Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 466KB)
|
OIR/DRH OSEL/DP
|
340
|
11/18/16
|
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB)
|
OIR/DCTD
|
1755
|
10/11/16
|
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 806KB)
|
OIR/DCTD
|
1756
|
10/11/16
|
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 388KB)
|
OIR/DRH
|
644
|
09/01/16
|
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 - 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 (PDF - 116KB)
|
OIR
|
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
|
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
|