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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities

Version #3
Effective Date: October 15, 2012

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  1. Purpose
    This Standard Operating Policy and Procedure (SOPP) serves as a guide for Center for Biologics Evaluation and Research (CBER) staff to determine the accuracy of information submitted by an applicant relative to user fees for medical devices and to verify that payment owed has been received under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended most recently by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, which reauthorized the Medical Device User Fee Amendments (MDUFA).

 

  1. Scope
    1. This SOPP describes the responsibilities and procedures related to billing applicants for user fees for medical devices, including billing for establishments.
    2. This document identifies other user fee activities for which the Office of Management’s Regulatory Information Management Staff (RIMS) is responsible.

 

  1. Background
    1. The Medical Device User Fee and Modernization Act (MDUFMA) was enacted in 2002 and renewed in 2007 (MDUFA II) and 2012 (MDUFA III).  It authorizes FDA to collect user fees from applicants for certain medical device submissions.
    2. Medical device submissions covered by user fees are those submitted under section 102 of the FD&C Act, as amended by the Medical Device User Fee Amendments of 2012, and include:
      • Premarket Approval Applications (PMAs),  including Product Development Protocols (PDPs), premarket reports (PMRs), panel-track supplements, 180-day supplements, real-time supplements, 30-day notices, and annual reports (ARs);
      • Device BLAs (original) and efficacy supplements (BLSs);
      • 510(k)s;
      • 513(g)s;
      • Establishment Registrations.
    3. The FD&C Act also provides for certain exclusions and waivers of user fees.  See reference section for additional information.
    4. An Electronic Medical Device User Fee Cover Sheet is used to submit information on user fees owed or not owed with all medical device submissions.  It is not used for medical device establishment user fees or PMA annual reports.  A Web link to the cover sheet can be located in the reference section.
    5. Each fiscal year FDA is required to promulgate current medical device user fee rates for the coming fiscal year.  Rates are set for PMAs, PDPs, premarket reports, PMA annual reports, panel-track supplements, 180-day supplements, 30-day notices, real-time supplements, device BLAs and efficacy supplements, 513(g)s, 510(k)s and establishment registration fees. The fees are published in the Federal Register 60 days before the start of the fiscal year.  A link to the current medical device user fee rates can be located in the reference section.

 

