FDA Regulation of Medical Devices

“Approved medical devices: Approved medical devices are those devices for which FDA has approved a premarket approval (PMA) application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a more rigorous premarket review than the 510(k) pathway.”

–PMA database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

“Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.”

–510(k) Premarket Notification database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

The above quotes are from http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm.

Waived tests: “Diagnostic tests are categorized as waived based on the premise that they are simple to use, and there is little chance the test will provide wrong information or cause harm if it is done incorrectly. Tests that are cleared by the FDA for home or over-the-counter use are automatically assigned a waived categorization.”

–CLIA database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm

The above quote is from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393229.htm.