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U.S. Department of Health and Human Services

Medical Devices

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MDUFMA Frequently Asked Questions

The Medical Device User Fee and Modernization Act of 2002, amending the Federal Food, Drug, and Cosmetic Act, was signed by President Bush on October 26, 2002, and is now law.


  Background

 User Fees

 Third-Party Inspections

 Reprocessed Single-Use Devices

 Postmarket Surveillance

Background


 What is the Medical Device User Fee and Modernization Act of 2002?

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly significant provisions:

  • User fees for premarket reviews. PMAs, PDPs, BLAs, certain supplements, and 510(k)s are now subject to fees. The revenues from these fees, and from additional appropriations for infrastructure, will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. A small business (sales and receipts of $30 million or less) may pay a reduced fee. The payment of a premarket review fee is not related in any way to FDA’s final decision on a submission.
  • Establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions.
  • New regulatory requirements for reprocessed single-use devices, including provisions requiring the submission of additional data on devices now being reprocessed, and a new category of premarket submission, the premarket report.

MDUFMA makes several other significant changes that are less complex or have a narrower scope than the major changes discussed above. FDA will provide additional information on these provisions in the near future:

  • Additional appropriations for postmarket surveillance are authorized. The act authorizes significant additional appropriations to strengthen FDA’s postmarket surveillance of medical devices marketed in the United States. For FDA to actually receive these resources, Congress must pass appropriations acts providing these additional funds to FDA.
  • The existing third-party 510(k) review program is continued through FY 2006.
  • The review of combination products (products that combine elements of devices, drugs, or biologics) will be coordinated by a new office in the Office of the Commissioner.
  • Electronic labeling is authorized for prescription devices intended to be used in health care facilities.
  • FDA may require electronic registration of device establishments, when feasible.
  • The sunset provision applicable to section 513(i)(1)(E) (intended use based upon labeling) is revoked.
  • The law now explicitly provides for modular review of PMAs.
  • New provisions are added concerning devices intended for pediatric use.
  • GAO and NIH are directed to prepare reports concerning breast implants.
  • The manufacturer of a device must be identified on the device itself, with certain exceptions.

 

 How do I obtain additional information on the requirements of the new law?

FDA has not yet completed its implementation plans for MDUFMA, and may not be able to answer all your questions at this time. We do have a variety of materials that will help you gain an understanding of the new law:

The MDUFMA web pages will be updated and expanded periodically, and will provide the latest information and guidance from FDA concerning the new law.

  • The full text of the new law is available in text and pdf formats.
  • FDA has prepared a brief summary that provides additional information on the key provisions of the new law; this summary is available in text and pdf formats.
  • You can review the legislative history of MDUFMA on the Library of Congress THOMAS legislative information web site, (http://thomas.loc.gov). Search for these bills: H.R. 5651 (the bill that was enacted) and H.R. 3580 (a predecessor bill that led to H.R. 5651).
  • The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) can answer basic questions concerning the new law, and help you find guidance documents and other reference materials. The agency is developing procedures for fee collection and qualification to be treated as a small business. When these procedures are completed, we will post them on the MDUFMA website.

If you have a question that is not answered by DSMICA or the available reference materials, send an e-mail message to MDUFMA@cdrh.fda.gov

 

User Fees


 What are the MDUFMA Fee Payment Instructions?
FY 2003 MDUFMA Fee Payment Instructions
For Submissions Made on or after April 1, 2003
Do not send any payment with your application. Your payment must be made through one of these procedures.
 
Normal Payment Procedures Courier / Delivery Service Procedures Wire Transfer Procedures

You should follow the Normal Payment procedures unless you have a business reason to use an alternative procedure.

1. Complete a Medical Device User Fee Cover Sheet. Full instructions are provided at "MDUFMA User Fees Cover Sheet Instructions".

You will receive a unique Payment Identification Number for each User Fee Cover Sheet you prepare.

2. Prepare your payment. You must pay the full amount of your fee in U.S. dollars. You may pay by check, bank draft, or U.S. postal money order. Make your payment payable to “Food and Drug Administration.“ Write your Payment Identification Number in the memo field of your payment.

3.. Mail your payment and your completed Medical Device User Fee Cover Sheet to —

Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733


Important note: FDA will not provide you any confirmation when we receive your payment. We do not have systems in place to provide this service. You must rely on your bank or other financial institution for this information.

