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Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
II. Internal Review through the Supervisory Chain under 21 C.F.R. § 10.75
III. Recommended Procedures for Resolving Disputes that Affect the Payment or Refund of Medical Device User Fees —
Questions Concerning the Amount of a Fee or Refund
1. Can I negotiate or appeal the amount of a fee FDA wants me to pay or the amount of a refund FDA wants to pay to me?
2. Will FDA review my application while I proceed with an appeal?
Questions Concerning an Applicant’s Status
3. How can I appeal an FDA determination that I am not a small business” under MDUFMA and must pay a full fee rather than a reduced or waived small business” fee?
4. How can I appeal an FDA determination that I am not eligible for a fee waiver for an application submitted by a government entity?
Questions Concerning the Status of an Application
5. How can I appeal an FDA decision to not file” my application?
6. How can I appeal an FDA determination that I must pay a higher fee because my submission is not the type of application I believe it to be?
7. How can I appeal an FDA determination that its review of my application had reached a particular stage when I withdrew the application?
8. How can I appeal an FDA determination that a premarket application I submitted is not my first?
Questions Concerning Review Mechanisms
9. How can I appeal FDA's designation of the primary review process for my combination product?
10. What can I do if FDA does not review and act on my combination product application in a timely manner?
Questions Concerning Intended Use
11. How can I appeal an FDA determination that I cannot "bundle" a device into a single application involving multiple devices? How can I appeal an FDA determination that I cannot "bundle" an indication for use of a device into a single application involving multiple indications for use for that device?
12. How can I appeal an FDA determination that my application is not solely for a pediatric population?
Questions Concerning Refunds
13. I accidentally submitted a duplicate (second) payment for my application. Can I obtain a refund of the extra amount I paid?
14. I paid a fee for review of a 510(k), and FDA determined that my device is exempt from the requirement for a 510(k) premarket notification or I paid a fee for review of a 510(k) or a PMA, and FDA determined that my product is not a device. Can I obtain a refund of the amount I paid?
15. Are there instances where I cannot obtain a refund of any portion of a fee I have paid for review of a medical device application?
16. If FDA determines I should receive a refund, how soon should I expect to receive my refund check?
IV. Sources of Additional Information
17. How can I obtain more information about a particular appeals process?
18. How can I learn more about MDUFMA?
Comments and suggestions may be submitted at any time for Agency consideration to —
Dockets Management Branch (HFA-305)
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville , MD , 20852
When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance, contact —
Sherry Lard, CBER Ombudsman
Center for Biologics Evaluation and Research (HFM-4)
Food and Drug Administration
1401 Rockville Pike
Rockville , MD 20852-1448
Telephone: (301) 827-0379
– or –
Les S. Weinstein, CDRH Ombudsman
Center for Devices and Radiological Health (HFZ- 5)
Food and Drug Administration,
9200 Corporate Blvd.
Rockville , MD 20850
Telephone (301) 827-7991
Additional copies are available from the Internet at: www.fda.gov/cdrh/mdufma/guidance/1303.pdf
Copies are also available from the CDRH Facts-on-Demand system. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1303) followed by the pound symbol (#). Follow the remaining voice prompts to complete your request.
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that the information requested in the guidance is not relevant to the decision-making process or that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH’s Ombudsman, including ways to contact him, can be found on the Internet at —
www.fda.gov/cdrh/resolvingdisputes/ombudsman.html
This guidance provides FDA’s recommendations concerning the most timely and effective way to resolve disputes concerning FDA actions that affect the payment or refund of a user fee assessed under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). In some instances, alternative appeals processes may be available.
Full information on appeals processes used by the Center for Devices and Radiological Health (CDRH) is provided in —
These CDRH guidance documents are available at —
www.fda.gov/cdrh/ombudsman/dispute.html
Full information on appeals processes used by the Center for Biologics Evaluation and Research (CBER) is provided in —
�Note concerning statutory citations . Throughout this document, all statutory citations are to the Federal Food, Drug, and Cosmetic Act except where otherwise noted.
