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This document presents current approaches and concerns regarding over-the-counter hCG devices. It is based on: 1) current science; 2) clinical experience; 3) previous submissions by manufacturers to the Food and Drug Administration (FDA); 4) the FDA Modernization Act of 1997 (FDAMA); and 5) FDA regulations in the Code of Federal Regulations (CFR). As advances are made in science and technology, and as changes in implementation of legislation occur, these Review Criteria will be re-evaluated and revised as appropriate. So that the draft may be revised as necessary, please send comments as instructed in the Preface.