Medical Device User Fee Rates for Fiscal Year 2022 (2022)

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Food and Drug Administration, HHS.

Notice.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2022, which apply from October 1, 2021, through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

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For information on Medical Device User Fees: https://www.fda.gov/​industry/​fda-user-fee-programs/​medical-device-user-fee-amendments-mdufa.

For questions relating to the MDUFA Small Business Program, please visit the Center for Devices and Radiological Health's website: https://www.fda.gov/​medical-devices/​premarket-submissions/​reduced-medical-device-user-fees-small-business-determination-sbd-program.

For questions relating to this notice: Andrew Bank, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 62019A, Beltsville, MD 20705, 301-796-0292.

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I. Background

Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, supplements, notices, and requests (for simplicity, this document refers to these collectively as “submissions” or “applications”); for periodic reporting on class III devices; and for the registration of certain establishments. Under statutorily defined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee (see 21 U.S.C. 379j(d) and (e)).

Under the FD&C Act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application (a premarket application is a premarket approval application (PMA), a product development protocol (PDP), or a biologics license application (BLA)). The FD&C Act specifies the base fee for a premarket application for each year from FY 2018 through FY 2022; the base fee for a premarket application received by FDA during FY 2022 is $329,000. From this starting point, this document establishes FY 2022 fee rates for certain types of submissions, and for periodic reporting, by applying criteria specified in the FD&C Act.

The FD&C Act specifies the base fee for establishment registration for each year from FY 2018 through FY 2022; the base fee for an establishment registration in FY 2022 is $4,978. There is no reduction in the registration fee for small businesses. Each establishment that is registered (or is required to register) with the Secretary of Health and Human Services under section 510 of the FD&C Act (21 U.S.C. 360) because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device is required to pay the annual fee for establishment registration.

II. Revenue Amount for FY 2022

The total revenue amount for FY 2022 is $213,687,660, as set forth in the statute prior to the inflation adjustment (see 21 U.S.C. 379j(b)(3)). MDUFA directs FDA to use the yearly total revenue amount as a starting point to set the standard fee rates for each fee type. The fee calculations for FY 2022 are described in this document.

Inflation Adjustment

MDUFA specifies that the $213,687,660 is to be adjusted for inflation increases for FY 2022 using two separate adjustments—one for payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)). The base inflation adjustment for FY 2022 is the sum of one plus the two separate adjustments and is compounded as specified in the statute (see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).

The component of the inflation adjustment for payroll costs is the average annual percent change in the cost of all personnel compensation and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60 percent (see 21 U.S.C. 379j(c)(2)(C)).

Table 1 summarizes the actual cost and FTE data for the specified FYs, and provides the percent change from the previous FY and the average percent change over the first 3 of the 4 FYs preceding FY 2022. The 3-year average is 2.7383 percent (rounded).Start Printed Page 41478

Table 1—FDA PC&Bs Each Year and Percent Change

Fiscal year2018201920203-Year average
Total PC&B$2,690,678,000$2,620,052,000$2,875,592,000
Total FTE17,02317,14417,535
PC&B per FTE$158,061$152,826$163,992
Percent change from previous year4.2206%−3.3120%7.3063%2.7383%

The payroll adjustment is 2.7383 percent multiplied by 60 percent, or 1.6430 percent. The statute specifies that the component of the inflation adjustment for non-payroll costs for FY 2022 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All Items; Annual Index) for the first 3 of the preceding 4 years of available data multiplied by 0.40, or 40 percent (see 21 U.S.C. 379j(c)(2)(C)). As a result of a geographical revision made by the Bureau of Labor and Statistics in January 2018,[1] the “Washington-Baltimore, DC-MD-VA-WV” index was discontinued and replaced with two separate indices (i.e., “Washington-Arlington-Alexandria, DC-VA-MD-WV” and “Baltimore-Columbia-Towson, MD”). In order to continue applying a CPI that best reflects the geographic region in which FDA is headquartered and that provides the most current data available, the Washington-Arlington-Alexandria index has been used since FY 2020 and will be used in calculating the relevant adjustment factors for FY 2022 and subsequent years.