In most instances, FDA believes disputes in the areas covered by this guidance are best resolved through a request for internal review through the supervisory chain under 21 C.F.R. § 10.75. A review through the supervisory chain is an informal process that is usually far more timely than any other review option. For this reason, we are providing an overview of this important process. For additional information, see the regulation itself and the other references cited throughout this guidance.
Most disputes concerning actions that affect the payment or refund of a MDUFMA fee will involve a specific application or submission. The remaining disputes will concern whether an applicant qualifies as a small business or government entity. FDA does not expect such disputes to involve scientific issues. This overview is written from that perspective.
Overview of 21 C.F.R. § 10.75 as it relates to MDUFMA fees . Upon request of the applicant, an FDA decision concerning an application may generally be reviewed by the supervisor of the employee who made the decision. A review under 21 C.F.R. § 10.75 will ordinarily follow the established FDA supervisory or review chain. The review will involve consultation between the supervisor and the employee, or review of the administrative file by the supervisor. The applicant does not participate in the review. In most instances, a review will be completed at a supervisory level below the Center Director or the Office of the Commissioner.
Alternative approaches. In all but the most unusual circumstances, an internal review through the supervisory chain can be requested, granted, and completed in far less time than other dispute resolution processes provided by FDA regulations. Depending on the particular circumstances, alternatives include a citizen petition (21 C.F.R. § 10.30), administrative reconsideration of an action (21 C.F.R. § 10.33), a formal evidentiary public hearing (21 C.F.R. Part 12), a public hearing before a board of inquiry (21 C.F.R. Part 13), a public hearing before a public advisory committee (21 C.F.R. Part 14), a public hearing before the FDA Commissioner (21 C.F.R. Part 15), and a regulatory hearing before the Food and Drug Administration (21 C.F.R. Part 16). See the guidance documents listed in the Background section (p. ) for information on these alternative approaches.
III. Recommended Procedures for Resolving Disputes that Affect the Payment or Refund of Medical Device User Fees
Questions Concerning the Amount of a Fee or Refund
1. Can I negotiate or appeal the amount of a fee FDA wants me to pay or the amount of a refund FDA wants to pay to me?
You cannot appeal the amount of a fee or the amount of a refund. You can appeal the FDA action that requires you to pay a particular fee or that will result in a particular refund.
Fee amounts . The fee amounts FDA assesses under MDUFMA are set by FDA each year. We follow instructions provided by law when we set these fees. We announce updated fees for the next fiscal year by August 2 of each year, and we publish those fees in a Federal Register notice. See sections 738(a)(1)(A) and 738(c). Every applicant who must pay a MDUFMA fee must pay the published fee that applies to any application it submits.
MDUFMA provides several fee exemptions and waivers and provides for lower fees when an applicant has qualified as a small business,” but MDUFMA does not authorize FDA to negotiate the amount of a fee to be paid for a particular application or to waive or reduce a fee simply because the fee would present a financial hardship to a particular applicant. We can provide a fee waiver or reduction only when the law specifically provides us the authority to do so.
Refunds . FDA will not refund any portion of a MDUFMA review fee —
See question 14, p. , for additional information on these restrictions on refunds.
In other circumstances, a refund is possible. MDUFMA specifically provides for a refund if FDA refuses to file your application or if you withdraw your application within time frames set by the law.
The law requires FDA to refund 75% of a fee if we refuse to file your application or you withdraw your application before we make a filing decision. See sections 738(a)(1)(D)(i) and 738(a)(1)(D)(ii).
If you withdraw your application after we make a filing decision but before we take a first action, the law gives FDA sole discretion” to refund some or all” of the fee based on the level of effort already expended on the review.” Section 738(a)(1)(D)(iii). FDA believes that, in most instances, our level of effort can be appropriately assessed by the number of days that an application was under review. We have issued guidance explaining how we generally intend to make a refund in such situations for traditional premarket approval applications (PMAs) and panel-track PMA supplements; see User Fees and Refunds for Premarket Approval Applications, available at
www.fda.gov/cdrh/mdufma/guidance/1224.pdf.
