Definition Of Intended Use Of A Medical Device

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

General/Specific Intended Use - Guidance for Industry

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

A change from a general to a specific indication for use is defined as: Any proposed increase in the level of specificity of the indication for use of a medical device. A change …

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 …

Intended Use and the Usage According to …

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

The term intended use includes medical devices, strictly speaking in two aspects: The actual medical purpose, that is, which disease or injury you can diagnose, treat or …

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 Purpose Under MDR - What Does Your …

https://decomplix.com/intended-purpose-medical-device/

The manufacturer of a medical device is responsible for defining the intended purpose of the device, which has far-reaching consequences: the first is the basis of the …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a …

Intended use and Indications of use of Medical Device

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

Intended Use is generally the what the manufacturer label claims for what the medical device is used for. Indication of Use generally describes the reasons or the …

Intended purpose – The European Union Medical Device …

https://eumdr.com/intended-purpose/

Intended purpose is defined in Article 2 (12): “ ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in …

Step 1: Decide the intended use and classification

https://eumdr.com/step-1/

Step 1: Decide the intended use and classification – The European Union Medical Device Regulation Step 1: Decide the intended use and classification Consider …