How to Prepare a Pre-Request for 

Designation (Pre-RFD)

____________________________________________________ 

Guidance for Industry

Submit electronic comments to https://www.regulations.gov. Submit written comments to the 

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the 

notice of availability that publishes in the Federal Register. 

Additional copies of this guidance are available from the Office of Combination Products website at 

https://www.fda.gov/CombinationProducts/default.htm. 

For questions on the content of this guidance, contact the Office of Combination Products at 

combination@fda.gov

An agency may not conduct or sponsor, and a person is not required to respond to, 

a collection of information unless it displays a currently valid OMB control 

number. The OMB control number for this information collection is 0910-0845 

(expires October 31, 2020). 

See additional PRA statement in Section VI of the guidance.

U.S. Department of Health and Human Services

Food and Drug Administration 

Office of Combination Products in the Office of the Commissioner

February 2018 
Contains Nonbinding Recommendations

TABLE OF CONTENTS 

I. PURPOSE ................................................................................................................................ 3

II. BACKGROUND ..................................................................................................................... 3

III. GENERAL INFORMATION REGARDING THE PRE-RFD PROCESS FOR NONCOMBINATION AND COMBINATION PRODUCTS ............................................................... 4

A. What is a Pre-RFD? ............................................................................................................. 4

B. When should I submit a Pre-RFD? ...................................................................................... 6

C. May I request a meeting with OCP to explain my product? ................................................ 6

D. How do I submit a Pre-RFD for my product?...................................................................... 7

E. How promptly will FDA review my Pre-RFD? ................................................................... 7

F. May I withdraw my Pre-RFD after submission? ................................................................. 8

G. What if I disagree with OCP’s preliminary assessment? ..................................................... 8

H. How can I contact OCP? ...................................................................................................... 8

I. Where can I find more information? .................................................................................... 8

IV. WHAT INFORMATION SHOULD I INCLUDE IN A PRE-RFD? .................................. 9

A. What is the basic information that I should include in my Pre-RFD? ................................. 9

B. What if I have additional information about my product that I would like to share with 

FDA in my Pre-RFD? ............................................................................................................... 10

C. What format should I follow for my Pre-RFD? ................................................................. 10

D. Does FDA accept electronic submissions for Pre-RFDs? ................................................. 10

E. How should my Pre-RFD be addressed if I submit it via standard mail? .......................... 10

F. Is there a page limit for Pre-RFDs? ................................................................................... 11

V. CONCLUSION ..................................................................................................................... 11

VI. Paperwork Reduction Act of 1995 ..................................................................................... 11

VII. Appendix: ........................................................................................................................... 13

A. Pre-RFD Screening Checklist: ........................................................................................... 13

B. Pre-RFD Process Flow ....................................................................................................... 15

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How to Prepare a Pre-Request for Designation (Pre-RFD)

Guidance for Industry

This guidance represents the current thinking of the Food and Drug Administration (FDA or 

Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 

or the public. You can use an alternative approach if it satisfies the requirements of the 

applicable statutes and regulations. To discuss an alternative approach, contact the FDA office 

responsible for this guidance as listed on the title page. 

I. PURPOSE

This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S. 

Food and Drug Administration (FDA or Agency) through the Pre-Request for Designation (PreRFD) process. Specifically, this guidance explains the Pre-RFD process at the Office of 

Combination Products (OCP) and helps a sponsor understand the type of information to provide 

in a Pre-RFD. 

The Pre-RFD process is available to provide informal, non-binding feedback regarding the 

regulatory identity or classification of a human medical product as a drug, device, biological 

product, or combination product. In addition, this informal process provides information about a 

non-combination or combination product’s assignment to the appropriate Agency Center (Center 

for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health

(CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and 

regulation. 

Additional information on topics outside the scope of this guidance may be found on our website 

(at http://www.fda.gov/CombinationProducts/default.htm.) These topics include the definitions 

of a non-combination and combination product, as well as information about the formal Request 

for Designation (RFD) process. 

II. BACKGROUND

Since its establishment on December 24, 2002, OCP has served as a resource for sponsors at 

various stages of development of their product. Sponsors often seek OCP feedback on whether 

their medical product will be regulated as a drug, a device, a biologic, or a combination product, 

and which FDA medical product Center (CDER, CBER, or CDRH) will regulate it, if it is a noncombination product, or will have the primary jurisdiction for the premarket review and 

regulation of the product, if it is a combination product. 

