FDA 3514 CDRH Premarket Review Submission Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: Xxxxxxx xx, 201x
See PRA Statement on last page.

CDRH PREMARKET REVIEW SUBMISSION COVER SHEET
Date of Submission

User Fee Payment ID Number

SECTION A
PMA & PDP
Original
Modular Submission
Amendment
Report (annual or PAS)
Report Amendment

TYPE OF SUBMISSION
PMA/PDP Supplement
180 day - PAS protocol or
labeling change, location
change, trade name
change
180 day - Design or
labeling change

Licensing Agreement

Amendment to PMA/PDP
Supplement

Real-time Review

Amendment to
Original IDE
Supplement:
Amendment to
Supplement

Q-Submission
Pre-Submission
Informational Meeting

Special

Original

Submission Issue Meeting

Abbreviated

Amendment

Day 100 Meeting
Agreement Meeting

CLIA Waiver by Application
(CW)

Dual Track (Dual
510(k) and CLIA
Waiver by Application)

30-day Notice

HDE

Traditional

3rd Party Abbreviated

Premarket Report
(reprocessed SUD)

IDE

CLIA
CLIA Categorization Record
(CR)

3rd Party Special

Panel Track

Original IDE:

510(k)
Original Submission:

3rd Party Traditional

Special CBE
Other:

FDA Submission Document Number (If known)

Original

Determination Meeting
Study Risk Determination
Other (Specify below)

Amendment
Supplement

Amendment
Supplement

Original Submission

Class II Exemption
Petition

Amendment to Original

Original Submission

Direct

Appeal

Report

Additional Information

Post-NSE

Other (Briefly describe
submission below)

De Novo
Original:

Report Amendment

Amendment

HDE Supplement:

Supplement

Report:
Amendment to Report

Other Submission
513(g)

75-day Supplement
30-day Notice
Special CBE
Amendment to
Supplement

Emergency Use
Authorization

Pre-Emergency Use
Authorization

Original

Original

Supplement

Supplement

Amendment

Amendment

Report

Expanded Access to Devices
Compassionate Use Request NOT associated with an IDE
Follow-up Report for Compassionate Use NOT associated with an IDE
Emergency Use Follow-up Report NOT associated with an IDE

SECTION B

APPLICANT / SPONSOR

Company/Institution Name

Establishment Registration Number/FEI (if known)

Street Address

City

State/Province

Contact Name

ZIP/Postal Code

Country

Contact Title

Division Name (if applicable)
Fax Number (including area code)

FORM FDA 3514 (6/16)

Phone Number (including area code)
Contact Email Address

Page 1 of 7

PSC Publishing Services (301) 443-6740

EF

SECTION C

OFFICIAL CORRESPONDENT (e.g., may be a consultant and/or 510(k) Third Party) (if different from Section B)

Company/Institution Name

Establishment Registration Number/FEI (if known)

Street Address

City

State/Province

ZIP/Postal Code

Contact 1 Name

Country

Contact 1 Title

Contact 1 Division Name (if applicable)
Contact 1 Fax Number (including area code)

Contact 2 Name

Contact 1 Phone Number (including area code)
Contact 1 Email Address

Contact 2 Title

Contact 2 Division Name (if applicable)
Contact 2 Fax Number (including area code)

Contact 3 Name

Contact 2 Phone Number (including area code)
Contact 2 Email Address

Contact 3 Title

Contact 3 Division Name (if applicable)
Contact 3 Fax Number (including area code)

Contact 3 Phone Number (including area code)
Contact 3 Email Address

To add another set of Section C items, please click on the button to the right. May be repeated as needed.

SECTION D

INTENDED USE POPULATION

Check all that apply.
Adults Only (greater than 21 years of age)

Neonate/Newborn (birth through 28 days)

Adults and Pediatrics

Infant (from 29 days to 2 years of age)

Other (Specify below)

Child (from 2 years to 12 years of age)
Adolescent (from 12 years to 18 years of age)
Transitional Adolescent A (18 through 21
years of age)
Transitional Adolescent B (18 through 21
years of age)

SECTION E

PRODUCT INFORMATION – APPLICABLE TO ALL SUBMISSIONS
Trade Name

1
2
3
4
5

Common/Generic Name (Include if no Trade Name)

FORM FDA 3514 (6/16)

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Add Section C

SECTION F

PRIOR RELATED SUBMISSIONS FOR THIS DEVICE OR STUDY

FDA document numbers of all prior related submissions (regardless of outcome) or state no prior submission in box 1.
1

2

3

4

5

6

7

8

9

10

11

12

SECTION G

PRODUCT CLASSIFICATION – APPLICABLE TO ALL SUBMISSIONS

Product Code(s) (when applicable) (If more than one, please separate with commas.)