That guidance explains that, unless there are unusual circumstances, we will normally provide such refunds as follows:
| Refund Normally to be Provided when a PMA or Panel-track PMA Supplement is Withdrawn by the Applicant | |
| When Withdrawn (Days from Receipt) | Normal Refund Amount |
|---|---|
| Before filing | 75% |
| After filing to day 90 | 50% |
| Between day 91 and day 135 | 25% |
| After day 135 | No refund |
There may be instances where our level of effort is not adequately reflected by looking at elapsed time alone. If that is the case, we may adjust the amount of your refund to reflect any special circumstances that apply.
If you withdraw your application after we make a filing decision but before we take a first action, FDA’s decision regarding whether to make a refund of any portion of the fee paid for review of that application, and the amount of any such refund, is not reviewable. FDA will not consider any appeal, and you cannot obtain judicial review of FDA’s decision. See section 738(a)(1)(D)(iii). For additional information on FDA first actions,” see question 14.
The law does not permit FDA to negotiate the amount of a refund for a particular application or to increase the amount of the refund to avoid a financial hardship to a particular applicant. The law does not permit FDA to give you a credit” towards a future new application or resubmission of an application.
2. Will FDA review my application while I proceed with an appeal?
No. FDA cannot review your application if you pay less than the entire amount of any fee that applies. This is because the law requires FDA to consider your submission incomplete” and it instructs us that the submission shall not be accepted for filing . . . until all fees owed . . . have been paid.” See section 738(f). If you want FDA to begin a review of your application while you appeal an FDA decision that requires you to pay a fee, you should pay the fee sought by FDA. If your appeal results in a determination that you should have paid a lower fee (or no fee), FDA will refund any excess payment you made.
Appeals Concerning an Applicant’s Status
3. How can I appeal an FDA determination that I am not a small business under MDUFMA and must pay a full fee rather than a reduced or waived small business” fee?
FDA uses information you provide on a Small Business Qualification Certification (Form FDA 3602) to determine whether you are a small business” within the meaning of MDUFMA. This form, instructions, and an explanation of the criteria and process FDA will use to evaluate your information, are provided in an FDA guidance document that is updated each year. For FY 2005, see—
To qualify as a small business for applications you submit during FY 2005, your gross receipts and sales” — including the gross receipts and sales of all of your affiliates, partners, and parent firms — must be no more than $30 million. See sections 738(d)(2)(C) and 738(e)(2)(C). You must submit a completed Small Business Qualification Certification (Form FDA 3602) and copy of your most recent Federal (U.S.) income tax return for a taxable year to show that you qualify as a small business. FDA cannot accept a foreign tax return as a substitute for a Federal (U.S.) income tax return. See sections 738(d)(2)(B) and 738(e)(2)(B).
Each year, FDA will provide updated guidance on the criteria you must meet to qualify as a small business; this may include a revised gross receipts and sales” threshold. We will publish this guidance around the time we publish the Federal Register notice announcing MDUFMA fees for the next fiscal year (around August 2 of each year). The new guidance will be announced on our Internet site at www.fda.gov/cdrh/mdufma.
If FDA determines you are a small business, you will be eligible for reduced or waived MDUFMA user fees. See sections 738(d)(1) and 738(e)(1). If FDA determines you are not a small business, you must pay the full (standard) fee for an application that is subject to a fee.
The fee you must pay for an application is determined and fixed on the date FDA receives your application. If you submit an application before FDA has determined you qualify as a small business, you must pay the standard (full) amount of any fee that applies. FDA will not refund the difference between the standard (full) fee and the small business fee if you later qualify as a small business. If you want to pay the small business fee for an application, do not submit the application until you obtain your Small Business Decision number from FDA.
Examples of issues most likely to be presented on appeal :
Recommended appeals process : You should request an internal review through the supervisory chain under 21 C.F.R. § 10.75. The review would proceed through:
FDA’s final decision regarding whether an entity is a small business is not reviewable . FDA will not consider any subsequent appeal, and you cannot obtain judicial review of FDA’s decision. See sections 738(d)(2)(D) and 738(e)(2)(D).