  1. Definitions
    1. Applicant - For purposes of this SOPP, in order to be concise the term “applicant” includes sponsors, submitters, applicants, manufacturers, etc.
    2. Blood Establishment Registration (BER) - The CBER database used to track blood establishment and biologic licensed device establishment registrations.
    3. Biologics License Application (BLA) - An application for licensure of a biologic submitted under section 351 of the Public Health Service Act.
    4. Blood Logging and Tracking (BLT) -  The CBER database used to track premarket approval applications (PMA), premarket reports (PMR), supplements, product development protocols (PDP), premarket notification submissions (510(k)s), 513(g)s, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
    5. Device Submission (Submission) - Any correspondence that includes information and/or data relevant to the premarket review of a medical device; including but not limited to 510(k)s, PMAs, BLAs, supplements and/or amendments to a pending file, etc.
    6. Efficacy supplement - A biologics license supplement with user fee-defined clinical data.
    7. Establishment Registration Fee - A fee due to FDA once each fiscal year either upon the initial registration of the establishment or upon the annual registration under section 510 of the Food, Drug, and Cosmetic Act.
    8. FDA’s Unified Registration and Listing System (FURLS) - The Agency database used to track electronic device establishment registrations and listings (other than those registered in BER).
    9. In Arrears for Non-payment of Fees - An applicant will be determined to be in arrears for any medical device user fee owed the federal government if that applicant has not paid the fee specified in the Federal Register annually according to the type of submission.
    10. Incomplete and unacceptable for filing - If a fee is not paid, the fee liable device submission shall be considered incomplete and shall not be accepted for acceptance review or filing until the fee is paid in full.  The Food and Drug Administration (FDA) will not begin its review of a device submission until the fee for that submission is paid and all fees for previous submissions have been paid.
    11. MDUFA Unpaid Cover Sheet Report -  A daily report from the FDA’s Office of Financial Management (OFM) sent via e-mail to the Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Review (CBER) Office of Management (OM)/RIMS which shows CBER and CDRH regulated applicants that have submitted MDUFA cover sheets but have not submitted the payment.
    12. MDUFA Payment Report -  A daily report from OFM sent via e-mail to CDRH, CBER/OM/RIMS, CBER/ Office of Blood Research and Review (OBRR), and CBER/ Office of Cellular, Tissue and Gene Therapies (OCTGT) which shows payment made by applicants for incoming CBER submissions.
    13. Panel-track supplement - A supplement to an approved premarket approval application or premarket report under section 515 that requests a significant change in design or performance of the device, and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness. A panel track supplement may be filed to an existing PMA, PMR, or PDP.
    14. Payment Identification Number (PIN) - Each submission requiring a fee under MDUFA must be assigned a unique payment identification number (PIN).  The PIN is automatically generated after an applicant completes and prints the Medical Device User Fee Cover Sheet.  A Web link for the cover sheet can be located in the reference section.
    15. Premarket Approval Application (PMA) - Any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. (21 CFR 814.3(e))
    16. Premarket Approval Application (PMA) Annual Report - A post approval report which summarizes information pertaining to the original PMA and any subsequent PMA supplements.  Annual reports are required to be submitted at intervals of one year from the date of approval of the original PMA.
    17. Premarket notification -  A submission that is formatted consistent with 21 CFR 807.87 and submitted under Section 510(k) of the FD&C Act by a device manufacturer or his agent to FDA at least ninety days before introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use. Also known as a “510(k) submission.”
    18. Premarket reports (PMRs) - A premarket application for a reprocessed single-use device.
    19. Product Development Protocol (PDP) - Mechanism for the regulation of Class III medical devices that would allow an applicant to come to early agreement with the FDA as to what would be done to demonstrate the safety and effectiveness of a new medical device.
    20. Real-time supplement - A supplement to an approved PMA, PMR, or PDP under section 515 that requests a minor change to a medical device.  Example:  a minor change to the design of the device, software, manufacturing, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.
    21. Regulatory Management System/Biologics License Application (RMS-BLA) - The CBER database used to track biologic license applications and related submissions, including licensed device applications and efficacy supplements.
    22. Submission -For the purpose of this SOPP, in order to be concise the term “submission” will be used for any user fee liable application, supplement, report, or submission.
    23. 180-day supplement -  A supplement to an approved premarket approval application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additive, and labeling.  Includes PMAs, PMRs and PDPs.
    24. 510(k) -  A submission made to the FDA prior to marketing a medical device to demonstrate that the device to be marketed is at least as safe and effective (that is, substantially equivalent (SE)) to a legally marketed device that is not subject to premarket approval. See also the definition in Q.
    25. 30-day notice - A supplement to an approved premarket approval application or premarket report under section 515 that involves modifications to manufacturing procedures or method of manufacture.  If the 30-day notice is not adequate, but contains data that meets appropriate content requirements for a PMA supplement, then the 30-day notice will become a 135-day supplement.
    26. 513(g) - A request for information regarding the class in which a medical device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

 