There are two ways that a sponsor can receive such a feedback from OCP. One option is to 

submit an RFD to receive a formal, binding determination for the sponsor’s product with respect 

to classification and/or center assignment that may be changed under conditions specified in 

section 563 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act and 21 CFR 3.9 in the 

regulations. The RFD process is codified in 21 CFR Part 3, and OCP has issued a guidance 

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about this process (see “How to Write a Request for Designation” at 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second more 

flexible option is for a sponsor to submit an inquiry to OCP to receive a preliminary 

jurisdictional assessment, which is not binding. 

Many sponsors seek to utilize more flexible approachable ways to interact with OCP and the 

medical product Centers to obtain feedback from the Agency before submitting a marketing

application to the Agency. Over time, these informal methods of obtaining feedback have 

become increasingly customary with sponsors, and for some, even preferable to the formal RFD 

process. Accordingly, FDA is enhancing the transparency and consistency of the process, which 

will now be called the “Pre-Request for Designation (Pre-RFD) Program,” available through 

OCP. This guidance describes this structured process with clear recommendations for sponsors 

wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, 

the general timeframes for sponsors to receive feedback from OCP, and the process for 

scheduling teleconferences and meetings in relation to a Pre-RFD. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 

be viewed only as recommendations, unless specific regulatory or statutory requirements are 

cited. The use of the word “should” in Agency guidance documents means that something is 

suggested or recommended, but not required. 

III. GENERAL INFORMATION REGARDING THE PRE-RFD 

PROCESS FOR NON-COMBINATION AND COMBINATION 

PRODUCTS1

A. What is a Pre-RFD?

A Pre-RFD is a clear and concise written submission that a sponsor may make to OCP to request

FDA’s preliminary, nonbinding assessment of (1) the regulatory identity or classification of a 

product as a drug, device, biological product, or combination product, and/or (2) whether CBER, 

CDER, or CDRH will regulate the product if it is a non-combination product, or which of those 

Agency Centers will have primary jurisdiction for the premarket review and regulation, if it is a 

combination product. 

OCP will provide a written preliminary classification and/or jurisdictional assessment of the 

product based on the information provided in a specific Pre-RFD. Our goal is to provide you 

with our feedback within 60 calendar days of receipt of the basic information that you should 

provide, and we will communicate with you during our review as needed. You can also contact 

us at any time during the review to ask questions or get clarification. Moreover, if it appears that 

1 For the purposes of this guidance document, parties who submit a Pre-RFD to the Agency are referred to as 

“sponsors,” “you” or “your”; the terms “we,” “us,” and “our” refer to FDA staff from the Office of Combination 

Products.

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we will not be able to complete our review within 60 calendar days after receipt of the 

information, we will communicate the need for more review time to you in a timely manner. 

Please note that if you change your product significantly after submitting the Pre-RFD to us, 

such as changing its indication or ingredients, OCP’s feedback may no longer be applicable. 

Accordingly, we recommend that you contact OCP if you make such a change. Additionally, if 

you have classification or assignment questions regarding multiple related products or product 

families that have different configurations, ingredients, and/or proposed uses or indications, we 

recommend submitting a separate Pre-RFD for each product. 

Though our Pre-RFD feedback is not binding on the Agency or sponsor, it is OCP’s intent to 

provide the best advice possible based on the information provided in the Pre-RFD. OCP’s 

review and written feedback will be made after an in-depth review, and it will contain a thorough 

and detailed rationale for our assessment. Moreover, our review will include involvement from 

the relevant Agency Centers, as well as the Office of Chief Counsel when necessary.

The following table highlights some of the key similarities and differences between the RFD and 

Pre-RFD processes.2

 Regarding similarities, in both processes certain basic information is 

needed for FDA to provide an assessment of the classification and assignment of a product. The 

basic information includes, for example, a description of the product, proposed use or 

indications, and a description of how the product achieves its intended therapeutic/diagnostic 

effects. In addition, a sponsor has the option to include additional information in a Pre-RFD that 

would be required for an RFD. 

Differences between the RFD and Pre-RFD process include length of submission and depth of 

regulatory analysis that a sponsor must provide. For example, RFDs cannot exceed 15 pages, but 

no such length requirement exists for Pre-RFD submissions.3

 Moreover, for an RFD, a sponsor 

must provide an analysis of a product’s classification, a primary mode of action (PMOA) 

analysis (if the RFD concerns combination product assignment), and a recommendation 

regarding Agency Center assignment. Such information is optional in the Pre-RFD process

(additional details are provided in Section IV.A. and in Appendix A). We note that FDA would 

conduct the same type of PMOA analysis in a Pre-RFD as in a RFD regardless of whether a 

sponsor chooses to make a recommendation regarding the PMOA of its combination product in a 

Pre-RFD. 

