The International Medical Device Regulators Forum (IMDRF)—a global coalition of medical device regulators working to harmonize regulatory approaches—is seeking comments on a consultation document from its Standards Working Group.
The consultation document, “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.
Chaired by Scott Colburn of the U.S. Food and Drug Administration, the IMDRF Standards Working Group has drafted this guidance as part of its efforts to improve globally relevant standards for regulatory use and, in turn, foster harmonization.
The guidance 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.
Interested parties are encouraged to submit comment to firstname.lastname@example.org by May 24.