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Guidance on the Recognition and Use of Consensus Standards

General Program Guidance #G98-2 (FDAMA)

Director
Office of Device Evaluation (HFZ­400)

Guidance on the Recognition and Use of Consensus Standards

ODE Review Staff

Purpose

The purpose of this guidance document is to provide guidance to ODE reviewers and industry on the recognition and use of national and international consensus standards, including declarations of conformity to these standards, during the evaluation of premarket submissions for medical devices.

Guidance

The attached "Guidance on the Recognition and Use of Consensus Standards" and the accompanying attachments were published on February 19, 1998. This guidance sets forth the background, procedures for use, and limitations on consensus standards.

Effective Date: February 19, 1998.