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Table 2 provides the summary data and the 3-year average percent change in the specified CPI for the Washington-Arlington-Alexandria area. These data are published by the Bureau of Labor Statistics and can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/​pdq/​SurveyOutputServlet?​data_​tool=​dropmap&​series_​id=​CUURS35ASA0,CUUSS35ASA0.

Table 2—Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI

Fiscal year2018201920203-Year average
Annual CPI261.445264.777267.157
Annual Percent Change2.0389%1.2745%0.8989%
3-Year Average Percent Change in CPI1.4041%

The non-payroll adjustment is 1.4041 percent multiplied by 40 percent, or 0.5616 percent. Next, the payroll adjustment (1.6430 percent or 0.016430) is added to the non-payroll adjustment (0.5616 percent or .005616), for a total of 2.2046 percent (or 0.022046). To complete the inflation adjustment, 1 (100 percent or 1.0) is added for a total base inflation adjustment of 1.022046 for FY 2022.

MDUFA IV provides for this inflation adjustment to be compounded for FY 2022 and each subsequent fiscal year (see 21 U.S.C. 379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for FY 2022, the FY 2021 compounded adjustment (1.114808) is multiplied by the FY 2022 base inflation adjustment (1.022046) to reach the applicable inflation adjustment of 1.139385 (rounded) for FY 2022. We then multiply the total revenue amount for FY 2022 ($213,687,660) by 1.139385, yielding an inflation adjusted total revenue amount of $243,473,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2022

Under the FD&C Act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see 21 U.S.C. 379j(a)(2)(A)).

A. Inflation Adjustment

MDUFA specifies that the base fees of $329,000 (premarket application) and $4,978 (establishment registration) are to be adjusted for FY 2022 using the same methodology as that for the total revenue inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)). Multiplying the base fees by the compounded inflation adjustment of 1.139385 yields inflation adjusted base fees of $374,858 (premarket application) and $5,672 (establishment registration).

B. Further Adjustments

After the applicable inflation adjustment to fees is done, FDA may increase, if necessary to achieve the inflation adjusted total revenue amount, the base fee amounts on a uniform proportionate basis (see 21 U.S.C. 379j(c)(2)(D)(ii)). If necessary, after this adjustment, FDA may further increase the base establishment registration fees to generate the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

C. Calculation of Fee Rates

Table 3 provides the last 3 years of fee-paying submission counts and the 3-year average. These numbers are used to project the fee-paying submission counts that FDA will receive in FY 2022.

Table 3—Three-Year Average of Fee-Paying Submissions

Application typeFY 2018 actualFY 2019 actualFY 2020 actual3-Year average
Full Fee Applications38323033
Small Business7867
Panel-Track Supplement23142220
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Small Business5465
De Novo Classification Request27121117
Small Business29371828
180-Day Supplements133124126128
Small Business27232124
Real-Time Supplements169213175186
Small Business34432935
510(k)s2,1222,0692,0492,080
Small Business1,3851,5581,6671,537
30-Day Notice1,058925867950
Small Business98111105105
513(g) (21 U.S.C. 360c(g)) Request for Classification Information84759685
Small Business33545748
Annual Fee for Periodic Reporting624629420558
Small Business 274966879
Establishment Registration27,54427,73441,40932,229

The information in table 3 is necessary to estimate the amount of revenue that will be collected based on the fee amounts. Table 4 displays the FY 2022 base fees set in statute (column one) and the inflation adjusted base fees (per calculations in section III.A.) (column two). Using the inflation adjusted fees and the 3-year averages of fee-paying submissions, collections are projected to total $262,694,460, which is $19,221,460 higher than the inflation adjusted total revenue amount (in section II). The fees in column two are those we are establishing in FY 2022, which are the standard fees.

