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"FDA Accepted" refers to the 510K process for Medical Devices. Medical devices are generally not "approved" but rather accepted by the FDA. The manufacturer/510K applicant must prove that their device is similar to another device on the market (the "predicate" device) and that it will not cause harm to the patient. The level of proof that must be provided is based upon the classification of the medical device (class 1 = a device that poses little risk to a person such as a toothbrush, an exam light, a dentist's pick, class 3 = anything implanted into the body and/or something that sustains life/prevents loss of life such as an artificial joint or an automated defibrillator).
If there is no "predicate device" (it's a brand new device/technology), then the FDA does "approve" the device and it goes through a stricter review process.
The FDA is currently undergoing a careful review of it's 510K approval process because of all the defective/non-effective devices that the FDA has accepted onto the marketplace.
Alternatively, all drugs (aka prescription pharmaceuticals) go through the "New Drug Application" (NDA) Process and must be formally approved by the FDA to ensure safety, efficacy, and purity of the product. Generic drug applications (ANDAs) must prove that they are biologically/chemically identical to the drug that they are copying.
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