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FDA Clarifies Device Special Controls Guidance

03/28/2011

Federal Register Notice: FDA is making available updated special controls guidance documents for Class 2 devices, containing edits in an effort to clarify questions and confusion about the agency’s position on the binding nature of special controls guidance documents. The revised language does not FDA’s position or view, but rather is intended to clarify its position and remedy any possible confusion or misunderstanding. To view this notice, click here.

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