  1. Policy
    1. Submissions:
      1. Each submission, except PMA annual reports, should be accompanied by the Medical Device User Fee Cover Sheet.The cover sheet is created on-line by the applicant; the payment identification number (PIN) is electronically generated.  A completed cover sheet should be electronically transferred by the applicant to OFM before payment is sent.
      2. A check, bank draft, or U.S. postal money order along with a copy of the completed cover sheet should be sent to the FDA through the U.S. Bank.  The PIN must be written on the check.  Applicants also have the option to make online electronic payments via Automated Clearing House (ACH) which is an electronic debit from a checking or savings account.  Applicants may register for electronic payments through Pay.gov.
      3. The user fee must be paid to FDA through the U.S. Bank and will not be considered paid until receipt of payment has been verified by OFM. 
      4. Volume 1 of each submission requiring a fee under MDUFA, except PMA annual reports, should be accompanied by the Medical Device User Fee Cover Sheet.
      5. In no case should payment be submitted with the premarket submission.  The review clock does not start until verification of payment.
    2. Establishments:
      1. Each establishment involved in the manufacture and distribution of medical devices intended for commercial distribution in the United States should register annually with the FDA.  Medical device establishments that register must pay an establishment registration fee.  A unique payment identification number (PIN) will be assigned when registering electronically through FDA’s Unified Registration and Listing System (FURLS).  FURLS will generate an establishment registration invoice that should be printed.  See reference section for a link to the registration website.
      2. Registrations are required to be submitted electronically unless FDA grants a waiver. 
      3. The registration fee must be paid before submitting the establishment registration electronically.  A payment identification (PIN) and a payment confirmation number (PCN) will be received for payment and are required before proceeding with the registration.
        1. A check or wire transfer, along with a copy of the invoice should be sent to the FDA at P.O. Box 979108, St. Louis, MO.  This is a different address than the payment of submission and annual report fees. 
        2. If check is sent by a courier to a street address, the address is U.S. Bank, Attn: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101.  The PIN must be written on the check.
        3. Applicants also have the option to make online electronic payments via Automated Clearing House (ACH) which is an electronic debit from a checking or savings account.  Applicants may register for electronic payments through Pay.gov.
      4. CBER licensed biologic devices are required to register electronically through the BER system.  BER does not create payment cover sheets with unique identifiers; therefore, RIMS will send annual invoices to licensed device establishments after the December registration due date. 
    3. PMA Annual Reports
      Invoices for PMA annual reports are sent at the end of each quarter in which the PMA annual report is due.  Payment details are included on the invoice.

 

