Date
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Pre-Sub Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
OR
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center (HFM-99)
1401 Rockville Pike, suite 200N
Rockville, MD 20852-1448
Re.: Pre-Sub – Study Determination Request
Sponsor-Investigator:
[Name and Title]
[Department
Building if applicable
Institution]
Nashville, TN [Zip code]
Phone:
Fax:
Email:
Alternate Contact:
[Name and Title]
[Department
Building if applicable
Institution]
Nashville, TN [Zip code]
Phone:
Fax:
Email:
Dear Madam/Sir or <FDA contact if known>:
The information provided with this submission constitutes a request for a significant risk
or non-significant risk determination letter by the FDA. Included are 2 hard copies and 1
electronic copy of this determination submission, which includes information about the
device to be used in the study and a draft/outline of the study protocol.
Please contact myself or the contact person identified above for any questions. Thank you
in advance for your review and consideration of this submission.
Sincerely,
_______________________________________________
Signature of Sponsor-Investigator [Name and title]
_______________________________________________
Print Name
Note: The Form at the following link should be completed and included as the cover
page for this submission:
Form 3514
Table of Contents
DEVICE DESCRIPTION ................................................................................................................................
PROPOSED INTENDED USE/INDICATIONS FOR USE ............................................................................
PREVIOUS DISCUSSIONS OR SUBMISSIONS ..........................................................................................
OVERVIEW OF PRODUCT DEVELOPMENT .............................................................................................
SPECIFIC QUESTIONS ..................................................................................................................................
MECHANISM FOR FEEDBACK ...................................................................................................................
DRAFT PROTOCOL .......................................................................................................................................
DEVICE DESCRIPTION
*This section should describe each important component, ingredient, property, and
principle of operation of the device, including any software components or mobile
medical applications.
Consider the following elements in providing sufficient information regarding the device:

Whether the device is novel or includes novel technology; or has been previously
reviewed by the FDA

Review of published medical literature regarding the device or similar treatments

Scientific basis for development of the device or an explanation of its expected
clinical utility

Summary of prior preclinical testing (biocompatibility, in vitro performance
testing, in vivo animal testing)

Prior human experience

Detailed description of device (principles of operation/mechanism of action,
primary components and materials of each, dimensions; consider including
pictures, surgical technique guides or videos of the device’s use in the clinical
setting)

explanation of the user interface and/or how the device interacts with other
devices or with the user (medical professional and/or patient)

Brief explanation of how the device is manufactured

Compliance with relevant industry standards

Mechanical/engineering drawings

If the device is believed to be non-significant risk, include the rationale for same.
Note:

If the device is regulated by CBER and the biologic output is to be administered
to a patient, this output should be included in the description.

If the device is an IVD, provide a detailed technical description to include
instruments, reagents, components, software, principles of operation, and
accessories.

If output from the device is to be used, describe how the output is generated and
how the output will be used, including physical, chemical, or biological
principles/processes used to generate device output and physical and or
biological characteristics of the output.
PROPOSED INTENDED USE/INDICATIONS FOR USE
*Describe the intended use, indications for use, to include population parameters.
Include if the proposed indication makes the device a “first of a kind.”
Consider the following elements in providing sufficient information regarding the
proposed intended use/indications for use:





the disease or condition the device is indicated to prevent, mitigate, screen,
monitor, treat, or diagnose
the target population
the part of the body or type of tissue the device will be applied to or with which
the device is interacting
the frequency of use
the physiological use
Note: if the device is an IVD, include the analyte or condition to detect and the assay
methodology.
PREVIOUS DISCUSSIONS OR SUBMISSIONS
*This section should summarize any previous discussions or submissions (including
submission numbers) with the agency on this or a similar device.
If this section is not applicable, state
This section is not applicable as there have been no previous discussions or submissions
regarding this or a similar device.
OVERVIEW OF PRODUCT DEVELOPMENT
*This section should include an overview of the device’ development, including an
outline of nonclinical and clinical testing that is planned or has already been completed.
SPECIFIC QUESTIONS
*If you would like feedback from the FDA regarding the development of a protocol for a
significant or non-significant risk device, include the elements you would like addressed
in this section. Areas to which responses may be desired may include but are not limited
to planned nonclinical evaluations, clinical study protocols (if the device is not
significant risk), or data requirements. You should consult your regulatory guidance staff
member once your questions have been formulated to ensure appropriate formatting has
been utilized.
If you do not desire feedback, state
No specific questions are proffered at this time as we are seeking a risk determination
before moving forward.
MECHANISM FOR FEEDBACK
*Feedback may be obtained regarding this submission in a number of ways. These
include a formal written response, a meeting, a teleconference, email, or fax. If you have
a preferred means of receiving a response, you should indicate this request here.
Please provide a formal written response in regard to this submission.
PROTOCOL