You should follow the Courier / Delivery Service procedures only if you will use a courier or delivery service such as Airborne Express, DHL, FedEx, UPS, or U.S. Postal Service Express Mail.

1. Complete a Medical Device User Fee Cover Sheet. Full instructions are provided at "MDUFMA User Fees Cover Sheet Instructions".

You will receive a unique Payment Identification Number for each User Fee Cover Sheet you prepare.

2. Prepare your payment. You must pay the full amount of your fee in U.S. dollars. You may pay by check, bank draft, or U.S. postal money order. Make your payment payable to “Food and Drug Administration.“ Write your Payment Identification Number in the memo field of your payment.

3.. Send your payment and a completed Medical Device User Fee Cover Sheet to —

US Bank
956733
1005 Convention Plaza
St. Louis, MO 63101

This address is for courier delivery only.

Contact US Bank at 314-418-4013 if you have a question about how to send payment by courier or delivery service.

A wire transfer is appropriate if you cannot use the Normal Payment or Courier / Delivery Service procedures.

Important note: FDA has found that wire transfers can delay proper crediting of your payment and may delay the start of your review.

1. Complete a Medical Device User Fee Cover Sheet. Full instructions are provided at "MDUFMA User Fees Cover Sheet Instructions".

You will receive a unique Payment Identification Number for each User Fee Cover Sheet you prepare.

2. Send your payment to:

Account Name:
Food and Drug Administration
Account Number:
152302010631
Routing Number:
081000210

Also include your Payment Identification Number from your Fee Payment Cover Sheet when you send payment by wire transfer.

Contact US Bank at 314-418-4013 if you have a question about how to send payment by wire transfer.

Important note: Your bank or financial institution may assess a fee for sending a wire transfer. You are responsible for paying all wire transfer fees.

  • You must qualify as a Small Business before you submit your application if you want to pay a reduced or waived fee. If you do not qualify as a Small Business before you submit an application, you must pay the full amount of any fee that applies.
  • For most efficient processing, please make your payment at least one day before you submit your application to FDA.
  • Always include a copy of your Fee Payment Cover Sheet as the first page of your application.
  • If your accounting department needs it, FDA's tax identification number is 53-0196965.
  • If you do not follow these instructions, there may be a delay in crediting your payment and your review may be delayed.
  • Your review will not begin until you have paid the full amount due for your application

Revised August 1, 2003

 Why has Congress authorized user fees?

MDUFMA recognizes that “the public health will be served” by providing additional funds to FDA for “the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met.” FDA’s medical device program resources have been reduced in recent years, and there have been indications that review performance has begun to decline. The user fees provided by MDUFMA, and the additional appropriations that go with the new law, will provide significant benefits:

  • Safe and effective medical treatments will reach patients more rapidly.
  • Greater certainty that manufacturers will receive timely, high quality reviews;.
  • Resources to ensure that devices marketed in the United States continue to meet high standards for safety and effectiveness.
 What are the fees?

For fiscal year 2003 (October 1, 2002 through September 30, 2003), the following fees will apply:

 Table 1 FY 2003 Device Review User Fees
(For Applications Received by FDA between
October 1, 2002 and September 30, 2003
Application
Standard Fee
Small Business
Premarket application (PMA, PDP, BLA)
$154,000
$58,520
Premarket report (premarket approval application for a reprocessed device)
$154,000
$58,520
Panel-track supplement
$154,000
$58,520
Efficacy supplement
$154,000
$58,520
180-day supplement
$33,110
$12,582
Real-time supplement
$11,088
$4,213
510(k)
$2,187
$2,187 *

* For FY 2003, all 510(k)s are subject to the standard fee of $2,187. The law provides for a reduced 510(k) fee for a small business in FY 2004 and later years.

Remember:  If FDA receives your application on or after October 1, you must pay the fee that applies for the new fiscal year.  The date you mail or send your application does not matter; the only date that matters is the date FDA actually receives your application.  For example, if you mail your application on September 29, 2003 (towards the end of FY 2003) , and FDA receives it on October 1, 2003 (the first day of FY 2004), you must pay the fee that applies for FY 2004.  FDA is not responsible for delays in the delivery of your application.