  1. Responsibilities
    1. FDA/Office of the Commissioner (OC)
      Annually establishes MDUFA user fee rates and publishes them in the Federal Register
    2. FDA/ Office of Financial Management (OFM)
      1. Receives notice of MDUFA payments from the U.S. Bank
      2. Sends daily notification of MDUFA Payment Report to RIMS
      3. Sends daily MDUFA Unpaid Coversheet Report to RIMS
      4. Generates device establishment user fee invoices for CBER license device establishments
    3. CBER’s Regulatory Information Management Staff (RIMS)
      1. Posts current user fee rates in CBER Outlook public folder
      2. Reviews CBER payment check receipt reports received from OFM and verifies proper payment for submissions
      3. Coordinates with appropriate Regulatory Project Manager (RPM) to resolve payment discrepancies
      4. Confirms automated system update and notifies office designated contact and RPM of payment by applicant when the firm listed on MDUFA Unpaid Cover Sheet Report submits payment
      5. Monitors status of all submissions that have been designated as incomplete and unacceptable for filing
      6. Updates user fee payment information if necessary
      7. Sends invoices for PMA annual reports and licensed device establishment registration user fees
      8. Serves as primary point of contact for questions or challenges regarding user fee assessments
      9. Other User Fee Activities for which RIMS alone is responsible (procedures are not included in this SOPP)
        1. Bills licensed device establishments for annual registration fee
        2. Sends invoices for PMA annual reports
        3. Responds to waiver and refund requests for biologic devices
        4. Responds to inquiries from the review offices and the public on user fee issues
        5. Produces a number of reports on user fee receipts and performance
    4. RPM - Regulatory Project Manager(s) in the review office (or office designee)
      1. Receives medical device submission and determines type of application/submission
      2. Checks Medical Device User Fee Cover Sheet for accuracy and completeness; if missing, inaccurate or incomplete, RPM contacts applicant to resolve
      3. Faxes or electronically sends cover sheet to RIMS (301-827-2875) if:
        • There is any discrepancy in the cover sheet or payment that was not resolved by contacting the applicant
        • The submission is for a licensed product.
      4. Ensures payment is received from applicant for submission before the review begins
      5. Notifies applicant of payment discrepancies and follows through to resolution; coordinates with RIMS as appropriate>
      6. Notifies applicant by faxing Incomplete: Unacceptable for Filing letter alerting applicant that payment has not been received for the submission and the review will be put on hold
      7. Notifies review committee when submission is incomplete and unacceptable for filing that review will not begin
        • The designated review office will alert reviewers that the applicant should not be contacted under any circumstances and review should not be initiated until further notice from the RPM that payment has been received and review can begin
      8. Ensures communication for Incomplete: Unacceptable for Filing letter is entered in BLT database if submission is for a non-licensed device, e.g., PMA, PMR, PDP, 510(k) 
        When the submission is a biologics license application or an efficacy supplement, the RPM will enter an Unacceptable for Filing letter into the RMS-BLA.
      9. Ensures that the review clock is automatically stopped upon issuance of an:
        • Incomplete: Unacceptable for Filing letter for a non-licensed device, e.g., PMA, PMR, PDP, 510(k)
        • Unacceptable for Filing letter for a license application or an efficacy supplement
      10. When notified by RIMS that the applicant is up-to-date on payments
        • Activates acceptance review if the submission is a 510(k) or PMA
        • Activates review and generates an Acknowledgement letter and either faxes the letter to the applicant or ensures Regulatory Information Specialist (RIS) or Consumer Safety Technician (CST) faxes the letter to the applicant, if the submission is a BLA or Efficacy BLS
      11. Ensures review clocks are reset after receipt of payment. 
        • BLT automatically resets clock upon payment
        • RPM will notify RIMS to manually change review clock in RMS-BLA.
      12. Ensures that device facility information is correctly entered into RMS-BLA for licensed devices.
    5. Blood Establishment Registration Coordinator
      Ensures that information on registration and products is entered properly and accurately

 