Table 4—Fees Needed To Achieve New FY 2022 Revenue Target

Application typeFY 2022 statutory fees (base fees)FY 2022 Inflation adjusted statutory base fees (standard fees)3-Year average of fee-paying submissionsFY 2022 revenue from adjusted fees
Full Fee Applications$329,000$374,85833$12,370,303
Small Business82,25093,7147656,001
Panel-Track Supplement246,750281,143205,622,865
Small Business61,68870,2865351,429
De Novo Classification Request98,700112,457171,911,774
Small Business24,67528,11428787,201
180-Day Supplements49,35056,2291287,197,267
Small Business12,33814,05724337,372
Real-Time Supplements23,03026,2401864,880,647
Small Business5,7586,56035229,600
510(k)s11,18612,7452,08026,509,934
Small Business2,7973,1861,5374,897,328
30-Day Notice5,2645,9989505,697,837
Small Business2,6322,999105314,880
513(g) Request for Classification Information4,4425,06185430,149
Small Business2,2212,53048121,454
Annual Fee for Periodic Reporting11,51513,1205587,320,970
Small Business2,8793,28079259,120
Establishment Registration4,9785,67232,229182,798,329
Total262,694,460

The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $374,858 for FY 2022. The fees set by reference to the standard fee for a premarket application are:

  • For a panel-track supplement, 75 percent of the standard fee;
  • For a de novo classification request, 30 percent of the standard fee;
  • For a 180-day supplement, 15 percent of the standard fee;
  • For a real-time supplement, 7 percent of the standard fee;
  • For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee;
  • For a 510(k) premarket notification, 3.4 percent of the standard fee;
  • For a 30-day notice, 1.6 percent of the standard fee; and
  • For a 513(g) request for classification information, 1.35 percent of the standard fee.

For all submissions other than a 30-day notice and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C) and (e)(2)(C)). For a 30-day notice and a 513(g) request for classification information, the small business fee is 50 Start Printed Page 41480percent of the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)).

The annual fee for establishment registration, after adjustment, is set at $5,672 for FY 2022. There is no small business rate for the annual establishment registration fee; all establishments pay the same fee.

Table 5 summarizes the FY 2022 rates for all medical device fees.

Table 5—Medical Device Fees for FY 2022

Application fee typeStandard fee (as a percent of the standard fee for a premarket application)FY 2022 standard feeFY 2022 small business fee
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))Base fee specified in statute$374,858$93,714
Premarket report (submitted under section 515(c)(2) of the FD&C Act)100374,85893,714
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)100374,85893,714
Panel-track supplement75281,14370,286
De novo classification request30112,45728,114
180-day supplement1556,22914,057
Real-time supplement726,2406,560
510(k) premarket notification submission3.4012,7453,186
30-day notice1.605,9982,999
513(g) request for classification information1.355,0612,530
Annual Fee Type
Annual fee for periodic reporting on a class III device3.5013,1203,280
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14))Base fee specified in statute5,6725,672

IV. How To Qualify as a Small Business for Purposes of Medical Device Fees

If your business, including your affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year, you may qualify for reduced small business fees. If your business, including your affiliates, has gross sales or receipts of no more than $30 million, you may also qualify for a waiver of the fee for your first premarket application (i.e. PMA, PDP, or BLA) or premarket report. If you want to pay the small business fee rate for a submission or you want to receive a waiver of the fee for your first premarket application or premarket report, you should submit the materials showing you qualify as a small business at least 60 days before you send your submission to FDA. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2022, you should not submit a Small Business Certification Request. FDA will review your information and determine whether you qualify as a small business eligible for the reduced fee and/or fee waiver. If you make a submission before FDA finds that you qualify as a small business, you must pay the standard (full) fee for that submission.

If your business qualified as a small business for FY 2021, your status as a small business will expire at the close of business on September 30, 2021. You must re-qualify for FY 2022 in order to pay small business fees during FY 2022.

A. Domestic (U.S.) Businesses

If you are a domestic (U.S.) business and wish to qualify as a small business for FY 2022, submit the following to FDA:

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1. A completed MDUFA Small Business Certification Request For a Business Headquartered in the United States (Form FDA 3602). Form FDA 3602 is provided in the FDA Forms database: https://www.fda.gov/​downloads/​AboutFDA/​ReportsManualsForms/​Forms/​UCM573420.pdf.

2. A signed copy of your Federal (U.S.) Income Tax Return for the most recent tax year. The most recent tax year will be 2021, except:

If you submit your MDUFA Small Business Certification Request for FY 2022 before April 15, 2022, and you have not yet filed your return for 2021, you may use tax year 2020.

