Substantial equivalence FDA law

One of the areas of regulation by the food and Drug Administration's medical devices. All new medical device must be approved or approved by the FDA before it can be marketed. To delete a medical device must demonstrate the substantial equivalence. Approved clearance vs ApprovalNew medical devices or can be authorized by the FDA. If you are completely original device you must be deleted. However, if the device is a change or a new version of an already approved technology, it can be, approved.PurposeThe reference of substantial equivalence is used, to avoid waste of time and resources that a device that has no essential difference from a device already approved for approval. This rationalisation that manufacturer 90 days warn efficient products on the market of faster.RequirementsThe FDA requires to get OEMs prior to the date you intend to market the device. FDA review it and are equivalent, essential if no changes, the function, the safety or efficacy of the device change it.