Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration
FDA source page describing its voluntary pilot program for selected oncology drugs used with in vitro diagnostic tests; participation and current status must be checked with FDA.
Fuente: fda.gov · Consultado el 2026-10-19
Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
Technical guidanceU.S. Food and Drug Administration
FDA guidance on development and labeling considerations for companion diagnostics intended to support a group of oncology therapeutic products.
Fuente: fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration
FDA special controls source document covering RNA specimen collection, stabilization and purification systems for molecular diagnostic RT-PCR.
Fuente: fda.gov · Consultado el 2026-10-19
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
Technical guidanceU.S. Food and Drug Administration
FDA question-and-answer guidance about commercially distributed analyte specific reagents. Consult the original document and current FDA notices for applicable requirements.
Fuente: fda.gov · Consultado el 2026-10-19
In Vitro Companion Diagnostic Devices
Technical guidanceU.S. Food and Drug Administration
FDA guidance page for developers of therapeutic products and corresponding in vitro companion diagnostic devices.
Fuente: fda.gov · Consultado el 2026-10-19
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
Technical guidanceU.S. Food and Drug Administration
FDA source document on reporting diagnostic test study results, including the choice of comparison standard and measures of test performance.
Fuente: fda.gov · Consultado el 2026-10-19
In vitro diagnostic medical devices: guidance on legislation
Technical guidanceMHRA / Department of Health and Social Care (GOV.UK)
What Great Britain actually requires of IVD sale and supply, under Part IV of UK MDR 2002.
Fuente: gov.uk · Consultado el 2026-10-30
A harmonised real-time PCR protocol for diagnosing Bordetella infections, with the reasoning behind it.
Fuente: ecdc.europa.eu · Consultado el 2026-10-30
Pathway to Quality-Focused Testing
Technical guidanceCDC Division of Laboratory Systems with APHL
A validation and continued-testing framework for NGS workflows, with a fillable checklist.
Fuente: cdc.gov · Consultado el 2026-10-30
The Next Generation Sequencing Quality Initiative
Technical guidanceCDC Division of Laboratory Systems with APHL
A free library of sequencing quality guidance and SOPs built on CLSI’s quality-systems framework.
Fuente: cdc.gov · Consultado el 2026-10-30
Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions
Technical guidanceCDC (CLIAC via MMWR)
The CLIAC good-laboratory-practice recommendations for molecular genetic testing, published in MMWR.
Fuente: cdc.gov · Consultado el 2026-10-05
Emergency Use Listing Procedure
Technical guidanceWHO Regulation and Prequalification
The risk-based listing procedure for diagnostics not yet under stringent regulatory assessment.
Fuente: extranet.who.int · Consultado el 2026-10-30
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.