Glossary

A 510(k) device refers to a device classified under Section 510(k) of the United States Food, Drug, and Cosmetic Act (a.k.a. Premarket Notification).  A device that reaches market via a 510(k) notification must be "substantially equivalent" to a predicate device on the market.  A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.

An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. (Source: Drugs@FDA Glossary of Terms)