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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications
|
OIVD/DRD OCER/DMQRP OSEL/DIAM
|
1771
|
05/10/12
|
Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 523KB)
|
ODE OIVD
|
1772
|
03/29/12
|
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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens
|
OIVD
|
1788
|
03/19/12
|
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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
|
ODE OIVD
|
1782
|
11/10/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection
|
OIVD/DMD
|
1714
|
11/07/11
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
OIVD/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
|
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices
|
OIVD/DMD
|
1729
|
06/15/11
|
Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions
|
CDRH/OIVD CBER
|
1723
|
06/01/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection
|
OIVD/DMD
|
1677
|
05/18/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing
|
OIVD/DMD
|
1733
|
05/11/11
|
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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)
|
OIVD/DMD
|
1722
|
01/05/11
|
Draft 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
|
OIVD/DMD
|
1721
|
01/05/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile
|
OIVD/DMD
|
1715
|
11/29/10
|
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
|
OIVD/DMD
|
1712
|
09/23/10
|
Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays
|
OIVD/DCTD
|
1654
|
08/06/10
|
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
|
Assay Migration Studies for In Vitro Diagnostic Devices
|
CBER
CDRH/OIVD
|
1660
|
01/05/09
|
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
|
Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization
|
OIVD
|
1143
|
05/07/08
|
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 for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices
|
OIVD/DIHD
|
772
|
08/08/07
|
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays
|
CBER
CDRH/OIVD
|
1610
|
07/26/07
|
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
|
(Withdrawn) Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
|
OIVD/DCTD
|
1603
|
10/24/06
|
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
|
1825
|
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
|
Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff
|
OIVD/DCTD
|
152
|
12/02/03
|
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
|
Premarket Approval Application Filing Review
|
CBER
CDRH/ODE
CDRH/OIVD
|
297
|
05/01/03
|
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
|
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
|
(Withdrawn) Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA
|
OIVD/DIHD
|
800
|
08/22/01
|
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers; Final Guidance for Industry and FDA Reviewers; 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
|
(Withdrawn) Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff
|
OIVD
|
1352
|
06/24/99
|
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
|
Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology
|
OIVD/DCTD
|
604
|
02/28/97
|
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
|
Guideline for the Manufacture of In Vitro Diagnostic Products (PDF only) (PDF - 2.3MB)
|
OIVD
|
918
|
01/10/94
|
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF Only) (PDF - 1.4MB)
|
OIVD/DMD
|
862
|
07/06/93
|
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
|
Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices (PDF Only) (PDF - 934KB)
|
OIVD/DIHD
|
785
|
09/01/92
|
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents (PDF Only) (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
|
Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF Only) (PDF - 532KB)
|
OIVD/DIHD
|
475
|
09/26/91
|
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
|
Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions (Text Only)
|
OIVD
|
272
|
10/05/88
|