2 Please note that the information listed in this Pre-RFD Guidance does not include all the necessary information 

required for an RFD. If you wish to submit an RFD, you should consult 21 CFR 3.7 as well as the guidance about 

what to include in an RFD (see “How to Write a Request for Designation” at 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm).

3 Although there is no page limit for Pre-RFDs, we encourage you to limit your Pre-RFD to a succinct summary of 

information relevant for OCP to make its preliminary assessment (see Sections III.E and IV.F).

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Submission Type RFD

(Information Required)

Pre-RFD

(Information Recommended) 

Description of Product Yes Yes

Proposed Use or Indications

for Use

Yes Yes

Description of the 

manufacturing processes, 

including the sources of all 

components 

Yes Optional (if available; 

recommended if it is a human 

cell, tissue, or cellular- or tissuebased product (HCT/P) or a

biological product)

Supportive Data/Studies Yes Optional (if available)

Description of how a product 

achieves its intended 

therapeutic/diagnostic effects

Yes Yes

Analysis of Classification, 

Primary Mode of Action 

(PMOA), if it is a combination 

product, and Jurisdictional 

Assignment

Yes Optional (if available)

Description of Related 

Products

Yes Optional (if available)

Sponsor Recommendation Yes Optional (if available)

Page limit Yes No4

B. When should I submit a Pre-RFD? 

A Pre-RFD may be submitted at any point during medical product development. 

A Pre-RFD is especially beneficial when the classification of a product or the Agency Center to 

which it should be assigned is unclear or in dispute and your product is very early in its 

development, or if you are contemplating whether to pursue a specific configuration or a specific 

indication. Understanding how FDA regulates your product and the appropriate regulatory 

pathway to market for your product will help lead to better decision-making for your company. 

We note that a Pre-RFD is not necessary for every product. For example, some products have 

clearly established classification and jurisdictional assignments. OCP has published a list of 

various examples of these types of products on its website at combination@fda.gov. 

C. May I request a meeting with OCP to explain my product?

We encourage you to contact OCP before submitting your Pre-RFD if you have any questions, 

including if you are uncertain about the type of information to include. 

4 See footnote 3. 

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In most cases, the Agency will be able to make its preliminary assessment based on a wellwritten Pre-RFD. However, if you believe a meeting with OCP would be helpful in providing the 

Agency with a better understanding of how the product works, you can request a meeting either 

prior to or after submission of a Pre-RFD. If you request a meeting after submission of a PreRFD but prior to our feedback, please keep in mind that such a meeting will potentially extend 

the timeframe of review of your product, so that we can adequately consider issues raised during 

the meeting. 

If you request a meeting, you should include an explanation of the issues you would like to 

address and any supportive information. Please note that the timing to schedule meetings may 

vary based on factors including the number of subject matter experts to be included from 

interested Agency Centers, the availability of conference rooms, and the complexity of the issues 

the product raises. When possible and appropriate, OCP encourages you to consider a 

teleconference instead of an in-person meeting. 

Generally speaking, FDA will need about four weeks to review information submitted as part of 

the meeting request prior to the meeting. This timeframe will give OCP and the necessary 

subject matter experts from the Agency Centers adequate time to review, comment, and possibly 

follow-up on any issues prior to your meeting. Therefore, it is very important that you provide 

complete background information at the time of your initial meeting request. If you wish to 

supplement your background information package with any new or modified information after 

this date, we may have to reschedule the meeting or delay our feedback on discussion topics 

related to the new or updated information. While it is important to provide a complete 

background package, submission of extraneous information can be counterproductive. In order 

for us to provide the most efficient and beneficial advice to you, please keep your background 

information targeted and focused on the issues in your Pre-RFD that you would like us to 

consider. 

D. How do I submit a Pre-RFD for my product?

Part III of this document addresses the recommended format and specific content of a Pre-RFD 

in detail. You may submit a Pre-RFD, and include any relevant data pertaining to your product, 

which should be clearly labeled as such, to combination@fda.gov or to the address listed below 

in Section IV.E. 

E. How promptly will FDA review my Pre-RFD?

Within 5 business days of its receipt of a Pre-RFD, OCP aims to review the Pre-RFD submission 

to ensure that it has adequate information for us to make our preliminary assessment. OCP will 

then either send you an acknowledgement email that our assessment will proceed, or we will 

detail the additional information needed before we can begin our assessment. 

OCP’s goal is to provide feedback on a Pre-RFD within 60 calendar days after we receive 

complete information to begin our review. However, please keep in mind that the speed of the 

review depends on the quality and adequacy of the information submitted. Furthermore, if you 

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choose to submit a large amount of data for FDA to consider, it may be necessary for us to take 

longer than our goal of 60 calendar days to fully consider the information provided. 

