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 NON-
COMBINATION 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 OCPs 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 
 
2  Contains Nonbinding Recommendations 
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 (Pre-
RFD) 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 products 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 non-
combination 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 sponsors 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 
3  Contains Nonbinding Recommendations 
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.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys 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 
1
PRODUCTS  
 
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 
FDAs 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. 
4  Contains Nonbinding Recommendations 
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, OCPs 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 OCPs intent to 
provide the best advice possible based on the information provided in the Pre-RFD.  OCPs 
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 products 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). 
5  Contains Nonbinding Recommendations 
Submission Type  RFD   Pre-RFD 
(Information Required)  (Information Recommended)  
Description of Product  Yes  Yes 
Proposed Use or Indications  Yes  Yes 
for Use 
Description of the  Yes  Optional (if available; 
manufacturing processes,  recommended if it is a human 
including the sources of all  cell, tissue, or cellular- or tissue-
components  based product (HCT/P) or a 
biological product)  
Supportive Data/Studies   Yes  Optional (if available) 
Description of how a product  Yes  Yes 
achieves its intended 
therapeutic/diagnostic effects 
Analysis of Classification,  Yes  Optional (if available)  
Primary Mode of Action 
(PMOA), if it is a combination 
product, and Jurisdictional 
Assignment 
Description of Related  Yes  Optional (if available)  
Products 
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.   
6  Contains Nonbinding Recommendations 
In most cases, the Agency will be able to make its preliminary assessment based on a well-
written 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 Pre-
RFD 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.  
OCPs 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 
7  Contains Nonbinding Recommendations 
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 OCPs preliminary assessment? 
 
If you disagree with OCPs 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. 
 
8  Contains Nonbinding Recommendations 
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, companys 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. 
 
9  Contains Nonbinding Recommendations 
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. 
10  Contains Nonbinding Recommendations 
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 Pre-
RFD 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: 
 
11  Contains Nonbinding Recommendations 
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). 
12  Contains Nonbinding Recommendations 
VII.  Appendix:  
 
A. Pre-RFD Screening Checklist: 
 
1.  Contact information including your name, companys 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 
13  Contains Nonbinding Recommendations 
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. 
   
14  Contains Nonbinding Recommendations 
 
B. Pre-RFD Process Flow 
 
 
15