For fiscal year 2004 (October 1, 2003 through September 30, 2004), the following fees will apply:

FY 2004 Device Review User Fees
(For Applications Received by FDA between
October 1, 2003 and September 30, 2004

Application

Standard Fee

Small Business

Premarket application (PMA, PDP, BLA)

$206,811

$78,588

Premarket report (premarket approval application for a reprocessed device)

$206,811

$78,588

Panel-track supplement

$206,811

$78,588

Efficacy supplement

$206,811

$78,588

180-day supplement

$44,464

$16,896

Real-time supplement

$14,890

$5,658

510(k)

$3,480

$2,784

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

FDA Questions and Answers on Medical Device User Fee Billing Issues

 When must I pay a fee?

You must pay a fee for each premarket application, premarket report, supplement, or 510(k) you submit, unless your are eligible for a waiver or exception. If you do not pay the appropriate fee, FDA will not file or review your application and you will not be able to market your device.

 Will FDA accept electronic payments?

FDA accepts wire transfers. See our MDUFMA Fee Payment Instructions to learn how to pay by wire transfer.  Your bank or financial institution may assess a fee for sending a wire transfer.  You are responsible for paying all wire transfer fees.

 Are there any fee waivers, exemptions, or reductions?

Fee waivers and exemptions. Under the new law, a fee will not be charged for certain submissions:

Fee Exemptions and Waivers (No Fee for These)
Category Exemption or Waiver
HDE Exempt from any fee.
BLA for a product licensed for further manufacturing use only Exempt from any fee.
First premarket application (PMA, PDP, BLA, or premarket report) from a small business One-time waiver of the fee that would otherwise apply.
Third-party 510(k) Exempt from any FDA fee; however, the third-party may charge a fee for its review.
Any application for a device intended solely for pediatric use. Exempt from any fee. If an applicant obtains an exemption under this provision, and later submits a supplement for adult use, that supplement is subject to the fee then in effect for an original premarket application.
Any application from a State or Federal Government entity. Exempt from any fee unless the device is to be distributed commercially.

Reduced fees are available to protect small businesses. An applicant that qualifies as a small business is eligible for reduced fees. Small business fees are significantly less than the fees that would otherwise be assessed; see Table 1.

 How can a small business qualify for reduced fees?

For FY 2003 and for FY 2004, a small business is one with gross sales or receipts of no more than $30 million, including sales and receipts of all affiliates, partners, and parent firms; FDA may adjust this threshold in future years. An applicant who must pay a fee must pay the standard fee unless it qualifies as a small business. To qualify for reduced fees, a small business must submit Federal income tax forms (for itself, and all affiliates, partners, and parent firms), showing that its sales and receipts do not exceed $30 million. If the $30 million small business threshold is shown to reduce user fee revenues by more than 16%, FDA may adjust the threshold to a lower level.

Your status as a small business expires at the end of the fiscal year.  You must requalify as a small business to be eligible for reduced or waived fees for applications you submit during a later fiscal year.

You must qualify as a small business at least 60 days before your first submission in any fiscal year you want to pay the reduced small business fees.

Each year, as fees are adjusted, small business fees will be set at the following levels:

Determination of Small Business Fees
Application Small Business Fee
  • Premarket application (PMA, PDP, BLA)
  • Premarket report (premarket approval application for a reprocessed device)
  • Panel-track supplement
  • Efficacy supplement
  • 180-day supplement
  • Real-time supplement
38% of standard fee
  • 510(k)
80% of standard fee for FY 2004 and subsequent fiscal years
 What can happen if I do not pay a fee that is due?

If a fee is not paid, the submission “shall be considered incomplete and shall not be accepted for filing” until the fee is paid in full. FDA will not begin its review of a submission until the fee for that submission is paid and all fees for previous submissions have been paid. If a fee is not paid within 30 days after it is due, the fee may be treated as a claim of the U.S. Government.

 Under what circumstances will FDA refund part of a fee that has been paid for a premarket application, premarket report, or supplement?

If you make a written request within 180 days after the fee was due (see § 738(j)), FDA will refund 75% of a paid fee if we refuse to file a submission, or if the applicant withdrew a submission prior to our filing decision. § 738(a)(1)(D)(i) and (ii). If an applicant withdraws a premarket application, premarket report, or supplement after filing, but before a first action1 , FDA may, but is not required to, refund any portion of the fee, based on the level of effort already expended. FDA’s decision to make or refuse a refund after filing, and our determination of the amount of any refund, is not reviewable. § 738(a)(1)(D)(iii). FDA will not refund any portion of a fee following a first action. If an applicant resubmits an application that FDA refused to file, or which the applicant withdrew, a new fee (full amount) must be paid.


