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Key Issues to Consider about Communication and Memory

Are there potential safety issues I should consider?

Many of the products listed on this website are considered medical devices, and are regulated by the FDA. Products that are not medical devices are regulated by the Consumer Product Safety Division. Note: Assistive technology devices and over-the-counter products may also be a medical device. A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease. Medical devices can be anything from thermometers to artificial hearts to at- home pregnancy test kits.” (source: Federal Food, Drug and Cosmetic Act, Section 201).

    For more information on whether a product is a medical device, please refer to the following government websites (cut and paste URL into your browser window):
    Is this product a Medical Device? http://www.fda.gov/cdrh/devadvice/312.html
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm
    For information on product recalls and mis-branding of devices, see:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/RESSimpleSearch.cfm
    http://www.recalls.gov/
    http://www.fda.gov/cdrh/devadvice/3315.html


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