How to Navigate Public Info on FDA’s Website

Medical devices are classified based on the risks associated with the use of the device. Which of the following classes is the lowest risk?

A dental laboratory manufactured product is considered a medical device when there is no drug component.

A Cleared Medical Device is one that has been Approved by FDA.

FDA discounts or waives some of their registration fees for certain small businesses.

FDA has requirements that must be met when importing into the U.S. and exporting outside the U.S.

FDA gives all medical devices a 3-letter product code for classification.

Guidance Documents help to understand how certain devices are regulated.

Medical Device Reporting does not apply to anyone who manufactures Class I and Class II medical devices.

Most dental laboratories are not required to register with FDA.