1“First action” means major deficiency, not approvable, approvable, approvable pending GMP inspection, or denial.

 How will FDA show that medical device review performance is improving?

The performance goals that FDA will pursue as part of the user fee program include specific year-by-year goals for improvement in device review times, as well as other important goals, such as maintaining performance in areas where specific goals have not been identified, using fee revenues for reviewer training and expanded use of outside consultants and contractors, modular reviews, and improving the timeliness of premarket inspections. The law provides for annual reports by FDA and studies by GAO.

 How soon will FDA show improvement in medical device reviews?

FDA’s performance under the act is to be measured against goals set forth in the commitment letters from Secretary Thompson. These goals recognize that FDA needs to build infrastructure, hire and train new staff, and take other steps to lay the groundwork for success. The goals require significant, measurable improvements by FY 2005, but FDA will strive to show real improvement more quickly.

Sunset date.

FDA’s authority to collect fees under MDUFMA expires October 1, 2007.

In addition, for fiscal years 2006 and 2007, if Congressional appropriations for the device program for that year do not meet certain levels, FDA may not assess medical device user fees for that year and FDA will not be required to meet performance goals for that year.

 

Third-Party Inspections


 Why has Congress authorized third-party establishment inspections?

MDUFMA amends section 704 of the Federal Food, Drug, and Cosmetic Act to authorize FDA-accredited persons to inspect qualified manufacturers of class II and class III devices. These provisions are intended to help FDA focus its limited inspection resources on higher-risk inspections and give medical device firms that operate in global markets an opportunity to more efficiently schedule multiple inspections.

 How much does a third party inspection cost, and who pays for it?

FDA does not set the fees that an accredited person may charge for an inspection, and FDA does not pay for such inspections. The establishment that wishes to use a particular third-party must negotiate the cost with the accredited person and is responsible for paying the negotiated fee.

 Who can be accredited to conduct third-party inspections?

A person who wishes to be accredited by FDA to conduct establishment inspections:

  • may not be an employee of the Federal Government;
  • may not be owned by, or have an “affiliation (including a consultative affiliation)” with a device manufacturer, supplier, or vendor;
  • cannot be engaged in the design, manufacture, promotion, or sale of FDA-regulated products;
  • must operate “in accordance with generally accepted professional and ethical business practices” and must agree in writing to certain fundamental operating principles;
  • may not have a financial conflict of interest regarding any FDA-regulated product.
 Which establishments are eligible for inspection by a third-party?

To employ an accredited person in lieu of an FDA inspection, an establishment must meet certain conditions:

  • the most recent inspection must have been classified as “no action indicated” or “voluntary action indicated.”
  • the establishment must notify FDA of the person it intends to use, and FDA must agree to the selection.
  • the establishment must market a device in the United States and must market a device “in one or more foreign countries.”
  • the accredited person must be certified, accredited, or otherwise recognized by one of the countries in which the device is to be marketed
  • the establishment must submit a statement that one of the countries in which the device is to be marketed “recognizes an inspection of the establishment by [FDA].”
 Are there effective controls to prevent possible conflicts of interest in the third-party inspection program?

MDUFMA includes very stringent provisions designed to avoid conflict of interests. As described above, an accredited person may not be owned by, or have an affiliation with a device manufacturer, supplier, or vendor; cannot serve as a consultant; cannot be engaged in the design, manufacture, promotion, or sale of FDA-regulated products; and cannot have a financial interest in any FDA-regulated product. The new law requires FDA to audit the performance of third-party inspectors and to review the compliance history of each establishment whenever it requests a third-party inspection. There are also severe penalties if an accredited person violates the law, including permanent debarment, civil money penalties, and criminal prosecution.

The law requires FDA to clear an establishment’s choice of an accredited person whenever it wishes to obtain a third-party inspection. The law permits FDA to ask for additional information concerning the establishment’s relationship with the third-party. And the law generally prohibits the use of third-parties for more than two consecutive inspections; this ensures that FDA will have the opportunity to continue to periodically inspect all establishments.
 

 How soon will I be able to obtain a third party inspection?

On April 28, 2003, FDA announced the criteria it will use to accredit persons for the purpose of conducting inspections of eligible device manufacturers under § 704(g)..  See Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties on our MDUFMA Guidance page for additional information.

FDA must accredit third-parties by October 26, 2003; an eligible establishment would then be permitted to select any accredited person to conduct an inspection in lieu of an FDA inspection.