Recommended time frame for making your appeal: You should make your appeal within 60 days of FDA’s determination that you are not a small business. FDA expects to respond to your appeal within 30 days.
Send your appeal to :
All appeals (both CBER and CDRH appeals) should be sent to:
MDUFMA Appeal
Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220)
Center for Devices and Radiological Health Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850-4307
FDA uses information you provide to determine -
If we determine you are a government entity and you will not
commercially distribute your device, you will not have to pay a MDUFMA user
fee for that application. See section 738(a)(1)(B)(iii). If you do
not meet both criteria, you must pay any fee that applies to your application.
MDUFMA does not define “State or Federal Government entity.” FDA
administers another law, the Prescription Drug User Fee Act (PDUFA) that also
exempts government entities from user fees for drug applications. This guidance
uses the same definition of “State or Federal Government entity”
that FDA is applying under PDUFA. Under this definition, you may qualify as
a government entity by submitting a letter certifying that you meet all
of the following criteria:
Once we have determined you are a governmental entity, you may obtain a waiver
of a MDUFMA fee for a particular application if you certify that you are a government
entity and that you do not intend to commercially distribute the device for
which you are requesting a fee waiver.
You will certify that you meet these requirements each time you submit
an application for which you want a fee waiver. FDA will audit these certifications
to ensure that applicants meet these criteria.
If we determine that you do not qualify as a government entity or if we determine
that you will commercially distribute your device, we will send you a letter
informing you of our determination and summarizing its basis.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: You should request an internal review through the supervisory chain under 21 C.F.R. § 10.75. The review would proceed through:
Recommended time frame for making your appeal: You should
make your appeal within 60 days of FDA’s determination that you are not
a government entity. If FDA has determined that you are a government entity,
but has determined that your device is to be “distributed commercially,”
you should appeal within 60 days of FDA’s determination that your device
will be distributed commercially. FDA expects to respond to your appeal within
30 days.
Send your appeal to:
All appeals (both CBER and CDRH appeals) should be sent to:
MDUFMA Appeal
Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220)
Center for Devices and Radiological Health
Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850-4307
If FDA decides to “not file” your application, we will not review
your application. FDA will refund 75% of the fee you paid (unless you did not
pay the correct amount, in which case, we will adjust your refund). If you resubmit
the application, you must pay the entire fee that applies to the application.
FDA will not give you a “credit” for the portion of the fee that
we retained when we determined we could not file your prior application.
FDA uses the following criteria when making a PMA filing decision:
For BLAs, we apply:
For 510(k)s:
Examples of issues most likely to be presented on appeal:
Recommended appeals processes: FDA has specific appeals processes for resolution of disputes concerning the filing of an application.
www.fda.gov/cdrh/mdufma/guidance/1511.pdf
Because FDA will not provide a refund when a 510(k) is withdrawn, there is no appeals process.
Recommended time frame for making your appeal:
Send your appeal to:
CBER filing appeals: (Send your appeal to the office that refused to file your
application.)
Director, Office of Blood Research and Review, HFM-300
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
or
Director, Office of Cell, Tissue, and Gene Therapies, HFM-700
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH filing appeals:
PMA filing appeals:
Director, Office of Device Evaluation (HFZ-400)
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
If FDA determines —
then FDA will not accept your application until you pay the higher fee. This
is because under the law your submission “shall be considered incomplete
and shall not be accepted . . . until all fees owed . . . have been paid.”
See section 738(f).