C.F.R. Section (If applicable)

Classification Panel/Medical Specialty

Device Class
Class I

Class II

Class III

SECTION H1

Unclassified

REASON FOR APPLICATION – PMA, PDP, OR HDE

New Device

Change in Design, Component, or
Specification:

STED

Post-approval Study Protocol

Location Change:
Manufacturer

Software/Hardware

Sterilizer

Color Additive

Packager

Material
Specifications

Report Submission:

Other (Specify below)

Annual or Periodic

HDE Request for Annual Distribution
Number (ADN)

Post-approval Study

Process Change:

Labeling Change:

Amendment:

Manufacturing

Indications

Withdrawal

Packaging

Instructions

Change in Ownership

Sterilization

PAS update

Change in Correspondent

Vendor/Supplier Change

Performance Characteristics

Change of Address

Other (Specify below)

Shelf Life

Request for Extension

Trade Name

Response to FDA Correspondence

Other (Specify below)

Other (Specify below)

Bundle Submission – If this is selected, list in the spaces below any PMAs in the Bundle.
1

2

3

4

5

6

7

8

9

FORM FDA 3514 (6/16)

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SECTION H2

REASON FOR APPLICATION – IDE

Original IDE

Report:
Adverse Effect

Supplement:

Supplement (Continued)

Final, Study Completed

New Study/New Protocol

Request for Waiver

Annual Progress

Change in Correspondent

IRB Certification

Interim Progress

Change in Manufacturer

Request for CMS Recategorization

Semiannual Investigator List

Change in Sponsor

Study Resumed

Failure to Obtain Informed Consent

Change in Design

Study Suspension

Compassionate Use Follow-up

Change in Informed Consent

Other (Specify below)

Emergency Use

Change in Manufacturing

Live Case Follow-up

Change in Protocol

Completion of Patient Enrollment

5-Day Notice – Device or Manufacturing

Completion of Patient Follow-up

5-Day Notice – Protocol

Other (Specify below)

Compassionate Use Request (under an IDE)
Live Case Request
Request Deviation from Protocol
Expansion of Study (Study/Sites)
Extension of Time to Submit Annual Report or
Respond to FDA Letter
Amendment to Original IDE:

Amendment to Supplement:

Amendment to Report:

Amendment Before Final Decision

Response to Disapproval

Response to Deficiency Letter

Response to Refuse to Accept

Response to Approval with Conditions

Withdrawal

Response to Disapproval

Withdrawal

Response to Approval with Conditions

Amendment Before Final Decision
(additional Information)

Withdrawal

Amendment Before Final Decision
(additional Information)

Other (Specify below)

Other (Specify below)

SECTION H3

Other (Specify below)

REASON FOR SUBMISSION – Q-SUBMISSION

Pre-Submission:

Submission Issue Meeting:

Additional Information

Request Face-to-Face Meeting

Request Face-to-Face Meeting

Request Teleconference

Request Teleconference

Request Email Response

Request Email Response

Change in Correspondent

Submit Meeting Minutes

Submit Meeting Minutes

Change in Sponsors

Request Meeting Minutes Disagreement
T-con

Request Meeting Minutes Disagreement
T-con

Change in Manufacturer

Agreement Meeting:

Determination Meeting:

Change in Legal Entity:

Other (Specify below)

Informational Meeting:

Request Face-to-Face Meeting

Request Face-to-Face Meeting

Request Face-to-Face Meeting

Request Teleconference

Request Teleconference

Request Teleconference
Submit Meeting Minutes
Request Meeting Minutes Disagreement
T-Con

Other (Specify):

FORM FDA 3514 (6/16)

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SECTION H4

REASON FOR SUBMISSION – 510(k)

Original

Amendment Before Final Decision:

Withdrawal of Original

Supplement:

Change in Ownership

Response to Refuse to Accept (RTA)

Change in Correspondent

Response to Additional Information
Request

Withdrawal

Withdrawal

Amendment After Final Decision
Reprocessed SUD

Corrective Action

Third Party (Complete Section C)

STED

Other Reason (Specify):

Information on devices to which substantial equivalence is claimed (If known)
510(k) Number

Trade Name

Submitter

Product Code

Primary Predicate (A)
Predicate or
Reference Device (B)

To add another Predicate or Reference Device (B) entry row, please click on the button to the right. May be repeated as needed.