If you submit your MDUFA Small Business Certification Request for FY 2022 on or after April 15, 2022, and have not yet filed your 2021 return because you obtained an extension, you may submit your most recent return filed prior to the extension.

3. For each of your affiliates, either:

  • If the affiliate is a domestic (U.S.) business, a signed copy of the affiliate's Federal (U.S.) Income Tax Return for the most recent tax year, or
  • If the affiliate is a foreign business and cannot submit a Federal (U.S.) Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates of the gross receipts or sales collected. The business must also submit a statement signed by the head of the business's firm or by its chief financial officer that the business has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.

B. Foreign Businesses

If you are a foreign business, and wish to qualify as a small business for FY 2022, submit the following:

1. A completed MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States (Form FDA 3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/​downloads/​AboutFDA/​ReportsManualsForms/​Forms/​UCM573423.pdf. Start Printed Page 41481

2. A National Taxing Authority Certification, completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates of the gross receipts or sales collected.

3. For each of your affiliates, either:

  • If the affiliate is a domestic (U.S.) business, a signed copy of the affiliate's Federal (U.S.) Income Tax Return for the most recent tax year (2021 or later), or
  • If the affiliate is a foreign business and cannot submit a Federal (U.S.) Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates for the gross receipts or sales collected. The business must also submit a statement signed by the head of the business's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.

V. Procedures for Paying Application Fees

If your application or submission is subject to a fee and your payment is received by FDA between October 1, 2021, and September 30, 2022, you must pay the fee in effect for FY 2022. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The later of the date that the application is received in the reviewing center's document room or the date the U.S. Treasury recognizes the payment determines whether the fee rates for FY 2021 or FY 2022 apply. FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.

FDA requests that you follow the steps below before submitting a medical device application subject to a fee to ensure that FDA links the fee with the correct application. (Note: Do not send your user fee check to FDA with the application.)

A. Secure a Payment Identification Number (PIN) and Medical Device User Fee Cover Sheet From FDA Before Submitting Either the Application or the Payment

Log into the User Fee System at: https://userfees.fda.gov/​OA_​HTML/​mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet. Be sure you choose the correct application submission date range. (Two choices will be offered until October 1, 2021. One choice is for applications and fees that will be received on or before September 30, 2021, which are subject to FY 2021 fee rates. A second choice is for applications and fees received on or after October 1, 2021, which are subject to FY 2022 fee rates.) After completing data entry, print a copy of the Medical Device User Fee cover sheet and note the unique PIN located in the upper right-hand corner of the printed cover sheet.

B. Electronically Transmit a Copy of the Printed Cover Sheet With the PIN

When you are satisfied that the data on the cover sheet is accurate, electronically transmit that data to FDA according to instructions on the screen. Applicants are required to set up a user account and password to assure data security in the creation and electronic submission of cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a web-based payment system, for online electronic payment. You may make a payment via electronic check or credit card after submitting your cover sheet. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/​pay. Note: only full payments are accepted. No partial payments can be made online. Once you search for your invoice, select “Pay Now” to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards.

2. If paying with a paper check:

  • All paper checks must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. If needed, FDA's tax identification number is 53-0196965.
  • Please write your application's unique PIN (from the upper right-hand corner of your completed Medical Device User Fee cover sheet) on your check.
  • Mail the paper check and a copy of the completed cover sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. (Please note that this address is for payments of application and annual report fees only and is not to be used for payment of annual establishment registration fees.)

If you prefer to send a check by a courier, the courier may deliver the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery contact U.S. Bank at 314-418-4013. This telephone number is only for questions about courier delivery.)

3. If paying with a wire transfer:

  • Please include your application's unique PIN (from the upper right-hand corner of your completed Medical Device User Fee cover sheet) in your wire transfer. Without the PIN, your payment may not be applied to your cover sheet and review of your application may be delayed.
  • The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee it is required that you add that amount to the payment to ensure that the invoice is paid in full.

Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

FDA records the official application receipt date as the later of the following: (1) The date the application was received by the FDA Document Control Center for the reviewing Center or (2) the date the U.S. Treasury recognizes the payment. It is helpful if the fee arrives at the bank at least 1 day before the application arrives at FDA.