In such instances, we will fax or mail you a letter (usually within one day)
explaining that FDA will not file your submission unless you pay the appropriate
fee within 30 days. If you do not pay the appropriate fee within 30 days, FDA
will send you a letter explaining that the submission was not accepted, that
FDA did not review the submission, and that the device may not be marketed until
your obtain FDA clearance or approval. We will also refund any payment you made
for review of the submission.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the
supervisory chain under 21 C.F.R. § 10.75
If FDA determined your application is to be reviewed by CDRH and is a PMA, a
panel-track PMA supplement, a180-day PMA supplement, or a real-time supplement,
your appeal through the supervisory chain would proceed through:
If FDA determines your application is to be reviewed by CBER and is a PMA,
a panel-track supplement, a 180-day supplement, a real-time supplement, a BLA,
or a BLA efficacy supplement, your appeal will follow the process described
by SOPP 8005, Major Dispute Resolution Process (February 1999).
Recommended time frame for making your appeal: You should
make your appeal within 30 days of FDA’s decision that your application
is a type of application that requires a higher fee than you paid. (Note: FDA
will delete your application 30 days after we inform you of our decision that
we cannot review it unless you pay the higher fee we have determined is due;
if we delete your application, we will refund the full amount you paid for review
of that submission.) FDA expects to respond to your appeal within 30 days.
Send your appeal to:
CBER appeals: (Send your appeal to the office that would review your application.)
Director, Office of Blood Research and Review (HFM-300)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
or
Director, Office of Cell, Tissue, and Gene Therapies (HFM-700)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH appeals:
Director, Program Operations Staff (HFZ-402)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
The stage at which a review is terminated when you withdraw an application determines the amount of the fee FDA will refund:
If you want a refund when you withdraw your application, you must make a “written request” for a refund “not later than 180 days after such fee is due.” Section 738(j). All fees are due at the time the application is filed or accepted. See section 738(f). This means your request for a refund must be made within 180 days of the date FDA filed or accepted your application. If you do not request a refund when you withdraw your application, or you delay too long in making your request, FDA will not provide any refund.
The law does not authorize any refund of a 510(k) fee after FDA files the application. See section 738(a)(1)(D)(iii). Also, FDA has determined that we will not provide any refund —
FDA considers your 180-day or real-time PMA supplement to be filed as soon
as we have received your supplement and you have paid the fee
due for the review. Under section 738(a)(1)(D)(iii), after FDA has filed an
application, we are to base any refund on the level of effort we expended. Because
the fees for these supplements are much lower than the fee for an original premarket
application and because these reviews are conducted under a shorter period of
time, we have determined that the level of effort required to review these supplements
is so significant that any refund would be unwarranted.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the supervisory
chain pursuant to 21 C.F.R. § 10.75.
Appeals through the CDRH supervisory chain would proceed through:
Appeals through the CBER supervisory chain will follow the process described by SOPP 8005, Major Dispute Resolution Process (February 1999), and would proceed through:
If FDA has filed your application, but has not yet taken a first action, FDA
has “sole discretion” to refund “some or all” of the
fee you paid “based on the level of effort already expended on the review.”
Section 738(a)(1)(D)(iii). In most instances, FDA believes our level of effort
can be appropriately estimated by determining how much time has elapsed since
we filed the application. There may be instances where our level of effort is
not adequately reflected by looking at elapsed time alone, and our refund will
reflect any special circumstances that apply. We will normally provide refunds
as follows:
| Refund Normally to be Provided when a PMA or Panel-track PMA Supplement is Withdrawn by the Applicant | |
| When Withdrawn (Days from Receipt) |
Normal Refund Amount |
|---|---|
| Before filing | 75% |
| After filing to day 90 | 50% |
| Between day 91 and day 135 | 25% |
| After day 135 | No refund |
See question 1 for additional information.
Whenever an application is withdrawn after filing but before
a first action, FDA’s decision regarding whether to make a refund
of any portion of the fee paid for review of that application, and the amount
of any such refund, is not reviewable. FDA will not consider any
appeal, and you cannot obtain judicial review of FDA’s decision. See section
738(a)(1)(D)(iii).
FDA has no authority to make any refund after we have taken a first action.
See section 738(a)(1)(D).
Recommended time frame for making your appeal: You should make
your appeal within 60 days of FDA’s refund decision. FDA expects to respond
to your appeal within 30 days.