SECTION H5
Post NSE De Novo:

DE NOVO SUBMISSIONS
Number of the 510(k) that was NSE’d in the past 30 days:

Withdrawal

SECTION H6

REASON FOR APPLICATION – CLIA

Includes CLIA Parent Document number, CR number, or CW number.
CLIA Categorization Record (CR):
CLIA Categorization of marketed device (include marketing submission number)
CLIA Categorization of device exempt from premarket review
Additional information regarding an open CR (include CR number)

CLIA Waiver by Application (CW):
Request for CLIA Waiver by Application for marketed device (include marketing submission number)
Request for Dual 510(k) Clearance and CLIA Waiver by Application (include Pre-submission number)
Response to FDA correspondence
Additional information regarding an open CW (include CW number)

Other Reason (Specify)

FORM FDA 3514 (6/16)

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Add Device
Information

SECTION I

MANUFACTURING / PACKAGING / STERILIZATION SITES RELATING TO A SUBMISSION
Applicable only to IDEs
FDA Document Number (if known)

Note: Submission of this information does not affect Registration and Listing.
Facility Establishment Identifier (FEI) Number

Original
Add

Delete

Manufacturer

Contract Sterilizer

Contract Manufacturer

Repackager/Relabeler

Company/Institution Name

Establishment Registration Number/FEI (if known)

Street Address

City

State/Province

ZIP/Postal Code

Contact 1 Name

Country

Contact 1 Title

Contact 1 Division Name (if applicable)

Contact 1 Phone Number (including area code)
Contact 1 Email Address

Contact 1 Fax Number (including area code)

Contact 2 Name

Contact 2 Title

Contact 2 Division Name (if applicable)

Contact 2 Phone Number (including area code)
Contact 2 Email Address

Contact 2 Fax Number (including area code)

Contact 3 Name

Contact 3 Title

Contact 3 Division Name (if applicable)

Contact 3 Phone Number (including area code)
Contact 3 Email Address

Contact 3 Fax Number (including area code)

To add another set of Section I items, please click on the button to the right. May be repeated as needed.

SECTION J

Add Section I

UTILIZATION OF STANDARDS

Note: Please see guidance document titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”
for details on the Declaration of Conformity.
How to fill out this section:
Recognition Number: State the FDA recognition number. If the standard is not recognized, write NR.
Declaration of Conformity or General Use: Select ‘Declaration of Conformity’ if including a “Declaration of Conformity to a Recognized
Standard” statement. For all other uses, select ‘General Use’ and indicate if you have made deviations from the Recognized/Non-recognized
standard.
Standard: State the Standards Development Organization (SDO), the Designation Number (including year), and the Title.
Location: State the section and/or the page number(s) in the submission where the standard is applied.

Examples
Recognition
Number

1
X

2
X

Standards Development Organization (SDO),
Designation Number-Year, and Title

Location

If General Use, Deviation?

ASTM F451-08, standard specification for acrylic bone
cement.

Section 3,
p. 15

If General Use, Deviation?

AAMI ANSI BP22:1994 (R) 2011 Blood Pressure
Transducers

Section 4,
p. 32

Declaration of Conformity or General Use

8-185

Declaration of Conformity

3-44

General Use

FORM FDA 3514 (6/16)

Yes

Page 6 of 7

Entries for Utilization of Standards
Recognition
Number

Declaration of Conformity or General Use

1

Standards Development Organization (SDO),
Designation Number-Year, and Title

Location

If General Use, Deviation?

X

To add another row for Section J, please click on the button to the right. May be repeated as needed.
(To remove a particular row, please click on the “X” button at the beginning of the row.)

SECTION K

Add Row/Standard

UTILIZATION OF CDRH GUIDANCE DOCUMENTS

How to fill out this section:
Title: Enter the title of the guidance documents used in the preparation of your premarket submission. CDRH guidance documents can be found
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

Entries for Utilization of CDRH Guidance Documents
Title of Guidance Document

1
X

To add another row for Section K, please click on the button to the right. May be repeated as needed.
(To remove a particular row, please click on the “X” button at the beginning of the row.)

Add Row/Document

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FORM FDA 3514 (6/16)

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