Sunset date.

The authority for third-party establishment inspections expires October 1, 2012.

 

Reprocessed Single-Use Devices


 How will reprocessed single-use devices be regulated under the new law?

Before enactment of the new law, the regulatory requirements for manufacturers of reprocessed single-use devices (the persons who are reprocessing the device) basically depended upon the class of the device. Manufacturers of reprocessed class I and II single-use devices were required to have a 510(k), unless the device was exempt from 510(k). Reprocessors of class III devices were required to obtain premarket approval. Under the new law, reprocessors of some previously-exempt devices will no longer be exempt from the 510(k) submission requirements and will need to submit 510(k)s that include validation data. Validation data will also be required for many reprocessors of single-use devices that are currently the subject of cleared 510(k)s. Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application). More detail is provided below.

 If my reprocessed single-use device was 510(k) exempt before the new law, is it still exempt?

Not necessarily.  FDA reviewed the types of reprocessed single-use devices that were previously exempt from 510(k), and determined which of these exemptions should be terminated. On April 30, 2003, FDA published a Federal Register notice that included a list of critical2 reprocessed single-use devices whose exemption from 510(k) is being terminated and for which validation data is now required in 510(k)s.  For a previously-exempt critical reprocessed single-use device to  remain on the market after July 30, 2004, a 510(k) must be submitted, including “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended”, and FDA clearance must be obtained.  If a 510(k) is not submitted, or if FDA finds the device to be “not substantially equivalent,” marketing of the device must cease.

On June 26, 2003, FDA published a Federal Register notice adding nonelectric biopsy forceps to the list of reprocessed single-use devices whose exemption from premarket notification has been terminated and for which validation data is required.

A reprocessed single-use device not included on this list may continue to be marketed without submission of a 510(k).

By April 26, 2004, FDA is to review the types of semi-critical3 reprocessed single-use devices that are currently exempt from 510(k), and determine which of these exemptions is to be terminated.  FDA must publish a Federal Register notice listing these devices.  510(k)s submitted for these devices must include validation data, and must be submitted within 15 months of publication of the list.  See § 510(o)(2).


2A “critical reprocessed single-use device” is a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
3A “semi-critical reprocessed single-use device” is reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
 

 When will FDA require validation data for reprocessed single-use devices that already require 510(k) clearance (i.e., devices that are not 510(k) exempt)?

On April 30, 2003, FDA published a Federal Register notice that included a list of critical2 reprocessed single-use devices that are already subject to 510(k), but for which the manufacturer must now submit “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended” by the person who submits the 510(k).   For a reprocessed single-use device that obtained 510(k) clearance prior to April 30, 2003, the manufacturer must submit validation data to FDA by January 30, 2004 if the device is to remain on the market.  Any new 510(k) (any 510(k) submitted after April 30, 2003) for a device on this list must include validation data. 

 When will FDA require premarket reports for class III reprocessed single-use devices?

The requirement for submission of premarket reports for class III reprocessed single-use devices went into effect on the act’s effective date, October 26, 2002. Previously, PMAs were required for these devices.

 What labeling changes are required for reprocessed single-use devices and when must the new labeling be used?

Any reprocessed single-use device (i.e., devices exempt from 510(k) requirements, subject to 510(k) requirements, or subject to a premarket report) introduced into interstate commerce after January 25, 2004 must “prominently and conspicuously” bear the statement:

Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device] .

This provision will make it easier for patients and health care professionals to know when they are using a reprocessed device.

 

Postmarket Surveillance


 Does the new law do anything to strengthen postmarket surveillance?

MDUFMA authorizes additional appropriations for postmarket surveillance — $3 million for FY 2003, $6 million for FY 2004, and “such sums as may be necessary” in subsequent years. An authorization for additional appropriations does itself not provide FDA any additional resources. For FDA to receive these resources, Congress would have to pass appropriations acts providing these additional funds to the agency.

In addition, MDUFMA requires FDA to conduct, and submit to Congress by January 10, 2007, a study of:

  • the effect of medical device user fees on FDA’s ability to conduct postmarket surveillance.
  • the extent to which device companies comply with postmarket surveillance requirements.
  • any improvements needed for adequate postmarket surveillance, and the amount of funds needed to do so.
  • recommendations as to whether, and in what amount, user fees should be used for postmarket surveillance, if extended beyond FY 2007.