Medical Devices

Office of In Vitro Diagnostics and Radiological Health Final Guidance

This page lists final guidance documents developed by CDRH’s Office of In Vitro Diagnostics and Radiological Health. For a list of current draft guidance documents, please see the Draft Guidance page.

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Note that the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has been reorganized as the Office of In Vitro Diagnostics and Radiological Health (OIR).

OIR (formerly OIVD) Final Guidance Documents

TitleOrganizationDoc #Date
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 579KB) OIR/DMGP/MPCB, OSEL 1400053 04/20/16
Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 514KB) OIR/DMGPD 1400045 04/18/16
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays - Guidance for Industry and Food and Drug Administration Staff (PDF - 130KB) OIR/DCTD 1654 02/09/16
Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration Staff (PDF - 718KB) OIR/DMD 1500014 11/02/15
Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile - Guideline for Industry and Food and Drug Administration Staff (PDF - 740KB) OIR/DMD 120022 08/27/15
Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff (PDF - 534KB) CDRH/OIR 1100491 08/04/15
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 330KB) OIR/DMGP/MGB 1400030 06/17/15
Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures - Guideline for Industry and Food and Drug Administration Staff (PDF - 695KB) OIR/DMD 1400051 05/27/15
Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) - Guidance for Industry and Food and Drug Administration Staff (PDF - 103KB) OIR 1400056 02/18/15
Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff (PDF - 59KB) OIR/DRH/MREPB 1810 12/19/14
Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF) (PDF - 425KB) CDRH/OIR CBER 1763 11/12/14
Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff (PDF - 266KB) OIR/DMD 1400019 10/22/14
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) CDRH/ODE CDRH/OIR CBER 1825 10/02/14
Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis - Guideline for Industry and Food and Drug Administration Staff (PDF - 142KB) OIR/DIHD 1200031 09/18/14
Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents - Guideline for Industry and Food and Drug Administration Staff (PDF - 199KB) OIR/DMD 1200027 09/10/14
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 799KB) OIR/DMD 1803 08/27/14
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DRH 793 06/20/14
Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff OIR/DMD 100496 05/30/14
Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff CDRH/OIR 1788 05/30/14
Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff OIR 1143 03/12/14
Class II Special Controls Guideline: John Cunningham Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff OIR/DMD 1790 01/24/14
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1723 11/25/13
Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB) CDRH/OIR, CBER 1660 04/25/13
Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi OIR 1721 03/28/13
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (PDF - 525KB) CDRH CBER 1797 12/03/15
Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions OSEL/DIAM OIVD/DRD 1698 07/03/12
Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions OSEL/DIAM OIVD/DRD 1697 07/03/12
Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 727KB) ODE OIVD 1772 03/28/12
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System OSEL/DIAM OIVD/DRD 1616 03/27/12
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological Reagents OIVD/DMD 1767 03/09/12
Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices CDRH/OIVD 1752 12/20/11
Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses OIVD/DMD 1740 11/28/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays (PDF - 102KB) OIR/DMD 1713 08/09/11
Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses OIVD/DMD 1638 07/15/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System OIVD/DIHD 1707 03/23/11
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB) CBER CDRH/OIVD 1587 06/25/10
Guidance for Industry and FDA Staff - In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency OIVD 1706 11/06/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems OIVD/DCTD 1686 10/21/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays OIVD/DMD 1672 10/09/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays OIVD/DMD 1673 10/09/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay OIVD/DMD 1669 10/09/09
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems OIVD/DMD 631 08/28/09
Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions OIVD/DIHD 848 01/22/09
Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA OIVD/DMD 1665 01/02/09
Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays OIVD/DMD 1646 05/20/08
Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices OIVD 1171 01/30/08
The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations OIVD OC 1566 01/08/08
Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions CBER CDRH/OIVD 1590 09/14/07
Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers CBER CDER CDRH 1549 02/09/06
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material OIVD 2231 06/07/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis OIVD/DIHD 1627 05/09/07
In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff OIVD/DMD 1594 05/01/07
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests OSB/DB 1620 03/13/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays OIVD/DIHD 1614 01/10/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems OIVD/DIHD 1599 07/27/06
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable CBER CDRH 1588 04/25/06
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses OIVD/DMD 1596 03/22/06
