Medical Device Intended Use And Indications For Use

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General/Specific Intended Use - Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry

This guidance1 document identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is reasonably included within a general indication for use of a medical device2for purposes of determining substantial equivalence … See more

The Difference Between Intended Use and …

https://www.greenlight.guru/blog/intended-use-and-indications-of-use

In a nutshell, the definitions for intended use and indications are as follows: Intended use is what you claim on your label that the device does. It’s the purpose …

Device Description and Indications for Use …

https://www.fda.gov/media/141274/download

Intended Use Defined as the general purpose of the device or its function, and encompasses the indications for use. Indications for Use Defined in 21 CFR …

The Difference Between 'Intended Use' and …

https://www.mddionline.com/human-factors/why-you-must-know-difference-between-intended-use-and-indications-use

Intended use = what you say on the label that the device is to be used for. Indications of use = …

Intended Purpose, Intended Use, and Indications for Use | Clin R

https://clin-r.com/intended-purpose-intended-use-and-indications-for-use/

Indications It is important to note that not all devices have indications, as clarified by the definition of ‘indication’ in MDCG 2020-6: ‘indication’, ‘indication for use’: refers to the …

Intended Purpose, Intended Use, and Indications for Use

https://www.linkedin.com/pulse/intended-purpose-use-indications-clin-r

‘indication’, ‘indication for use’: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, …

The Difference Between Intended Use, …

https://emmainternational.com/the-difference-between-intended-use-indications-for-use-and-instructions-for-use/

The FDA defines intended use as, “the objective of the persons legally responsible for the labeling of devices”. Put in simpler terms, the intended use is what …

Determination of Intended Use for 510(k) Devices Guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determination-intended-use-510k-devices-guidance-cdrh-staff-update-k98-1

As stipulated in Section 513 (i) of the Act, FDA may issue an order of substantial equivalence only upon making the determination that the device to be introduced into …

Intended Use and the Usage According to …

https://www.johner-institute.com/articles/product-development/intended-use-description/

Intended Use and the Usage According to Regulations Intended Use (check out also GHTF/SG1/N70:2011) is an objective aim of medical products manufacturers related …

Intended use and Indications of use of Medical Device

https://www.i3cglobal.com/intended-use-and-indications-of-use-of-medical-device/

Indication of Use generally describes the reasons or the situations or the diseases for which the medical device is used to fulfill its intended use. It also gives the …

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