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U.S. Department of Health and Human Services

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Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

A domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation, is eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Pilot Program under the following circumstances

1. The audit report is submitted to the FDA within 90 days from the last day of the most recent ISO 13485:2003 audit;

2. The audit is performed using ISO 13485:2003: “Medical devices - Quality management systems – Requirements for regulatory purposes ;” and,

3. The audit was performed by an auditor under one of the GHTF founding members regulatory systems:

a. The Canadian Medical Devices Conformity Assessment System (CMDCAS);

b. The European Union medical device Notified Body system;

c. The Therapeutics Goods Administration of Australia, Office of Manufacturing Quality; or

d. The Japanese Ministry of Health, Labour and Welfare system for Medical Devices and In-vitro Diagnostics.

4. The most recent eligible ISO 13485:2003 audit and the resulting audit report that satisfy the GHTF Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers.

a. Part 1: General Requirements Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers;

b. Part 2: Regulatory Auditing Strategy Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers; and

c. Part 3: Regulatory Audit Reports.

5. The most recent eligible ISO 13485:2003 audit report submitted will also need to be consistent with HC’s GD211: Guidance on the content of quality management system audit reports. GD211 is based on the work of Study Group 4 of the GHTF, and in particular on the technical content of GHTF document SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

ISO 13485:2003 Voluntary Audit Reports are packaged for submission to FDA using the FDA eSubmitter software and are submitted using FDA’s Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions. The ESG routes electronic submissions to CDRH and will provide three acknowledgements indicating the status of the submission at various stages of the submission’s transmission to CDRH. 

An account is required to use the ESG, and there are a number of steps needed to set up an account. Information on how to establish an account and information on various aspects of using the ESG may be found on the Electronic Submissions Gateway Website. Upon completion of the required ESG new-account activities, and successful transmission of a test submission, an ESG account will be granted and the ISO 13485:2003 Voluntary Audit Report can be submitted to FDA.

 

 

If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the the Contact Us page.