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FDA addresses consensus standards

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 3, 2007

In three documents, the FDA offers guidance on the use of consensus standards, which are used during review of pre-market submissions for medical devices to help determine the safety and effectiveness of the devices.

A summary of these documents follows.

Guidance on use of standards

In the guidance document "Recognition and Use of Consensus Standards," the FDA addresses use of national and international consensus standards and declarations of conformity with those standards. The FDA states the guidance doesn't affect the Center for Devices and Radiological Health's "ability to obtain any information authorized by the statute or regulations."

The guidance explains that information about how a device conforms to consensus standards should directly affect safety and effectiveness determinations made in review of the following pre-market submissions:

• pre-market notifications (510(k))
• investigational device exemption applications
• pre-market approval applications
• humanitarian device exemption applications
• product development protocols

According to the FDA, including declarations of conformity to consensus standards in a pre-market submission "should, in many cases, eliminate the need to review the actual test data for those aspects of the device addressed by the standards."

However, the guidance notes that conformance with recognized consensus standards is voluntary and medical device manufacturers can chose to address safety and effectiveness in other ways.

The guidance explains how manufacturers can use a declaration of conformity to demonstrate how a device conforms to recognized consensus standards. The guidance lists seven items the declaration of conformity should include such as:

• identification of the relevant consensus standard
• description of ways the standard may have been adapted for the device reviewed
• description of deviations from the standard
• identification of the laboratory or certification body determining conformance of the device with standards

Finally, the guidance also addresses FDA requests for more information in support of a pre-market submission, limitations of consensus standards, and manufacturers' use of a consensus standard even though their device isn't listed in the standard's supplemental information sheet.

Click here to view the guidance.

Answers to questions about standards

The FDA provided "Frequently Asked Questions on Recognition of Consensus Standards" and promised to update the document periodically as industry use of standards increases and more questions arise. In this guidance document, the FDA answers 16 questions about the use of consensus standards in pre-market submissions.

Questions are grouped into categories addressing the declaration of conformity, changes to consensus standards, false declarations, inspections, and standards recognition procedures.

Click here to review the standards on the FDA's Web site.

Guidance on standard recognition

In a third guidance document, the FDA addressed how consensus standards are recognized. The guidance set procedures for the Center for Devices and Radiological Health (CDRH) to identify and evaluate consensus standards. The guidance describes the roles of various managers, supervisors, and other staff within CDRH; how they identify candidate standards; and how the agency reviews outside proposals for recognition of standards.

Click here to review this guidance.

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