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D. Submit Your Application to FDA With a Copy of the Completed Medical Device User Fee Cover Sheet

Please submit your application and a copy of the completed Medical Device User Fee cover sheet to the address located at https://www.fda.gov/​cdrhsubmissionaddress. Start Printed Page 41482

VI. Procedures for Paying the Annual Fee for Periodic Reporting

You will be invoiced at the end of the quarter in which your PMA Periodic Report is due. Invoices will be sent based on the details included on your PMA file. You are responsible for ensuring FDA has your current billing information, and you may update your contact information for the PMA by submitting an amendment to the pending PMA or a supplement to the approved PMA.

1. The preferred payment method is online using electronic check (ACH also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/​pay (Note: only full payments are accepted. No partial payments can be made online). Once you search for your invoice, select “Pay Now” to be redirected to Pay.gov. Note that electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

2. If paying with a paper check:

The check must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. If needed, FDA's tax identification number is 53-0196965.

  • Please write your invoice number on the check.
  • Mail the paper check and a copy of the invoice to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. (Please note that this address is for payments of application and annual report fees only and is not to be used for payment of annual establishment registration fees.)

To send a check by a courier, the courier must deliver the check and printed copy of the cover sheet to: U.S. Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 314-418-4013. This telephone number is only for questions about courier delivery).

3. When paying by a wire transfer, it is required that the invoice number is included; without the invoice number the payment may not be applied. If the payment amount is not applied, the invoice amount would be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full.

Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

VII. Procedures for Paying Annual Establishment Registration Fees

To pay the annual establishment registration fee, firms must access the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/​OA_​HTML/​furls.jsp. (FDA has verified the website address, but FDA is not responsible for any subsequent changes to the website address after this document publishes in the Federal Register.) Create a DFUF order and you will be issued a PIN when you place your order. After payment has been processed, you will be issued a payment confirmation number (PCN). You will not be able to register your establishment if you do not have a PIN and a PCN. An establishment required to pay an annual establishment registration fee is not legally registered in FY 2022 until it has completed the steps below to register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).

Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration (BER) system. FDA's Center for Biologics Evaluation and Research (CBER) will send establishment registration fee invoices annually to these companies.

A. Submit a DFUF Order With a PIN From FDA Before Registering or Submitting Payment

To submit a DFUF Order, you must create or have previously created a user account and password for the user fee website listed previously in this section. After creating a user name and password, log into the Establishment Registration User Fee FY 2022 store. Complete the DFUF order by entering the number of establishments you are registering that require payment. When you are satisfied that the information in the order is accurate, electronically transmit that data to FDA according to instructions on the screen. Print a copy of the final DFUF order and note the unique PIN located in the upper right-hand corner of the printed order.

B. Pay for Your DFUF Order

Unless paying by U.S. credit card, all payments must be in U. S. currency and drawn on a U.S. bank.

1. If paying by credit card or electronic check (ACH or eCheck):

The DFUF order will include payment information, including details on how you can pay online using a credit card or electronic check. Follow the instructions provided to make an electronic payment.

2. If paying with a paper check:

The check must be in U.S. currency and drawn on a U.S. bank, and mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. (Note: This address is different from the address for payments of application and annual report fees and is to be used only for payment of annual establishment registration fees.)

If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 314-418-4013. This telephone number is only for questions about courier delivery.)

Please make sure that both of the following are written on your check: (1) The FDA post office box number (P.O. Box 979108) and (2) the PIN that is printed on your order. Include a copy of your printed order when you mail your check.

3. If paying with a wire transfer:

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Wire transfers may also be used to pay annual establishment registration fees. To send a wire transfer, please read and comply with the following information:

Include your order's unique PIN (in the upper right-hand corner of your completed DFUF order) in your wire transfer. Without the PIN, your payment may not be applied to your facility and your registration may be delayed.

