FDA 5004 Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

PRE-REQUEST FOR DESIGNATION (PRE-RFD) / INFORMAL SUBMISSION
The Pre-RFD / Informal submission process is available to provide informal, non-binding feedback regarding the 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.
We recommend that you complete the following form to guide you through the Pre-RFD / Informal submission process.

Contact Information for Sponsor/Applicant or Authorized Representative
Salutation

First Name

Last Name

Position

Company Name

Email Address (example@email.com)

Telephone Number (Example +01 123-456-7890)

Street Address

Extension (Example: 1234)

City/Town

State/Province/Region

OF

Country

O

PR

Product Information
Sponsor/Applicant Name

Postal Code

Common Name (The common name of the product)
Trade Name (The trade name of the product. If no trade name exists, re-enter the common name.)
Brief Product Description (Please provide 2 to 3 sentences describing the product.)

Indications for Use:

Requested Classification of Product (Optional, Select one)

Designer note: This form will be made as
a “508 compliant” Adobe LiveCycle PDF
with entry fields after FDA (along with
OMB, if applicable) gives final approval to
this “layout design” version.
Designer note: Radio Buttons

Biologic

Combination Product - Drug/Device

Device

Combination Product - Biologic/Device

Drug

Combination Product - Drug/Biologic

Other:

Combination Product - Drug/Device/Biologic
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P, Section 361 of PHS Act)

Sponsor Requested Center Assignment (Optional, Select one)
Center for Biologics Evaluation and Research (CBER)

Other:

Designer note: Radio Buttons

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

FORM FDA 5004 (09/20)

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PSC Publishing Services (301) 443-6740

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Have you previously had a submission to OCP for this product (e.g., RFD,
Pre-RFD)?
YES

If “YES,” enter previous submission number(s) (e.g.,
RFD, Pre-RFD; separate multiple entries with a semicolon).

NO

Are you updating or supplementing a pending Pre-RFD or Informal submission?
YES

If YES, enter the Pre-RFD / Informal submission number
associated with your revised Pre-RFD or responses.

NO

(This is an eight digit number that may contain leading zeros.)

Pre-market Submission(s) (Enter pre-market
submission type and number; separate multiple entries
with a semicolon)

Is there a pre-market submission (i.e., investigational application, marketing
application/submission, or any other FDA regulatory submission, e.g., a Qsubmission) for this product?
YES

NO

Submission Review 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.
1.

The 510(k), Premarket Approval Application (PMA), De Novo, New Drug Application (NDA), Abbreviated New Drug Application (ANDA),
Biologics License Application (BLA), or any other FDA regulatory submission

2.

Name of the product and all component products; and

3.

A photo/diagram of the product

F

number associated with the product.

O
RO

P

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. Although 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 configured and 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 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 method of action is achieved.
10.

For products that might be combination products, information that you might have, if any, to support the relative contribution of

different constituent parts to the overall intended therapeutic/diagnostic effects of the combination product. Although 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.
I have included the above sections for this Pre-RFD / Informal submission.

Once submitted, your request cannot be edited. Please make sure you have reviewed your submission before submitting to the Office of
Combination Products (OCP).

FORM FDA 5004 (09/20)

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PSC Publishing Services (301) 443-6740

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