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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | | In order to remain commercially viable - Personalized Medicine Programs providing omics testing services must use appropriate regulatory approved & validated omic testing devices whether results are used to evaluate tumor response, diagnose & treat, evaluate drug response, bioavalibility or biomimetic characteristics.
This means omic medical device manufacturing facilities must adhere to strict quality regulations & GxP manufacturing best practices.
In the US Omics medical devices & accompanying equipment are regulated by the FDA. This resource page will be dedicated to identifying & listing
Global Medical Omics Device Regulations, Requirements, Standards & Best Practices not only for the devices themselves, but for the collection, data storage & reporting of patient omic data.
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November 2012 CDC Work Group publishes guidelines for NGS clinical tests. Access Here
FDA Small Entity Compliance Guide "Medical Device Quality Systems Manual" Supersedes the "Medical Device Good Manufacturing Practices GMP Manual"
September 2012 - Current FDA Medical Device PostMarket Surveillance System Access Here
FDA Comprehensive Medical Device Regulatory Assistance
What Organizations or Programs are Implementing Proficiency Testing Programs for Omics Testing & What Standards have these Programs Established?
Under CLIA, each laboratory performing nonwaived omics testing must enroll in one CMS approved proficiency testing program for each specialty, subspecialty, and analyte specified in Subpart I of the CLIA regulations. Molecular testing laboratories are still required to participate in equivalent activity such as exchanges of materials with other laboratories. Refer to relevant
sections in CLIA 42 CFR 493.1236(c)
The College of American Pathologists (CAP) and the American College of Medical Genetics (ACMG) jointly administer a proficiency testing scheme.
FDA Recognized Consensus Standards Organization
AU
2012 First Edition - Australian Government Department of Health: Requirements for Medical Testing of Human Nucleic Acids Access Here
AU Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis
Access Here
National Association of Testing Authorities Australia 2012
Technical Note - Guidelines for the validation and verification of
quantitative and qualitative test methods Access Here
AU National Accreditation Advisory Council Requirements for Medial Microbial Nucleic Acid Testing Access Here
AU National Pathology Accreditation Advisory Council Requirements for the Performance Anatomical Pathology Cut-up Access Here
AU National Pathology Accreditation Advisory Council Guidelines for Approved Pathology Collection Centres Access Here
Switzerland
Best Practice Guidelines on reporting Molecular Genetic Diagnostic laboratories in Switzerland Swiss Society of Medical Genetics Access Here
US
FDA Draft Guidance NOV 2012 for Review & Comment. CBER & OCTGT Preclinical assessment of investigational cellular & gene therapy products. Access Here
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