Send your appeal to:
CBER appeals: (Send your appeal to the office that was reviewing your application.)
Director, Office of Blood Research and Review, HFM-300
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448or
Director, Office of Cell, Tissue, and Gene Therapies, HFM-700
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH appeals:
Chief, Premarket Approval Section (HFZ-402)
Program Operations Staff
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
Section 738(d)(1) provides FDA “shall grant a waiver of the fee required . . . for one premarket application, or one premarket report, where . . . the applicant involved is a small business submitting its first premarket application . . . or its first premarket report . . . for review.”
This discussion assumes FDA has already found that you are a “small business”
(only a “small business” can obtain a waiver of the fee for its
first PMA or first PMR). If that is not the case, see question
3.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the supervisory
chain pursuant to 21 C.F.R. § 10.75
Appeals through the CDRH supervisory chain would proceed through:
Appeals through the CBER supervisory chain will follow the process described
by SOPP 8005, Major Dispute Resolution Process (February 1999), beginning
with the Director of the Office that was reviewing your application.
Special considerations: Only a small business is eligible for
a fee waiver for its first premarket application under section 738(d)(1). To
qualify for this waiver, you must establish your status as a small business
before you submit your first premarket application. If you have not qualified
as a small business at the time you submit your application, you must pay the
full fee for that application.
Recommended time frame for making your appeal: You should make
your appeal within 60 days of FDA’s determination that a premarket application
you submitted is not your first. FDA expects to respond to your appeal within
30 days.
Send your appeal to:
CBER appeals:
Director, Office of Blood Research and Review (HFM-300)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
or
Director, Office of Cell, Tissue, and Gene Therapies (HFM-700)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH appeals:
1 If you are requesting a waiver for your first premarket report (PMR) for a reprocessed single-use device and you submitted a premarket approval application (PMA), for the same device prior to October 1, 2002, you may still obtain a fee waiver for that PMR. See section 102(b) of MDUFMA (this waiver is not codified as part of the FD&C Act). This provision is intended to avoid penalizing an applicant who previously submitted a PMA for a reprocessed device, but who must submit a new application to satisfy requirements added by MDUFMA.Director, Program Operations Staff (HFZ-402)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
FDA’s Office of Combination Products (OCP) assigns the review responsibility
for a combination product based on the product’s “primary mode of
action.” Section 503(g)(1).
You may obtain an FDA determination concerning your combination product’s
primary mode of action by submitting a “Request for Designation”
(RFD) to OCP. OCP will make a determination within 60 days. The RFD process
is outlined in 21 C.F.R. Part 3; 21 C.F.R. § 3.7 outlines the information
we require in your RFD submission.
When OCP determines the primary mode of action of your product, that action
will also determine how FDA will review and regulate your product. For example,
when OCP determines that primary mode of action results from a drug component,
that product will be reviewed and regulated as a drug by the Center for Drug
Evaluation and Research. The primary review process may be subject to a user
fee, either under MDUFMA or the Prescription Drug User Fee Act (PDUFA). PDUFA
fees are higher than fees under MDUFMA, and may include both an application
fee and annual product and establishment fees.
Criteria: The term combination product is defined at 21 C.F.R.
§ 3.2(e):
Combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
The Office of Combination Products assigns primary jurisdiction for a combination product to a particular Center based on the “primary mode of action” of the product. In making its determination, OCP refers to -
FDA has published a proposed rule, Definition of Primary Mode of Action for
a Combination Product, 69 F.R. 25527 (May 7, 2004), but has not yet published
a final rule. If a final rule goes into effect, it will provide the criteria
FDA will use to determine primary mode of action. The proposed rule is available
at www.fda.gov/OHRMS/DOCKETS/98fr/04-10447.pdf.
OCP will provide additional information on its Internet site, www.fda.gov/oc/combination.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the supervisory
chain pursuant to 21 C.F.R. § 10.75
All appeals will proceed through:
Recommended time frame for making your appeal: You should make your appeal before you submit your application to FDA. FDA expects to respond to your appeal within 30 days.