The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-0196965.Start Printed Page 41483

C. Complete the Information Online To Update Your Establishment's Annual Registration for FY 2022, or To Register a New Establishment for FY 2022

Go to the Center for Devices and Radiological Health's website at https://www.fda.gov/​medical-devices/​how-study-and-market-your-device/​device-registration-and-listing and click the “Access Electronic Registration” link on the left side of the page. This opens up a new page with important information about the FDA Unified Registration and Listing System (FURLS). After reading this information, click on the “Access Electronic Registration” link in the middle of the page. This link takes you to an FDA Industry Systems page with tutorials that demonstrate how to create a new FURLS user account, if your establishment did not create an account in FY 2021. Manufacturers of licensed biologics should register in the BER system at https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-establishment-registration.

Enter your existing account ID and password to log into FURLS. From the FURLS/FDA Industry Systems menu, click on the Device Registration and Listing Module (DRLM) of FURLS button. New establishments will need to register and existing establishments will update their annual registration using choices on the DRLM menu. When you choose to register or update your annual registration, the system will prompt you through the entry of information about your establishment and your devices. If you have any problems with this process, email: reglist@cdrh.fda.gov or call 301-796-7400 for assistance. (Note: This email address and this telephone number are for assistance with establishment registration only; they are not to be used for questions related to other aspects of medical device user fees.) Problems with the BER system should be directed to https://www.accessdata.fda.gov/​scripts/​email/​cber/​bldregcontact.cfm or call 240-402-8360.

D. Enter Your DFUF Order PIN and PCN

After completing your annual or initial registration and device listing, you will be prompted to enter your DFUF order PIN and PCN, when applicable. This process does not apply to establishments engaged only in the manufacture, preparation, propagation, compounding, or processing of licensed biologic devices. CBER will send invoices for payment of the establishment registration fee to such establishments.

Start Signature

Dated: July 28, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

1.  The Bureau of Labor Statistics' Announcement of the geographical revision can be viewed at https://www.bls.gov/​cpi/​additional-resources/​geographic-revision-2018.htm.

Back to Citation

[FR Doc. 2021-16408 Filed 7-30-21; 8:45 am]

BILLING CODE 4164-01-P

(Video) FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics

FAQs

What is medical device User Fee Amendments? ›

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

How much does it cost to submit a 510 K? ›

The overall cost to get FDA approval for a 510(K) notification ranges between $30,000 and $44,000 USD. This includes the preparation of the submission and all associated FDA costs.

How are FDA user fees paid? ›

Mailing in a Paper Check
  1. Funds must be in U.S. currency.
  2. Check made payable to Food and Drug Administration (must be in U.S. dollars and drawn on a U.S. Bank)
  3. Write the FDA post office box number ( PO Box 70961) on the check.
  4. Write the Payment Identification Number (PIN) on your check.
23 Dec 2017

What are user charges in healthcare? ›

These charges were levied on out-patient consultation, hospital admission, laboratory tests and other services such as medico-legal services. Preventive services such as vaccination and medicines dispensed were not charged. As per policy, below poverty line patients were exempted from the user charges.

Why does the FDA have user fees? ›

“The user fee programs are intended to supplement FDA's congressionally appropriated resources to speed the review of medical products and get treatments to patients as quickly as possible.

What is a user fee policy? ›

Accountability Office (GAO) defines a user fee as a “fee assessed to users for goods or services provided by the federal. government. User fees generally apply to federal programs or activities that provide special benefits to identifiable recipients above and beyond what is normally available to the public.”

What is a user fee system? ›

A user fee is a charge imposed by the government for the primary purpose of covering the cost of providing a service, directly raising funds from the people who benefit from the particular public good or service being provided.

How much does FDA approval cost for medical device? ›

The FDA medical device user fee for 2022 is $5,672. However, there are other application fees medical device manufacturers should be aware of when they're working on their budgets.

What is the 510 K loophole? ›

Over the years, several myths have been spread about the 510(k) process which have no basis in reality. Myth: The 510(k) program is a “loophole” or “rubber stamp” that provides companies a quick and easy way to get their products onto the market without adequate FDA review.

What does the K mean in 510k? ›

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

Do Class I medical devices need a 510 K? ›

Most Class I and Class II devices are exempt from premarket notification [510(k)] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the Quality System (QS) Regulation.