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays OIVD/DMD 1536 02/09/06
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems OIVD/DIHD 1564 10/26/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: AFP-L3 Immunological Test Systems OIVD/DIHD 1570 10/04/05
Guidance for Industry - Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays OIVD/DCTD 1246 09/22/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing) OIVD/DIHD 1563 08/25/05
Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s OIVD ODE 1567 08/12/05
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices CBER CDRH/ODE CDRH/OIVD 337 05/11/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems OIVD/DIHD 1550 03/23/05
Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems - Guidance for Industry and FDA Staff OIVD/DCTD 1546 03/10/05
Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System - Guidance for Industry and FDA Staff OIVD/DCTD 1551 03/10/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry OIVD/DCTD 1301 11/24/04
Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Sirolimus Test Systems OIVD/DCTD 1300 09/30/04
Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications OIVD ODE 2237 09/28/04
Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan OIVD/DMD 1824 09/23/04
Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Guidance for Industry and FDA Staff OIVD/DIHD 1531 05/11/04
Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff OIVD/DIHD 1236 03/16/04
Guidance for Industry and FDA Staff; Replacement Reagent and Instrument Family Policy OIVD 950 12/11/03
Class II Special Controls Guidance Document: Endotoxin Assay - Guidance for Industry and FDA Staff OIVD/DMD 1222 10/31/03
Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Guidance for Industry and FDA Staff OIVD/DMD 1206 10/30/03
Class II Special Controls Guidance Document: Breath Nitric Oxide Test System - Guidance for Industry and FDA Staff OIVD/DCTD 1211 07/07/03
510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff OIVD/DIHD 1223 06/19/03
Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1) OIVD ODE 857 12/03/02
Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA OIVD/DCTD 1380 09/16/02
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties OIR 1160 02/02/01
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA OIVD/DIHD 1184 12/04/01
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers OIVD/DCTD 1072 11/30/00
Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications - Guidance for Industry and FDA Reviewers OIVD/DIHD 1183 08/23/00
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff OIVD/DCTD 1172 07/22/00
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF Only) (PDF - 29KB) OIVD/DCTD 1359 12/21/99
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final Guidance for Industry and FDA Reviewers/Staff OIVD/DIHD 2242 04/27/99
Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final Guidance for Industry OIVD 1247 02/22/99
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Final Guidance for Industry OIVD/DCTD 1102 07/06/98
In Vitro Diagnostic Chloride Test System; Final Guidance for Industry OIVD/DCTD 1103 07/06/98
In Vitro Diagnostic Potassium Test System; Final Guidance for Industry OIVD/DCTD 1107 07/06/98
In Vitro Diagnostic Sodium Test System; Final Guidance for Industry OIVD/DCTD 1109 07/06/98
In Vitro Diagnostic Urea Nitrogen Test System; Final Guidance for Industry OIVD/DCTD 1110 07/06/98
In Vitro Diagnostic Glucose Test System; Final Guidance for Industry OIVD/DCTD 1105 07/06/98
In Vitro Diagnostic Creatinine Test System; Final Guidance for Industry OIVD/DCTD 1104 07/06/98
Guidance for Submission of Immunohistochemistry Applications to the FDA; Final Guidance for Industry OIVD/DIHD 364 06/03/98
Review Criteria For Assessment Of Rheumatoid Factor (Rf) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (Eia), Enzyme Linked Immunosorbent Assay (Elisa), Particle Agglutination Tests, And Laser And Rate Nephelometry OIVD/DIHD 165 02/21/97
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) OIVD/DCTD 1345 11/06/96
Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs (PDF Only) (PDF - 289KB) OIVD/DMD 1631 10/30/96
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA OIVD/DIHD 957 09/19/96
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery (PDF Only) (PDF - 439KB) OIVD/DCTD 122 02/20/96
Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) OIVD/DIHD 980 02/15/96
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 (PDF Only) (PDF - 318KB) OIVD 553 03/14/96
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory and Home Use OIVD/DCTD 605 07/13/95
Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance (PDF Only) (PDF - 564KB) OIVD 95 09/26/94
Points to Consider for Cervical Cytology Devices (PDF Only) (PDF - 661KB) OIVD/DIHD 968 07/25/94
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies (PDF Only) (PDF - 1.4MB) OIVD/DIHD 459 07/15/94
Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) OIVD/DIHD 51 02/01/94
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori (PDF Only) (PDF - 794KB) OIVD/DMD 588 09/17/92
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents (PDF - 939KB) OIVD/DIHD 527 08/01/92
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 (PDF Only) (PDF - 698KB) OIVD/DMD 770 05/15/92
Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe (PDF Only) (PDF - 560KB) OIVD/DMD 554 12/30/91
Review Criteria for Assessment of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin In Vitro Diagnostic Devices (Text Only) OIVD/DIHD 658 09/30/91
Review Criteria for Blood Culture Systems (PDF Only) (PDF - 860KB) OIVD/DIHD 82 08/12/91
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers (Text Only) OIVD/DIHD 417 07/15/91
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases (PDF Only) (PDF - 376KB) OIVD/DMD 629 05/31/90

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