Medical Device User Fee Amendments

Medical Device User Fee Amendments

Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.

User fees were renewed in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), and 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III).

The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for MDUFA IV. Once final, MDUFA IV will be in place from Oct. 1, 2018 until Sept. 30, 2022.

MDUFA III

MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market.

MDUFA III is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives. Under MDUFA III, the FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over five years. With this additional funding, the FDA will be able to hire more than 200 full-time-equivalent workers over the course of MDUFA III.

MDUFA IV: Performance Goals - Fiscal Years 2018 Through 2022

• Pre-Submissions
• FDA will continue the Pre-Submission program as described in the Guidance on “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff”.
• Original Premarket Approval (PMA), Panel-Track Supplements, and Premarket Report Applications
• The performance goals in this section apply to all Original Premarket Approval, Panel-Track Supplements, and Premarket Report Applications, including those that are accepted for priority review.
• 180-Day PMA Supplements
• FDA will communicate with the applicant through a Substantive Interaction within 90 calendar days of receipt of 95% of submissions. FDA will issue a MDUFA decision within 180 FDA Days for 95% of submissions.
• Real-Time PMA Supplements
• FDA will issue a MDUFA decision within 90 FDA Days for 95% of submissions.
• De Novo Submissions
• FDA will issue draft and final guidance that includes a submission checklist to facilitate a more efficient and timely review process.
• 510(k) Submissions
• FDA will communicate with the applicant regarding whether the submission has been accepted for review within 15 calendar days of receipt of the submission. For those submissions that are not accepted for review, FDA will notify the applicant of those items necessary for the submission to be considered accepted.
• CLIA Waiver by Application
• FDA will engage in a Substantive Interaction with the applicant within 90 days for 90% of the applications. Industry will inform FDA that it plans to submit a dual submission (510(k) and CLIA Waiver application) during the Pre-Submission process. FDA will issue a decision for 90% of dual submission applications within 180 FDA days.
• Original Biologics Licensing Applications (BLAs)
• FDA will review and act on standard original BLA submissions within 10 months of receipt for 90% of submissions.
• FDA will review and act on priority original BLA submissions within 6 months of receipt for 90% of submissions.
• BLA Efficacy Supplements
• FDA will review and act on standard BLA efficacy supplement submissions within 10 months of receipt for 90% of submissions.
• FDA will review and act on priority BLA efficacy supplement submissions within 6 months of receipt for 90% of submissions.
• Original BLA and BLA Efficacy Supplement Resubmissions
• FDA will review and act on Class 1 original BLA and BLA efficacy supplement resubmissions within 2 months of receipt for 90% of submissions.
• FDA will review and act on Class 2 original BLA and BLA efficacy supplement resubmissions within 6 months of receipt for 90% of submissions.
• BLA Manufacturing Supplements Requiring Prior Approval
• FDA will review and act on BLA manufacturing supplements requiring prior approval within 4 months of receipt for 90% of submissions.