Medical Device Indications For Use Vs Intended Use

The Difference Between Intended Use …

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 of your device. Indications …

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 = the conditions or …

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 …

General/Specific Intended Use - Guidance for Industry

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

MDR clinical evaluation planning - intended purpose, …

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/mdr-clinical-evaluation-planning-intended-purpose-indications-contraindications/

January 05, 2022. •. Dr. Amie Smirthwaite. The definition of the intended purpose and indications for use of the device is a critical first step which shapes all …

The Difference Between Intended Use, …

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

Your intended use can impact the regulatory pathway that you need to follow, so it is important to be accurate and clear when stating your intended use. 1 Next comes indications for use. …

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 …

Intended Use or Indications for Use? | Regulatory

https://leanraqa.com/intended-use-and-indications-for-use/

The Indications for Use arise from the Intended Use, because you can’t have indications without intention. Setting your intention and indications are the first steps along the path …

Indications for Use vs. Intended Use in User Manual

https://elsmar.com/elsmarqualityforum/threads/indications-for-use-vs-intended-use-in-user-manual.42706/

21 CFR 814.20 (b) (3) (i) Indications for use: “A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a …

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 …