review and Clinical Laboratory Improvement Amendments [CLIA] waiver review process” — the latter being the domain of the Centers for Medicare & Medicaid Services — “for possible increased efficiencies.” FDA would track its performance on this approach and, after two years, decide “whether user fees and performance goals for CLIA waivers should be considered.”
In a conference call to discuss the new MDUFMA proposal, Stephen Ubl, said: “our understanding is that they [PDUFA and MDUFMA] would be marked up together,” with the first review to take place tomorrow in the Senate Health, Education, Labor and Pensions Committee. That hearing is set for 10 a.m. in the Senate Dirksen office building, but a witness list was not available at press time yesterday. Ubl said he was not certain which House committee would be the first to see the proposal.
Janet Trunzo, executive VP for quality and regulatory affairs at AdvaMed, said that the changes to the third-party inspection system consisted of “a lot of little procedural things.”
“FDA always retains the authority to go in and inspect,” but “the likelihood of you getting an inspection is very slim” unless the third party’s report suggests that an FDA audit would have resulted in an official-action-indicated (OAI) rating.
The third-party inspection program has not performed up to expectations in the past. Congress penciled in a provision for this under the original MDUFMA bill, but a Government Accountability Office (GAO) report submitted to Congress in January disclosed that by the end of last October, only nine of the organizations that sought accreditation for inspections had bothered to train and certify their inspectors.
FDA also proposes to draft a guidance for “diagnostic imaging devices that are sometimes used concurrently with diagnostic drug and biological products,” such as contrast agents and radiopharmaceuticals that are typically employed as “concomitant use products.”
By the end of FY08, the agency will publish a draft guidance on how it will handle these devices in a way that reflects the kind of inter-center consultation that currently deals with regulatory questions surrounding combination products. Assuming all goes well, the final guidance would follow within a year.