How much is PDUFA fee? ›

FDA FY2021 user fee table
FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)FY2021Change
Annual establishment registration fee$5,546 ($5,546)$310 ($310)
Outsourcing Facility FeesFY2021Change
Qualified small business establishment fee$5,695$96
42 more rows

What is a Prescription Drug User Fee Act date? ›

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products.

How much are fines from the FDA? ›

Criminal Fines for Food Drug and Cosmetic Act Violations

The following fines are applicable for each offense: Up to $100,000 for a misdemeanor by an individual that does not result in death. Up to $200,000 for a misdemeanor by a corporation that does not result in death.

What are user charges examples? ›

A user fee is a sum of money paid as a necessary condition to gain access to a particular service or facility. Examples of user fees could include highway tolls or parking garages. People pay user fees for the use of many government-affiliated services and facilities as well.

How do you calculate cost per patient? ›

If you don't know how to calculate cost per patient visit, here's how to calculate it. Take your monthly overhead expense (excluding any personal expenses you run through your company such as car payments, etc.) and divide it by the number of office visits you see in a month.

What is a usage fee? ›

Usage Fee means the fee paid to the Performer for the use of the performance in material to advertise the product, service or cause, for the specified usage period.

Does the FDA regulate pricing? ›

We understand that high drug prices have a direct impact on patients—too many American patients are priced out of the medicines they need. However, the FDA has no legal authority to investigate or control the prices set by manufacturers, distributors and retailers.

Does FDA approval cost money? ›

Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

Is a user fee a one time payment? ›

Taxpayers are charged a one-time fee to set up an installment agreement with the IRS. A reduced fee is available for qualifying taxpayers. Generally, user fees are $105 for non-direct debit agreements, $52 for direct debit agreements and $45 for reinstatements.

What is the difference between a user fee and a tax? ›

Fees provide incentives for government-‐provided goods and services within a monetary limit. User fees are not deductible on federal income taxes, whereas property and income taxes are. Taxpayers who itemize their federal income taxes will pay more in federal taxes if user fees are used to replace taxes.

What is end user fee? ›

End User Fee means, the gross amount invoiced to the Customer in connection with the Products less any sales or use taxes, tariffs, custom duties and other government charges, shipping/mailing charges, insurance and returns. End User Fee shall have the meaning set forth in Section 3.5.

What is a basic daily fee? ›

Basic daily fee: An amount that everyone pays for the day-to-day services they will receive at the aged care home. Means tested care fee: A contribution that some people pay toward the cost of their care, determined by a means assessment.

How much is a nominal fee? ›

A nominal fee is below the price of the service provided or presumably easy for a consumer to afford, or a fee that is small enough that it does not have any meaningful impact on one's finances. Nominal may also refer to a rate that's been unadjusted for inflation.

What is a fee range? ›

Range of fees means a statement of fees containing an upper and lower limit on the fees charged for services or goods offered by a social worker.

How much does a medical device patent cost? ›

The filing fee is $130 for a small entity and drawings typically cost $100 to $125 per page, so a high quality provisional patent application for a mechanical or electrical device can typically be prepared and filed for $2,500 to $3,000.

What is FDA fiscal year? ›

FDA Fiscal Year means a twelve (12) month period, commencing on October 1 and ending on September 30.

Who pays for FDA approval? ›

Excluding tobacco user fees, federal budget authorization funds about 61 percent of FDA's budget. The remaining 39 percent is paid for by industry user fees.

What is the difference between 510k and PMA? ›

510k vs PMA Applications: The Main Differences

510k submissions for Class II medical devices and PMA for Class III devices use different regulatory processes. In a nutshell, since Class III devices are crucial for patients' health and life, the FDA applies far stricter regulations to this type of medical device.

What is the difference between 510k and FDA approval? ›

The 510(k) clearance process doesn't require companies to provide safety or effectiveness data from clinical trials. But the FDA still evaluates the device's safety and effectiveness by comparing it to other devices.

Does 510k require clinical data? ›

The two main avenues for the FDA to allow medical devices to be marketed in the U.S. are known as Premarket Approval (PMA), which requires clinical and laboratory studies and a detailed process to determine safety and effectiveness. On the other hand, 510(k) does not require any of that.

