Non-Fda Medical Devices

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

6 Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the...

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

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Registration and listing. Establishments that are involved in the production and distribution of …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …

Medical Device Regulation for non-medical products

https://www.medicaldevice-network.com/sponsored/medical-device-regulation-non-medical-products/

Medical Device Regulation for non-medical products Contact lenses, dermal fillers, machines for laser treatment for body hair removal… all products without …

Is it illegal for a consumer to obtain or use a non-FDA …

https://law.stackexchange.com/questions/18948/is-it-illegal-for-a-consumer-to-obtain-or-use-a-non-fda-approved-medical-device

Freestyle Libre Pro is a continuous glucose monitoring (CGM) system designed to provide a clear, visual snapshot of a patient's glucose levels, trends and patterns for up to 14 days …

Non-Invasive Body Contouring Technologies | FDA

https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies

Some non-invasive body contouring devices are designed to achieve your desired effect by decreasing small amounts of excess fat in the treated body area. This …

Augmented Reality and Virtual Reality in Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices

The FDA is providing this list of medical devices that incorporate AR/VR marketed in the United States as a resource to the public about these devices and the …