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# 3 Internatl. Device Reg. Documents Released by FDA
- URL: https://www.fdaweb.com/3-internatl-device-reg-documents-released-by-fda/
- Published: 2018-11-14T12:00:00.000Z
- Updated: 2026-09-15T00:44:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142816

FDA has released three documents produced by the International Medical Device Regulators Forum, of which the agency is a member. *Optimizing Standards for Regulatory Use* says that standards play a significant role in the design, production, post-production, and regulation of medical devices throughout their lifecycle. “Standards offer a means to streamline and harmonize regulatory processes around the world, especially as medical devices grow in complexity and international markets expand,” the [document](http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181105-optimizing-standards-n51.pdf?ref=fdaweb.com) says. Included are an Introduction, Scope, Definitions, General, Recommendations for Standards Development, Enhancing Stakeholder Participation in Standards Development, and IMDRF and Standards Development.

The second [document](http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf?ref=fdaweb.com), *Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices*, is intended to provide harmonized essential principles “that should be fulfilled in the design and manufacturing of medical devices and IVD medical devices to ensure that they are safe and perform as intended. The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to regulatory authorities.” Its sections include Introduction, Scope, References, Definitions, Safety and Performance of Medical Devices—General Essential Principles, Essential Principles Applicable to All Medical Devices and IVD Medical Devices, Essential Principles Applicable to Medical Devices Other Than IVD Medical Devices, and Essential Principles Applicable to IVD Medical Devices.

The third [document](http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181018-pmd-definitions-n49.pdf?ref=fdaweb.com), *Definitions for Personalized Medical Devices*, is intended to establish harmonized definitions that are used to describe medical devices intended for a particular individual. The document applies to all medical devices and is intended to identify and describe different categories of devices that are produced for the use of a particular individual, and also to define some other items that are relevant to defining these types of devices. It contains an Introduction, Scope, References, and Definitions.