Does 510 K expire? ›

Your 510(k) clearance will not expire and is valid until you make changes to the intended use, alter the indications for use, or change technological characteristics.

What should a 510 K include? ›

A 510(k) submission must include a description of the medical device, including all models and accessories or components, as well as device performance specifications. In addition, it is advisable to include information on the materials used in all device components that come in direct contact with patients.

How many types of 510 K are there? ›

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated.

Can Class III devices go through 510k? ›

Premarket Review Process

* Nonexempt devices must be cleared through the 510(k) process rather than the PMA process. III Implantable pacemakers, atrial defibrillators In most cases, premarket approval is required. In limited circumstances, FDA clears Class III devices through the 510(k) process.

What is the difference between a Class 1 and Class 2 medical device? ›

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What are Class A and Class B medical devices? ›

Class A and Class B devices are considered as low risk and moderate risk devices. The application for manufacturing medical devices falling under these classes has to be filed with the State Licensing Authority. Whereas, Class C and Class D devices are classified as High and Very High Risk devices.

Is PDUFA same as FDA approval? ›

Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date.

What is PDUFA and Gdufa? ›

Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II)

What is the difference between an NDA and BLA? ›

To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs.

What are the prescription charges 2022? ›

NHS prescription charges to remain at £9.35 per item for 2022/23 - PSNC Website.

What is a dispensing fee limit? ›

1) Dispensing Fee Cap—This is the maximum amount that a public drug plan will reimburse a pharmacist to dispense a prescription.

What is the maximum cost of a 30 day supply of Tier 4 drugs? ›

You're prescribed a Tier 4(specialty) drug by your Doctor. A 30 day supply costs $1,200. You will pay the $500 Rx deductible and the $500 maximum per script totaling $1,000. The carrier will be billed the remaining $200.
...
2020 Covered California Bronze 60 Rx Benefits.
You pay…
Tier 4 (specialty) Rx Copayfull price up to $500 per script after Rx deductible
5 more rows

What has Pfizer been fined for? ›

Individual Penalty Records:
CompanyPrimary Offense TypePenalty Amount
Pfizerconsumer protection violation$137,174
HOSPIRA, INC.workplace safety or health violation$132,300
Pfizerconsumer protection violation$124,527
PHARMACIA CORPORATION, et al.environmental violation$96,000
76 more rows

How much did Pfizer pay the FDA? ›

Pfizer to Pay $2.3 Billion for Fraudulent Marketing. WASHINGTON – American pharmaceutical giant Pfizer Inc.

Why did Pfizer get fined? ›

— -- In the largest health care fraud settlement in history, pharmaceutical giant Pfizer must pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra, the U.S. Department of Justice announced Wednesday.

Is it free to register with FDA? ›

FDA does not charge any fees for drug facility registration and its free . FDA also does not offer the certificate of registration, companies can verify the successful registration on FDA website. Understand more about establishment registration.

How much is Pdufa fee? ›

FDA FY2021 user fee table
FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)FY2021Change
Annual establishment registration fee$5,546 ($5,546)$310 ($310)
Outsourcing Facility FeesFY2021Change
Qualified small business establishment fee$5,695$96
42 more rows

Who is exempt from FDA registration? ›

(2) The exemption in this paragraph (b) is limited to hospitals, clinics, other health care entities, and public health agencies located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act.

Do medical device distributors need to register with FDA? ›

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA.

How long does FDA registration last? ›

Section 415(a)(3) of the FD&C Act, as amended by section 102 of FSMA, requires your facility to renew its registration with FDA every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Videos

1. Committee on Energy and Commerce Markup Session on the Prescription Drug User Fee Agreement (PDUFA)
(Biotechnology Innovation Organization)
2. MDUFA IV: Building a Sustainable Infrastructure
(U.S. Food and Drug Administration)
3. Health Policy Roundup: Background on FDA User Fee Programs
(Alliance for Health Policy)
4. FDA Establishment Registration and Listing for Medical Devices
(Medical Device Academy)
5. Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 3
(U.S. Food and Drug Administration)
6. Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My- June 10, 2019
(U.S. Food and Drug Administration)

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