Selling Medical Devices Without Fda Approval

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FDA Clearance vs. FDA Approval Process for Medical …

https://www.goodrx.com/healthcare-access/medication-education/fda-approval-vs-fda-clearance

In short, no. In order to market or sell a medical device, it must be registered, cleared, or approved by the FDA. In 1976, Congress amendedthe Federal Food, Drug, and Cosmetic Act to allow the FDA to regulate medical devices before they’re legally sold in the US. This was done to ensure safety and … See more

FDA's Role in Regulating Medical Devices | FDA

https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices

Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must …

Importing and Exporting Medical Devices | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/importing-and-exporting-medical-devices

A device that has not been approved, cleared, or otherwise exempted from pre-market notification requirements for marketing in the United States must follow the …

Reporting Unlawful Sales of Medical Products on the …

https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet

What NOT to report on this form: For emergencies call 9-1-1 immediately. If your report involves a limited emergency situation (which is urgent but not life …

How to Study and Market Your Device | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device

If your product is a combination product - a medical device plus another FDA-regulated product (e.g. drug, biologics, etc.), you should contact FDA’s Office of …

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