Editing Food and Drug Administration (section)

===="FDA-Cleared" vs "FDA-Approved"====
Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm |title=What does it mean when FDA "clears" or "approves" a medical device? |publisher=Food and Drug Administration |access-date=March 14, 2015 |archive-date=March 7, 2015 |archive-url=https://web.archive.org/web/20150307000034/http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm |url-status=dead}}</ref>