Send your appeal to:
Director, Office of Combination Products (HF-7)
Office of the Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
If an issue remains unresolved after working with the lead Center, FDA’s Office of Combination Products (OCP) can help facilitate a resolution of the issue. OCP has published a draft guidance document that provides additional information and explains how OCP can help. See Combination Products — Timeliness of Premarket Reviews — Dispute Resolution Guidance, available at www.fda.gov/oc/combination/dispute.pdf.
The extent to which bundling is, or is not, permitted in a particular case
will determine whether the applicant pays a fee for a single application, or
multiple fees for multiple applications.
All bundled devices should be within a generic type of device, and it should
be possible for FDA to efficiently address all issues during the course of one
review.
Before you submit a bundled application to FDA, you should review FDA’s
guidance, Bundling Multiple Devices or Multiple Indications in a Single
Submission, available at —
www.fda.gov/cdrh/mdufma/guidance/1215.pdf
If you are unsure whether bundling is appropriate in your circumstances, you should contact FDA before you make your submission.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the supervisory
chain pursuant to 21 C.F.R. § 10.75
Appeals through the CDRH supervisory chain would proceed through:
Appeals through the CBER supervisory chain will follow the process described by SOPP 8005, Major Dispute Resolution Process (February 1999), beginning with the Director of the Office that was reviewing your application:
Recommended time frame for making your appeal: FDA expects
to respond to your appeal within 30 days.
Send your appeal to:
CBER appeals (send your appeal to the Office that would review your application):
Director, Office of Blood Research and Review (HFM-300)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448or
Director, Office of Cell, Tissue, and Gene Therapies (HFM-700)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH appeals:
Director, Program Operations Staff (HFZ-402)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
Under section 738(a)(1)(B)(v)(I), FDA does not assess a fee for any application,
or any supplement to an application, that is intended solely for a
pediatric population. If your application includes an indication for any adult
use, you must pay the fee that would normally apply to your application.
If you obtained a fee waiver for your original premarket application
(PMA, PDP, PMR, or BLA) because it was intended solely for a pediatric population,
and you later submit a supplement that proposes an adult condition of use, you
will be required to pay the fee that would apply to an original application
rather than the lower fee that would normally apply to your supplement. See
section 738(a)(1)(B)(v)(II).
FDA cannot confirm your claim that an application is limited to pediatric indications
until the application is filed and we have made significant progress in our
review of the application. If, during our review, we identify a proposed adult
use in an original application you claim is intended solely for a pediatric
population, we will put your application on hold and suspend our review because
under section 738(f) your application “shall be considered incomplete
. . . until all fees owed . . . have been paid.” We will inform you your
application is on hold, usually within a day. We will not resume our review
until you pay the appropriate fee, or you remove the proposed adult use from
your application, or an appeal determines there is no proposed adult use.
Similarly, if you obtained a fee waiver for your original application because
it was represented as solely for a pediatric population, and we identify a proposed
adult use in a later supplement to that application, and you did not include
payment for an original application, we will put your application on hold and
suspend our review, because under section 738(a)(1)(B)(v)(II) you must pay that
higher fee and under section 738(f) your application “shall be considered
incomplete . . . until all fees owed . . . have been paid.” We will inform
you your application is on hold, usually within a day. We will not resume our
review until you pay the appropriate fee, or you remove the proposed adult use
from your supplement, or an appeal determines there is no proposed adult use.
Examples of issues most likely to be presented on appeal:
Recommended appeals process: Internal review through the supervisory chain pursuant to 21 C.F.R. 10.75 —
Appeals through the CDRH supervisory chain would proceed through:
Appeals through the CBER supervisory chain will follow the process described by SOPP 8005, Major Dispute Resolution Process (February 1999), beginning with the Director of the Office that was reviewing your application.
Recommended time frame for making your appeal: You should
make your appeal within 60 days of FDA’s determination that your application
includes an indication for an adult use. FDA expects to respond to your appeal
within 30 days.
