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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

Is Your Product Regulated? | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/your-product-regulated
    The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act. The FD&C Act contains …

How Do I Determine if my Product is a Medical …

    https://www.greenlight.guru/blog/is-my-product-a-medical-device
    A product that might be a medical device becomes one when the feature set evolves enough so that it can adequately be described as a medical device under that definition. That’s a …

Is My Product a Medical Device? - Food and Drug …

    https://www.fda.gov/media/131268/download
    Identifying an existing medical device product classificationcan be helpful Consider further assistanceif necessary Resources Resources Resources Providing …

Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - …

Importing Medical Devices | FDA

    https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
    To assist you in determining if your product is a medical device, you may visit the “Is the Product a Medical Device?” page. Additionally, the Federal Food, Drug, and Cosmetic …

Is My Product a Medical Device? Medical …

    https://decomplix.com/product-medical-device-ce-mark-eu/
    How to determine if your product requires medical device CE marking. If you want to know whether your product is considered a medical device (or an in vitro diagnostic device, IVD) …

Determining if your Product is a Medical …

    https://emmainternational.com/determining-if-your-product-is-a-medical-device/
    Section 201 (h) of the Food, Drug, and Cosmetic act lays out explicitly what is legally considered a device; put simply, a medical device is any product that diagnoses, treats, or prevents a …

Is my product a medical device? | Therapeutic Goods …

    https://www.tga.gov.au/resources/my-product-medical-device
    It would appear your product might not be a medical device as you have indicated that it does not have an intended use as a medical device. If your product is already included in …

Is my Product a Medical Device? - Red Elephant Data Services

    https://udiregulation.com/is-my-product-a-medical-device/
    an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which …



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