General Purpose Medical Device

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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

Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …

Intended Purpose Under MDR - What Does Your Medical Device …

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 …

General/Specific Intended Use - Guidance for Industry

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

Purpose The purpose of this document is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific …

Overview of IVD Regulation | FDA

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation

General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments to the FD&C Act, that provide the FDA with the means of …

What are examples of Software as a Medical Device? | FDA

https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device

Software as a Medical Device ranges from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for …

Devices without a medical purpose

https://bioregservices.com/blog/devices-without-a-medical-purpose/

In this article, we explore a newly introduced product category described in Annex XVI of the Regulation (EU) 2017/745 on medical devices (MDR): “Devices …

General Medical Device - an overview | ScienceDirect …

https://www.sciencedirect.com/topics/nursing-and-health-professions/general-medical-device

General medical devices (Class I) are those considered to pose nonsignificant risk and require conformance with a self-declaration system. Designated controlled medical …

Factsheet: medical devices overview

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by …

Examples of Software Functions That Are NOT Medical …

https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-are-not-medical-devices

1 Medical purpose magnifiers are regulated either under 21 CFR 886.5840 - Magnifying spectacles ("devices that consist of spectacle frames with convex lenses …

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