F. May I withdraw my Pre-RFD after submission?

Yes, you may withdraw your Pre-RFD by notifying OCP in writing, via email or correspondence 

sent to the address below in section IV.E., any time after its submission and before FDA issues 

its preliminary assessment. 

G. What if I disagree with OCP’s preliminary assessment?

If you disagree with OCP’s preliminary assessment of your product, you may contact our office 

to discuss our findings. After receiving our feedback, should you wish to present additional 

information or new data that was not presented in the original Pre-RFD, we encourage you to 

contact our office to discuss such additional information. We will be happy to provide you with 

assistance before you submit a new Pre-RFD. Once you submit a new Pre-RFD to us, OCP will 

consider this Pre-RFD a new submission and provide it with a new review and thorough 

assessment. 

Alternatively, you can submit an RFD for our consideration (see 21 CFR Part 3 and the guidance 

document “How to Write an RFD” for additional information on the necessary information, 

format, and page limit for an RFD). Once your RFD has been reviewed for completeness and 

accepted for filing, we will review the RFD and provide, within 60 calendar days of filing, a 

binding determination with respect to classification and/or center assignment that may be 

changed under conditions specified in section 563 of the FD&C Act and 21 CFR 3.9 in the 

regulations. If you disagree with the RFD decision, you may appeal that decision in accordance 

with 21 CFR 10.75. 

H. How can I contact OCP?

Contact information for OCP, including mailing address, e-mail address, phone number, and fax 

number are listed below in Part IV.E. 

I. Where can I find more information?

More information about product classification and assignment, as well as the regulation of 

combination products, is available on the OCP website at 

https://www.fda.gov/CombinationProducts/default.htm.

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IV. WHAT INFORMATION SHOULD I INCLUDE IN A PRE-RFD?

A. What is the basic information that I should include in my Pre-RFD?

1. Contact information including your name, company’s name, email address, and 

telephone number. 

2. A complete description of the product and, if applicable, the following 

information. 

a. The 510(k), Premarket Approval (PMA), New Drug Approval (NDA), 

Abbreviated New Drug Approval (ANDA), Biologics License Application 

(BLA), or any other FDA regulatory submission number associated with 

the product. 

b. Name of the product and all component products; and

c. A photo/diagram of the product 

3. For products sourced from biologically-derived materials, describe how the 

material was processed and a characterization of the identity of the final product. 

4. An explanation of how the product works. And, though optional, you may 

include additional information describing details (i.e., study conditions/methods, 

identification of controls, results and conclusions) of relevant testing that supports 

how the product works. Please be aware that comparisons to other products or 

biocompatibility testing are typically not helpful in understanding how the 

product works. 

5. An explanation of how the product will be marketed. For instance, will the 

product have separately marketed constituent parts that are to be labeled for use 

together, or will it have components that either will be physically or chemically 

combined to make a single entity or will be co-packaged? 

6. A listing of all components/ingredients, including the amount and reasoning for 

including each component/ingredient, in the product. If the product contains a 

solution/liquid/gel/powder, please provide a listing of all ingredients (active and 

inactive), their amount/concentration, and the reason for including the ingredient 

in the product. 

7. Proposed use/intended use/indications for use statement. 

8. Instructions for use/conditions of use. 

9. All known methods of action and the mechanism(s) by which each is achieved. 

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10. For products that might be combination products, any information that you might 

have, if any, to support the relative contribution of different components to the 

overall intended therapeutic/diagnostic effects of the combination product. 

Though optional, you may provide a detailed description of any supporting 

tests/studies if such information is available and you would like FDA to consider 

the information. 

11. A list of claims that you intend to make or have made regarding the product. 

B. What if I have additional information about my product that I would 

like to share with FDA in my Pre-RFD?

In addition to the above requested information needed for FDA to conduct a Pre-RFD review, 

you may also choose to provide additional information about a product. Information beyond that 

which is listed in Section IV.A is optional. However, in the event that you have prepared other 

information that you wish us to consider, we would be happy to do so. This information might 

include, for example, a recommendation for lead Center, if your product is a combination 

product, or any products that you believe may be similar to your product, or any other 

information that you consider relevant for us to consider during our preliminary assessment.5

C. What format should I follow for my Pre-RFD?

We recommend that you concisely provide the information identified in the screening checklist 

in the Appendix and explained in detail in the above sections. It would be helpful if you include 

for each section of the Pre-RFD a separate heading that corresponds to the headings listed in the 

screening checklist followed by your response. We also recommend you use a standard typeface 

(e.g., Times New Roman), which should be in an easily readable font size (e.g., 12). 

