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FDA accredits Wadsworth Center as a 3rd party reviewer
Tuesday, June 27, 2017
FDA accredits Wadsworth Center as a 3rd party reviewer for selected premarket notifications or 510(k)s, which allows the Center to review, on FDA’s behalf, certain devices that fall under this classification.
This accreditation represents the recognition of the expertise acquired by the Center’s staff from reviewing laboratory developed tests as part of New York’s Clinical Laboratory Reference System.
Over the next few months the Center’s reviewers will undergo additional training to familiarize themselves with the FDA’s process. At the same time the Center will define criteria determining which device applications are eligible for the process.
It is expected that these initiation procedures will be completed by this fall.