  1. Procedures
    1. Routine Processing of Submission Cover Sheets
      1. Process incoming submissions. [CBER DCC]
        1. Forward the Medical Device User Fee Cover Sheet to the appropriate review office.
        2. Retain the original Medical Device User Fee Cover Sheet with the original copy of the submission
      2. Review the Medical Device User Fee Cover Sheet and verify that any exclusions checked on the cover sheet are accurate (e.g., first PMA submitted by a qualified small business, pediatric supplement only, for further manufacturing use only, state or federal government entity).  [RPM]
      3. Assign a Submission Tracking Number (STN) to the submission following Center and Office standard operating procedures for BLAs and BLA efficacy supplements, PMAs, PMRs, PDPs, PMA annual reports, panel-track supplements, 180-day supplements, 30-day notices, real-time supplements, 510(k)s, and 513(g)s. [RPM/CST]
      4. Compare the Medical Device User Fee Cover Sheet with the submission to determine if the submission is subject to user fees.  [RPM]
        1. If the submission is NOT subject to fees follow standard procedures to assign an STN and continue the review process.
        2. If the submission is subject to fees confirm with RIMS that payment has been received for the submission.
        3. Review of the submission should begin only if full payment has been received.  If the payment was received and there is a discrepancy in the amount received, notify the applicant of the correct amount to be submitted or refunded.
        4. If the submission is subject to fees and the applicant has not paid the user fees, go to Failure to Submit Payment section below.
    2. Submissions Received Without a Medical Device User Fee Cover Sheet or with an Incomplete Medical Device User Fee Cover Sheet
      1. Contact the applicant by telephone to ask the status of cover sheet and payment. [RPM]
        1.  If the cover sheet was just omitted but payment was made, request immediate completion of the form from the FDA’s Internet Web page; request a faxed copy. 
        2. If the applicant failed to pay, issue an Incomplete; Not Acceptable for Filing letter and notify the applicant that the submission is on hold and payment must be received within 30 days or FDA will consider the submission withdrawn.
      2. Incomplete or inaccurate forms submitted with a submission:
        1. Contact the applicant by telephone to obtain the necessary information or relay the inaccuracy. Request that the applicant create a new Medical Device User Fee Cover Sheet.  [RPM]
        2. Notify RIMS of the new PIN when the new Medical Device User Fee Cover Sheet is received. [RPM] 
        3. Contact the FDA/OFM to have the funds transferred to the new PIN. [RIMS]
          Note: A submission should not be reviewed or proceed to an acceptance review or filing action until the information and payment are obtained.
    3. Failure to Submit Payment
      1. If no payment or partial payment is received:
        1. Notify the review committee that review is on hold and the applicant should not be contacted about the submission under any circumstances (the designated review office should attach an orange cover sheet to the submission to flag the on-hold status). [RPM
        2. Notify the applicant by telephone that the submission is incomplete and unacceptable for filing. [RPM]
        3. Prepare a notification letter using the CBER Incomplete: Unacceptable for Filing letter template. [RPM]
          1. When the RPM creates an STN for a non-licensed medical device submission that doesn’t have a PIN, a communication automatically gets entered into BLT for payment not received. This entry changes the status of the submission to clock stopped/awaiting response.
          2. When the RPM creates a user fee STN for a license application or efficacy supplement which is not accompanied by a Medical Device User Fee Cover Sheet, the RPM issues an Unacceptable for Filing letter and contacts RIMS to manually stop the review clock as of the receipt date (this is because RMS-BLA currently uses PDUFA schedules).  When payment is received for license applications or efficacy supplements, the RPM notifies RIMS to start the clock using the payment receipt date.
    4. Notification that fees owed have been paid
      1. Notify the review office that fees owed have been paid. [RIMS]
      2. Notify the committee that the review process may begin. [RPM]
      3. Instruct DCC to forward the submission to the committee, as applicable. [RPM]
      4. Prepare and fax to the applicant an Acknowledgement letter using the most recent approved letter template on CBER’s Intranet if the submission is a BLA or Efficacy BLS. [RPM]
      5. Ensure that the user fee action due dates are reset. [RPM]
        1. BLT system automatically generates correspondence for non-licensed devices, e.g., PMAs, PMRs, PDPs, 510(k)s, with a purpose of Full Payment Received which restarts the clock.  BLT automatically calculates the new action due dates based on the received payment date.
        2. Contact RIMS to manually reset the clock for BLAs or efficacy BLSs in RMS-BLA.
    5. Processing of Device Establishment Registration Payment
      1. Send annual invoices to licensed device establishments after the December registration due date. [RIMS]
      2. Ensure facility and product information is accurately entered into the CBER regulatory databases. [RPM]
    6. Processing of PMA Annual Report Payment
      Send invoices to PMA holders at the end of the quarter in which the PMA annual report is due. [RIMS]

 

  1. Appendix
    N/A

 

  1. References
    Web links to the references below can be found in the list following the History Table.
    1. Exclusions and waivers of user fees
    2. Medical Device User Fee Cover Sheet
    3. User Fee Rates
    4. Device Registration
    5. User Fee Financial Support Team - userfees@fda.gov

 

  1. History
Written/RevisedApproved ByApproval DateVersion NumberComment
Reed, Kochman, HamillRobert A. Yetter, Ph.D.Oct 3, 20123Updated to include changes in MDUFA III
Daria ReedRobert A. Yetter, Ph.D.May 6, 20102

Updated to include changes in MDUFA II

Daria ReedRobert A. Yetter, PhDJan 12, 20051Original version; Written jointly with RMCC Device Review Subcommittee