Send your appeal to:
CBER appeals: (Send your appeal to the office that was reviewing your application.)
Director, Office of Blood Research and Review, HFM-300
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448or
Director, Office of Cell, Tissue, and Gene Therapies, HFM-700
Center for Biologics Evaluation and Research
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448
CDRH appeals:
Director, Program Operations Staff (HFZ-402)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20857
Yes. FDA will grant all requests for refund of any portion of a payment that exceeds the correct fee for your application. Submit written documentation of your duplicate payment to the Center that received your application:
CDRH:
|
CBER:
|
Yes. FDA will automatically refund the fee you paid whenever we determine that our classification regulation exempts your device from the requirement to submit a premarket notification, or we determine your product is not a device. For additional information, see our guidance documents —
FDA will not refund any portion of a fee you paid if any one or more of the following situations —
• after we have accepted your 510(k) premarket notification;
• after we have accepted your 180-day PMA supplement;
• after we have accepted your real-time PMA supplement;
• after we have taken a first action on your application.
No refund after we have accepted your 510(k) premarket notification.
MDUFMA does not authorize a refund of any portion of a fee paid for a 510(k)
that is withdrawn, and FDA will not grant a refund once a 510(k) fee has been
paid and the 510(k) has been received. See FDA’s guidance document, User
Fees and Refunds for Premarket Notification Submissions (510(k)s), available
at www.fda.gov/cdrh/mdufma/guidance/1511.pdf.
No refund after we have accepted your 180-day PMA supplement or your
real-time PMA supplement. FDA considers your 180-day or real-time PMA
supplement to be filed as soon as we have received your supplement and you have
paid the fee due for the review. Under section 738(a)(1)(D)(iii), after FDA
has filed an application, we are to base any refund on the level of effort we
expended. Because the fees for these supplements are much lower than the fee
for an original premarket application and because these reviews are conducted
under a shorter period of time, we have determined that the level of effort
required to review these supplements is so significant that any refund would
be unwarranted.
For additional information, see FDA’s guidance, User Fees and Refunds for Premarket Approval Applications, available at www.fda.gov/cdrh/mdufma/guidance/1224.pdf.
No refund following a first action on your application. Under section 738(a)(1)(D), FDA does not have authority to grant a refund of any portion of a MDUFMA fee payment after we taken a first action. FDA will deny any request for a refund after we take a first action, and we will deny any appeal that requests a refund after a first action.
FDA expects to send you a check for the full amount of your refund within 30 days after we determine you are entitled to a refund.
You can obtain additional information and guidance on FDA’s appeals processes
by reviewing the guidance documents and SOPPs referenced in this document. If
you still have a question, contact —
CBER Ombudsman: (For information about CBER appeals)
CBER Ombudsman (HFM-4)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301-827-0379
Internet site: www.fda.gov/cber/inside/ombudsman.htm
CDRH Ombudsman: (For information about CDRH appeals)
CDRH Ombudsman (HFZ-5)
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
Phone: 301-827-7991
Internet site: www.fda.gov/cdrh/ombudsman
FDA Ombudsman: (For information about an appeal of FDA’s
designation of the primary review process for a combination product.)
Office of the Ombudsman (HF-7)
Office of the Commissioner
Food and Drug Administration
5600 Fishers Lane
Room 14B03
Rockville, MD 20857
Phone: 301-827-3390
Internet site: www.fda.gov/oc/ombudsman/homepage.htm
E-mail: ombuds@oc.fda.gov
FDA Office of Combination Products: (For information about how OCP
can help facilitate the resolution of issues concerning timeliness of reviews
of combination products.
Office of Combination Products (HFG-3)
Office of the Commissioner
Food and Drug Administration
Suite 200
15800 Crabbs Branch Way
Rockville, MD 20855
Phone: 301-427-1934
Internet site: www.fda.gov/oc/ombudsman/homepage.htm
E-mail: combination@fda.gov
For general information about MDUFMA, visit FDA’s web sites at —
For additional information on MDUFMA user fees and refunds, see —
Updated November 23, 2004
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