ANSI - American National Standards Institute
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International Medical Device Regulators Seek Input on Proposed Guidance for Optimizing Standards for Regulatory Use


04/16/2018

The International Medical Device Regulators Forum (IMDRF), a global coalition of medical device regulators working to harmonize regulatory approaches globally, is seeking comments on a newly released consultation document from its Standards Working Group. “Optimizing Standards for Regulatory Use” is intended to serve as an educational resource for regulators, standards developers, and other interested stakeholders to ensure that consensus standards are useful for the regulatory oversight of medical devices. IMDRF’s deadline for submission of input is May 24, 2018.

The IMDRF Standards Working Group, chaired by Scott Colburn of the U.S. Food and Drug Administration (FDA), has drafted this guidance as part of its efforts to improve globally relevant standards for regulatory use and, in turn, foster harmonization. It recommends best practices for the standards development process, including effective regulatory authority participation, in order to advance the use of standards for regulatory purposes around the world.

Input should be submitted to the FDA’s Gail M. Rodriguez, Ph.D., at gail.rodriguez@fda.hhs.gov using this comment form by the May 24 deadline.

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