What does it mean when FDA "clears" or "approves" a medical device?
When FDA review is needed prior to marketing a medical device, FDA will either
- "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
- "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.
To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
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