First Year (one time)

Submission Report

Submission Report
Section: Report

Introduction

ISO 13485 Voluntary Audit Report Program
Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which
amends section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C.
374 (g)(7)) was amended to add the following provision:
"(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall
accept voluntary submissions of reports of audits assessing conformance with appropriate
quality system standards set by the International Organization for Standardization (ISO)
and identified by the Secretary in public notice. If the owner or operator of an
establishment elects to submit audit reports under this subparagraph, the owner or
operator shall submit all such audit reports with respect to the establishment during the
preceding 2-year periods."
Effective October 1, 2011, FDA will begin a two year voluntary pilot program as described in
the guidance document entitled "Medical Device ISO 13485:2003 Voluntary Audit Report
Submission Pilot Program" found at [web address]. FDA will evaluate the outcomes of the
pilot program at the end of this period. It is important to note that participation in the
Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program is entirely
voluntary.
Complete the following question and answer form, as well as attach the necessary PDF files
to submit your ISO 13485 Audit Reports to FDA's Center for Devices and Radiological Health
via the FDA Electronic Submissions Gateway (ESG). To register with the FDA ESG, go to
www.fda.gov/esg/.
Blue dots indicate required fields.
1.0 Inspection Date
Warning:

Your submission must be sent in within the last 90 days of an audit.

Submission Report

Has an audit been performed in the last 90 calendar days?

* Yes

2.0 Contact Information

Contact Information
Applicant Contact Information should be completed by the requester or submitter. The
applicant will act as the primary point of contact for this ISO 13485 Audit Report Submission.
Definitions
Company - Refers to the organization as a whole for a specific contact reference point.
Establishment - Refers to the physical location of a facility.
Tips
The Address Book function can store re-usable contact information across multiple
eSubmitter report types. Click the link below to view instruction on how to use the Address
Book.
Address Book User Guide
2.1 Establishment Contact Information
Information:

Enter the facility contact information that was audited including the most responsible person.

Warning:

The FDA Establishment Identifier (FEI) will be validated upon FDA receipt. Any invalid FEI numbers
and Establishment addresses will be rejected.

Establishment Contact Information
Contact Information:
Contact Name
Occupation Title
Email Address
Address

*

Submission Report

Establishment Name
Division Name
Address
Telephone Number
FDA Establishment Identifier (FEI)

Verify that your FEI and Facility Address are up to date. Any inconsistencies may cause the
submission to be rejected. Establishment Registration & Device Listing
Please select the associated FDA District Office

*

2.2 Auditing Organization Contact Information
Please enter Auditing Organization contact information
Contact Information:
Contact Name
Occupation Title
Email Address
Address
Establishment Name
Address
Telephone Number

Auditing Organization Members
Team Member Name
Is this team member an employee or a contractor to the auditing organization?

Team Member Name
Is this team member an employee or a contractor to the auditing organization?

Team Member Name
Is this team member an employee or a contractor to the auditing organization?

*

Submission Report

Team Member Name
Is this team member an employee or a contractor to the auditing organization?

Team Member Name
Is this team member an employee or a contractor to the auditing organization?

2.3 Applicant Contact Information
Information:

Contact name should be the submitter of this submission.

*

Please enter your contact information
Contact Information:
Contact Name
Occupation Title
Email Address
Address
Establishment Name
Address
Telephone Number

3.0 Submission Content

Enter your product for medical devices manufactured at this establishment.
Product Codes can be entered manually or selected using filters. Click the link for additional
instructions on how to use the Product Code Filters. Product Code Filter Guide
*

Multiple Product Codes may be selected
Item

Product Code

Audit Type

Device

Classification

Class

Panel

C.F.R. Section

*

Submission Report

3.1 Auditing Bodies
Select all that apply.

* [ ] Australia
[ ] Canada
[ ] European Union
[ ] Japan

Auditing Affiliations
Select an auditing body affiliated with Australia.

Select an auditing body affiliated with Canada.

Select an auditing body affiliated with the European Union.

Select an auditing body affiliated with Japan.

4.0 Audit Reports
Information:

Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends
section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 374 (g)(7)).
Section 228 was amended to add the following provision:
(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary
submissions of reports of audits assessing conformance with appropriate quality system standards set
by the International Organization for Standardization (ISO) and identified by the Secretary in public
notice. If the owner or operator of an establishment elects to submit audit reports under this
subparagraph, the owner or operator shall submit all such audit reports with respect to the
establishment during the preceding 2-year periods.

4.1 Most Recent Audit Report
Information:

All documentation and data entered in this section should be associated with the most recent audit
date within 90 days of this submission.

Enter the most recent Audit date within 90 days of this submission.
Attach the original Audit Report.

*
*

Submission Report

Attach the original ISO 13485 certificate

*

Attach any associated correspondence for this Audit Report period.

*

Are all of the above original documents in English?

*

4.2 Preceding Audit Reports and Information
Information:

The following set of Audit Reports with a timeframe of 2 years, should precede the most recent Audit
Report in Section 4.1.

Were Audits conducted in the previous 2 years from the last day of the most recent Audit?

* Yes

Submission Report

Section: Previous Audit Reports

1.0 Preceding Audit Reports and Information
Information:

The following set of Audit Reports with a timeframe of 2 years, should precede the most recent Audit
Report in Section 4.1.

How many Audits were conducted in the previous 2 years from the last day of the most

* 5

recent Audit?

1.1 First Preceding Audit Report
Attach your Previous Audit Reports

*

If the ISO 13485 certificate is different for this Audit Report, please attach the relevant ISO 13485 certificate.

*

Attach any associated correspondence for this Audit Report.

*

Are all of the above original documents in English?

*

1.2 Second Preceding Audit Report
Attach your Previous Audit Reports

*

If the ISO 13485 certificate is different for this Audit Report, please attach the relevant ISO 13485 certificate.

*

Attach any associated correspondence for this Audit Report.

*

Are all of the above original documents in English?

*

1.3 Third Preceding Audit Report
Attach your Previous Audit Reports

*

Submission Report

If the ISO 13485 certificate is different for this Audit Report, please attach the relevant ISO 13485 certificate.

*

Attach any associated correspondence for this Audit Report period.

*
*

Are all of the above documents in English?

1.4 Fourth Preceding Audit Report
Attach your Previous Audit Reports.

*

If the ISO 13485 certificate is different for this Audit Report, please attach the relevant ISO 13485 certificate.

*

Attach any associated correspondence for this Audit Report period.

*
*

Are all of the above documents in English?

1.5 Fifth Preceding Audit Report documents
Attach your Previous Audit Reports

*

If the ISO 13485 certificate is different for this Audit Report, please attach the relevant ISO 13485 certificate.

*

Attach any associated correspondence for this Audit Report period.

*
*

Are all of the above documents in English?

Attestation
Stop:

Any submissions submitted after 90 days from the last day of the Audit will be rejected.

Information:

To the best of my knowledge, the data and information submitted are truthful and accurate, and no
material fact has been omitted.

Full Name
Date of Attestation

*
*