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	RM Materials RM Materials Home Materials Currently Available Materials Needed Reference Material Sources Guidance and Oversight Reference Articles Collaborator Acknowledgements   DLS Content DLS Home CLIA Genetics International MASTER Monitoring MPEP NLTN Publications Training   Other DLS Resources Resource Links RM Materials - Guidance and Oversight American College of Medical Genetics (ACMG) Select Documents General guidance page Standards and Guidelines for Clinical Genetics Laboratories 2006 Edition Technical Standards and Guidelines for CFTR Mutation Testing 2006 Edition Technical Standards for Fragile X 2006 Edition ACMG Fragile X practice guidelines Technical Standards for Huntington Disease 2006 Edition Grody WW, Cutting GR, Klinger KW, Richards CS, Watson MS, Desnick JR. Laboratory standards and guidelines for population-based cystic fibrosis carrier screening. Genet Med 2001;3:149-154. American College of Obstetricians and Gynecologists, and American College of Medical Genetics. Preconception and prenatal carrier screening for cystic fibrosis. Clinical and Laboratory Guidelines. A merican College of Obstetricians and Gynecologists, Washington, DC;2001. Watson MS, Cutting GR, Desnick RJ, et al. Cystic fibrosis population carrier screening: 2004 revision of American College of Medical Genetics mutation panel. Genetics in Medicine 2004;6:387-391.   American College of Obstetricians and Gynecologists (ACOG) ACOG Committee on Genetics. Prenatal and preconceptional carrier screening for genetic diseases in individuals of Eastern European Jewish descent. Obstet. Gynecol. 2004;104:425-428.   Association of Molecular Pathologists (AMP) Association for Molecular Pathology statement. Recommendations for in-house development and operation of molecular diagnostic tests. American Journal of Clinical Pathology. 1999;111(4):449-463.   College of American Pathologists (CAP) Laboratory Accreditation Checklists   CLIA - Clinical Laboratory Improvement Amendments   Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) Selected Documents: MM01-A2 - Molecular Diagnostic Methods for Genetic Diseases MM09-A - Nucleic Acid Sequencing MM12-A - Diagnostic Nucleic Acid Microarrays MM13-A - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods MM14-A - Proficiency Testing (External Quality Assessment) for Molecular Methods MM16-A - Use of External RNA Controls in Gene Expression Assays   Clinical Molecular Genetics Society Best practices guidelines   Eurogentest Eurogentest Unit 1 - Quality Management and Accreditation/Certification of Genetic Testing List of best practice guidelines   European Molecular Genetics Quality Network (EMQN) Best practice guidelines   FDA (Food and Drug Administration) 21 CFR part 862 Clinical Chemistry and Clinical Toxicology Devices Sec. 862.1660 Quality control material (assayed and unassayed) Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material. Draft released for comment on February 3, 1999 Draft Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions. Document issued on: September 7, 2006 Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff. Document issued on April 25, 2006 Draft Guidance for Industry and FDA Staff - Pharmacogenetic Tests and Genetic Tests for Heritable Markers. Document issued on February 9, 2006 Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays. Document issued on September 7, 2006   New York State Clinical Laboratory Evaluation Program (CLEP) Laboratory Standards.   Washington State Medical Test Site Rules (Chapter 246-338 WAC). This page last reviewed: 1/16/2007
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