FDA Seeks Comment on Draft Guidance for Industry, Third Parties and FDA Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program

May 24, 2010   

This week, United States Food and Drug Administration announced that a new draft guidance, “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” is available for public review and comment.  This new FDA program allows for a medical device manufacturer whose facility is inspected and audited by any of the Global Harmonization Task Force (GHTF) approved systems, like the Canadian Medical Devices Conformity Assessment System or European Union Notified Body, to voluntarily submit the results of that audit to the FDA.  The FDA will then utilize the results of that audit in its risk-based analysis of whether it can remove the firm from its work plan for the next year.  In other words, the FDA will use the audit conducted by the other accredited body to make decisions about which firms it will inspect during the upcoming year.  The Agency will base its decisions on the probability of risk reported in the audit and the type of device manufactured by the firm.  This is a way in which a compliant device manufacturer already audited through another recognized system may avoid an inspection by FDA.  The program benefits FDA, as well, as the program allows the Agency to use its resources to focus on auditing firms that require more oversight.

The International Organization for Standardization (ISO) is a group with representatives from various national standards organizations that promulgates worldwide proprietary industrial and commercial standards.  The medical device ISO 13485:2003 provides quality management system requirements for medical device manufacturers and distributors.  Under this ISO, a firm must demonstrate that it can produce medical devices and related services that are consistently compliant with the regulatory requirements set forth by ISO. The FDA, through the new draft guidance, will use the medical device ISO 13485:2003 to leverage audits performed by other GHTF regulators to assist the Agency in setting risk-based inspectional priorities.

The FDA is utilizing inspections and audits conducted by third parties and other regulators with increasing frequency.  The Agency is employing reliable reports from other regulatory bodies to establish a more efficient work plan.  Under the Medical Device User Fee Modernization Act of 2002 (MDUFMA), the FDA is authorized to train and accredit third parties to perform inspections of eligible establishments that manufacture Class II or Class III devices.  This voluntary program is known as the Accredited Persons AP for Inspections program.  While all firms remain subject to inspection by FDA, eligible manufacturers have the option of requesting inspection by an AP.  Additionally, in 2006, the FDA and Health Canada (HC) announced a pilot multi-purpose audit program (PMAP) allowing qualified accredited persons and auditing organizations under the AP for Inspections program and HCs equivalent program, the Third Party Auditing Organizations, to perform a single inspection that both FDA and HC can use.  The purpose of this pilot program is to evaluate the effectiveness of performing one third party inspection of a medical device firms quality system that would meet the regulatory requirements of both countries.  The pilot PMAP and FDAs new draft guidance evidence the Agencys movement toward recognizing the necessity of comity between international regulatory bodies regarding medical device firm inspections and audits.

Fuerst Ittleman, PL is experienced in handling the compliance matters of medical device manufacturers and distributors.  We also assist pharmaceutical and biotechnology firms with regulatory compliance and import/export requirements.  Please feel free to contact us at contact@fidjlaw.com to discover how we can help your company with medical device manufacture, inspections, importation/exportation, and distribution.

See 75 FR 28257.