Medical Device Intended Use Document

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General/Specific Intended Use - Guidance for Industry | FDA

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 … See more

Template: Intended Use (for Medical Devices Under MDD / …

https://openregulatory.com/intended-use-medical-devices-mdd-mdr-template/

Feb 10, 2023 · Intended Medical Indication. Describe the condition (s) and/or disease (s) to be screened, monitored, treated, diagnosed, or prevented by your software. Importantly, …

Frequently Asked Questions About Medical Devices

https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf

Oct 8, 2018 · This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, ... • intended for use in the diagnosis of disease or …

Intended Use and the Usage …

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 monitor. …

Writing An Intended Use for Software as a Medical Device

https://openregulatory.com/intended-use-software-medical-device/

Feb 10, 2023 · The Intended Use is the most important document, ever, if you want to certify your software as a medical device. Why? It states what your software does and in which …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Jan 25, 2023 · High-risk medical devices (updated) Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must …

The Difference Between Intended Use …

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

Dec 2, 2022 · In other words, your intended use is what the device is used for, and indications for use include where, when, and how it will be used. What are the implications …

GHTF SG1 - Label and Instructions for Use for Medical …

https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n70-2011-label-instruction-use-medical-devices-110916.pdf

Dec 1, 2021 · Label and Instructions for Use for Medical Devices Study Group 1 Final Document GHTF/SG1/N70:2011 September 16th, 2011 Page 3 of 17 . Preface The …

Intended purpose – The European Union Medical Device …

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

It should be written for the intended user group, medical professional or patient, using appropriate medical language. The intended purpose is usually a short statement of two …

Intended Purpose Under MDR - What Does Your Medical …

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

Feb 4, 2020 · The MDR defines the intended purpose in Article 2 (12) as follows: ‘Intended purpose’ means the use for which a device is intended according to the data supplied by …

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