The FDA-industry device user fee agreement is finally on paper and in public view. And FDA has scheduled a public meeting on the proposal for March 28.

The agency issued its draft commitment letter and draft legislative language for user fee reauthorization March 15, two months after FDA was, by statute, supposed to have sent a final set of recommendations to Congress. In addition to the public meeting at the end of the month, the agency will accept public comment on the documents through April 16.

FDA and industry actually formalized the agreement in mid-February. The proposals have since gone through review at the upper levels of HHS and at the Office of Management and Budget. (See Also see "Industry, FDA Agree On Draft User Fee Commitment Letter" - Medtech Insight, 5 March, 2012..)

“After the public meeting and public comment period, FDA will revise the draft recommendations as necessary.”

“After the public meeting and public comment period, FDA will revise the draft recommendations as necessary,” the agency states in its announcement of the March 28 public meeting.

The agency also plans to present its draft recommendations to the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee, which will need to incorporate the legislative proposals into a user fee reauthorization bill that needs to be enacted by Sept. 30, when the current program expires. Draft legislation is already being circulated in the House and Senate without the device fee provisions, but including other FDA device regulatory reforms. (See in this issue, Also see "Draft User Fee Bills Aim To Streamline And Strengthen Device Regs" - Medtech Insight, 19 March, 2012..)

The substance of the newly released documents has previously come to public view in the context of negotiation meeting minutes that have been periodically posted online by FDA.

As previously reported, industry has agreed to pay $595 million (plus inflation) in user fees from 2013 to 2017, about double the five-year total through fiscal 2012. In return, FDA has incorporated some stricter pre-market review performance goals that put increased emphasis on early interaction by reviewers with device application sponsors, the total time to market for a device, and following up on applications that are not completed within performance-goal timelines. (See Also see "Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees" - Medtech Insight, 6 February, 2012..)

In particular, the draft commitment letter describes “substantive interaction” goals that commit reviewers to communicating any major issues with an application or the absence of major issues within a two-to-three-month period following a submission. It also introduces new “shared outcome goals” to track total time from submission to final decision, alongside the standard goals based only on FDA-review days.

FDA has also agreed to contract with an outside party next year to perform an independent assessment of the device review process, provide reform recommendations and follow up to evaluate the agency’s success in implementing the recommendations.

Further, the agreement lays out a more structured process for pre-submission meetings with companies. FDA also agreed to request reauthorization of the third-party pre-market review program, which can be used by companies to have some 510(k) submissions reviewed by outside accredited groups instead of FDA. But the user fee agreement does not include funds explicitly directed to either the pre-submissions or third-party review programs.

Central to the agreement for increased user fees is accelerated hiring efforts at CDRH and expanded training efforts. FDA has said it will hire more than 200 new employees based on the device user fee funding. And in its proposed legislative language, the agency seeks streamlined hiring authority.

New Fee Amounts

According to the draft statutory language, the standard PMA submission user fee beginning next fiscal year would be $248,000, increasing to $269,443 in fiscal 2017. As with the current user fee program, all of the other submission-based fees are set at percentages of the PMA fee. For instance, the panel-track supplement fee remains at 75% and the 180-day supplement fee at 15% of the PMA amount.

The 510(k) submission fee has been increased from 1.84% in the current program to 2% of the PMA fee in the proposal. The standard 510(k) fee will reach $5,369 by fiscal 2017. (See Also see "Shuren Defends Tentative User Fee Agreement On The Hill" - Medtech Insight, 20 February, 2012..)

As with the current program, small businesses reporting $100 million or less in revenue will pay a reduced fee rate. And companies with $30 million or less in revenue can have the fee waived for their first ever PMA submission.

The agreement also maintains a fee waiver for device applications solely for pediatric indications.

New in the proposal is discretionary fee waiver and fee reduction authority for FDA, which was added so reviewers could waive fees for laboratory-developed test submissions that come in under the agency’s yet-to-be released regulatory framework for those assay services. (See Also see "FDA Agrees To Waive User Fees For Reviews Of Lab-Developed Tests" - Medtech Insight, 5 March, 2012..)

The agreement also continues collection of device establishment registration fees, which were instituted in fiscal 2008 to improve the stability of year-to-year CDRH user fee funding. The establishment registration fee would be $2,575 in fiscal 2013, increasing to $3,872 by 2017.

FDA and industry have also agreed to remove some current exemptions from the registration fee. According to minutes posted March 15 from a Feb. 28 meeting between FDA and patient and consumer group stakeholders, the number of fee-paying establishments would increase from about 16,000 currently to about 22,000.

FDA Sets March 28 Date To Discuss Newly Published Draft User Fee Pact

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