D. Does FDA accept electronic submissions for Pre-RFDs?

Yes. You may submit your Pre-RFD by e-mail to combination@fda.gov in a common electronic 

format, such as a Portable Document Format (PDF) or a Word Document. As explained in the 

preceding section, only one electronic submission is necessary.

E. How should my Pre-RFD be addressed if I submit it via standard mail? 

We encourage you to submit your Pre-RFD electronically to our inbox at combination@fda.gov. 

However, if you choose to submit your Pre-RFD via standard mail, you should send it to the 

following address: 

5 We note that to the extent any information a sponsor provides in a Pre-RFD is trade secret or confidential 

commercial information, such information is protected by the same confidentiality laws as those that protect such 

information provided in an RFD.

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Office of Combination Products 

Office of the Commissioner

Food and Drug Administration 

WO32 Hub/Mail Room #5129 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002 

In order for the Pre-RFD to be sent to the correct location, the envelope should be clearly marked 

as a “Pre-Request for Designation.” Only one Pre-RFD submission is necessary. In other words, 

no copies of your original Pre-RFD submission are required. 

F. Is there a page limit for Pre-RFDs?

No, there is no page limit for Pre-RFDs (nor is there a word limit for emailed Pre-RFD 

submissions that are not in PDF or Word format). However, we encourage you to limit your PreRFD to a succinct summary of information relevant for OCP to make its preliminary assessment. 

V. CONCLUSION

This guidance provides our recommendations for the format and content of a Pre-RFD 

submission. We recommend you pay particular attention to these sections of your Pre-RFD, as 

applicable:

• A complete description of the product, including its composition (what is your product?); 

• The intended use/indications for use of the product (why would your product be used?); 

• The methods of action of the product (how does your product work?); 

• If your product may be a combination product, information you may have, if any, 

regarding the relative contribution of each of its components to the overall intended 

therapeutic/diagnostic effects of the combination product; and

• Any claims you have made or plan to make about your product. 

OCP is always available as a resource to you. We strongly encourage you to contact OCP before 

submitting your Pre-RFD if you have any questions, or if you are uncertain about the type of 

information to include. 

VI. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office 

of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 

3501-3520). 

The time required to complete this information collection is estimated to average 13 hours per 

response, including the time to review instructions, search existing data sources, gather the data 

needed, and complete and review the information collection. Send comments regarding this 

burden estimate to: 

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Department of Health and Human Services

Food and Drug Administration 

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov 

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 

information unless it displays a currently valid OMB control number. The OMB control number 

for this information collection is 0910-0845 (expires October 31, 2020).

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VII. Appendix: 

A. Pre-RFD Screening Checklist: 

1. Contact information including your name, company’s name, email address, and 

telephone number. 

2. A complete description of the product and, if applicable, the following 

information. 

a. The 510(k), PMA, NDA, ANDA, BLA, or any other FDA regulatory 

submission number associated with the product. 

b. Name of the product and all component products; and 

c. A photo/diagram of the product 

3. For products sourced from biologically-derived materials, describe how the 

material was processed and a characterization of the identity of the final product. 

4. An explanation of how the product works. Though optional, you may provide 

additional information describing details (i.e., study conditions/methods, 

identification of controls, results, and conclusions) of relevant testing that 

supports how the product works. Please be aware that comparisons to other 

products or biocompatibility testing are typically not helpful in understanding 

how the product works. 

5. An explanation of how the product will be marketed (e.g., kit configuration). For 

instance, will the product have separately marketed constituent parts that are to be 

labeled for use together, or will it have components that will be physically or 

chemically combined to make a single entity or co-package?

6. A listing of all components/ingredients, including the amount and purpose for 

including each component/ingredient, in the product. If the product contains a 

solution/liquid/gel/powder, please provide a listing of all ingredients (active and 

inactive), their amount/concentration, and the reason for including each ingredient 

in the product. 

7. Proposed use/intended use/indications for use statement. 

8. Instructions for use/conditions of use. 

9. All known methods of action and the mechanism(s) by which each is achieved.

10. For products that might be combination products, information that you might 

have, if any, to support the relative contribution of different components to the 

overall intended therapeutic/diagnostic effects of the combination product. 

Though optional, you may provide detailed description of any relevant 

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tests/studies if such information is available and you would like FDA to consider 

the information.

11. A list of claims that you have made or plan to make regarding the product.

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B. Pre-RFD Process Flow

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