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  5. Class II Special Controls Documents
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Class II Special Controls Documents

This page lists special controls guidance and guideline documents developed by CDRH and CBER.

Devices classified into class II are devices for which special controls, combined with general controls, are necessary to provide reasonable assurance of safety and effectiveness. These documents set forth the special controls for the applicable Class II devices. While these documents describe a means by which a device may comply with the requirement of special controls, the risks to health identified in these documents must be addressed. Thus, a manufacturer who intends to market a device within a generic type of device covered by these documents must:

  • conform to the general controls in Section 513(a)(1)(A) of the Federal Food Drug & Cosmetic Act (the Act);
  • address the specific risks (Section 513(a)(1)(B) of the FD&C Act) to health identified, either by meeting the recommendations in the guidance/guidelines or by some other means that provides equivalent assurances of safety and effectiveness; and
  • for devices not exempt from premarket notification, obtain a substantial equivalence determination (Sections 510(k) and 513(i) of the FD&C Act, and 21 CFR 807.100) from FDA prior to marketing the device.

For additional information on specific device classification, please refer to the Code of Federal Regulations, of Title 21 in Parts 862 to 892 and FDA's product classification database.

Title Issue date FDA Organization
Guidance on 510(k) Submissions for Implanted Infusion Ports 10/1/1990 CDRH
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses 6/27/1994 CDRH
Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters 3/15/1995 CDRH
Guidance for Hemodialyzer Reuse Labeling 10/6/1995 CDRH
Premarket Notification 510(k) Guidance for Contact Lens Care Products 5/1/1997 CDRH
Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems - Guidance for Industry and CDRH Reviewers 8/6/1998 CDRH
Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers - Guidance for Industry and CDRH Reviewers 8/6/1998 CDRH
Class II Special Controls Guidance Document for Clitoral Engorgement Devices - Guidance for Industry and FDA Reviewers 7/2/2000 CDRH
Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices - Guidance for Industry and FDA Reviewers 7/2/2000 CDRH
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi - Guidance for Industry and for FDA Reviewers 8/8/2000 CDRH
Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications - Guidance for Industry and FDA Reviewers 8/22/2000 CDRH
Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis - Guidance for Industry and FDA Staff 10/30/2000 CDRH
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions - Guidance for Industry 10/31/2000 CDRH
Guidance Document for Vascular Prostheses 510(k) Submissions - Guidance for Industry and FDA Staff 10/31/2000 CDRH
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions - Final Guidance for Industry and FDA Staff 11/12/2000 CDRH
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions - Final Guidance for Industry and FDA 11/28/2000 CDRH
Guidance for Extracorporeal Blood Circuit Defoamer - 510(k) Submissions - Final Guidance for Industry and FDA 11/28/2000 CDRH
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications - Final Guidance for Industry and FDA Reviewers 11/29/2000 CDRH
Guidance for Annuloplasty Rings 510(k) Submissions - Final Guidance for Industry and FDA Staff 1/30/2001 CDRH
Class II Special Controls Guidance for Home Uterine Activity Monitors - Final Guidance for Industry and FDA Reviewers 3/8/2001 CDRH
Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA 3/11/2001 CDRH
Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications - Final Guidance for Industry and FDA Reviewers 5/15/2001 CDRH
Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers - Final Guidance for Industry and FDA 10/4/2001 CDRH
Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA 11/27/2001 CDRH
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 12/3/2001 CDRH
Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff 2/6/2002 CDRH
Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve - Guidance for Industry and FDA 4/28/2002 CDRH
Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA 4/29/2002 CDRH
Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement - Guidance for Industry and FDA 7/16/2002 CDRH
Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA 7/16/2002 CDRH
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis - Guidance for Industry and FDA 8/29/2002 CDRH
Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays - Guidance for Industry and FDA 9/15/2002 CDRH
Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA 11/6/2002 CDRH
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Guidance for Industry and FDA 11/11/2002 CDRH
Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors - Guidance for Industry and FDA 12/12/2002 CDRH
Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA 1/15/2003 CDRH
Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA 4/21/2003 CDRH
Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device - Guidance for Industry and FDA Staff 6/1/2003 CDRH
Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff 6/2/2003 CDRH
Class II Special Controls Guidance Document: Breath Nitric Oxide Test System - Guidance for Industry and FDA Staff 7/6/2003 CDRH
Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff 7/27/2003 CDRH
Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm - Guidance for Industry and FDA Staff 10/27/2003 CDRH
Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Guidance for Industry and FDA Staff 10/29/2003 CDRH
Class II Special Controls Guidance Document: Endotoxin Assay - Guidance for Industry and FDA Staff 10/30/2003 CDRH
Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff 12/1/2003 CDRH
Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff 3/15/2004 CDRH
Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Guidance for Industry and FDA Staff 5/10/2004 CDRH
Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff 5/11/2004 CDRH
Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff 8/22/2004 CDRH
Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff 8/22/2004 CDRH
Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan - Guidance for Industry and FDA Staff 9/22/2004 CDRH
Class II Special Controls Guidance Document: Sirolimus Test Systems - Guidance for Industry and FDA Staff 9/29/2004 CDRH
Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry - Guidance for Industry and FDA Staff 11/23/2004 CDRH
Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff 12/9/2004 CDRH
Class II Special Controls Guidance Document: External Penile Rigidity Devices - Guidance for Industry and FDA Staff 12/27/2004 CDRH
Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems - Guidance for Industry and FDA Staff 12/27/2004 CDRH
Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices - Guidance for Industry and FDA Staff 12/28/2004 CDRH
Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System - Guidance for Industry and FDA Staff 3/9/2005 CDRH
Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems - Guidance for Industry and FDA Staff 3/22/2005 CDRH
Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices - Guidance for Industry and FDA Staff 4/27/2005 CDRH
Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing) - Guidance for Industry and FDA Staff 8/24/2005 CDRH
Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque - Guidance for Industry and FDA Staff 9/19/2005 CDRH
Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems - Guidance for Industry and FDA Staff 10/25/2005 CDRH
Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner - Guidance for Industry and FDA Staff 11/6/2005 CDRH
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays 2/8/2006 CDRH
Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System - Guidance for Industry and FDA Staff 2/14/2006 CDRH
Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses - Guidance for Industry and FDA Staff 3/21/2006 CDRH
Class II Special Controls Guidance Document: Olfactory Test Device - Guidance for Industry and FDA Staff 6/6/2006 CDRH
Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems - Guidance for Industry and FDA Staff 7/26/2006 CDRH
Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays: Guidance for Industry and FDA Staff 1/10/2007 CDRH
Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems - Guidance for Industry and FDA Staff 4/23/2007 CDRH
Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis - Guidance for Industry and FDA Staff 5/8/2007 CDRH
Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies - Guidance for Industry and FDA Staff 7/2/2007 CDRH
Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology - Guidance for Industry and FDA Staff 8/2/2007 CDRH
Class II Special Controls Guidance Document: Remote Medication Management System - Guidance for Industry and FDA Staff 10/18/2007 CDRH
Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays 5/19/2008 CDRH
Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin - Guidance for Industry and FDA Staff 5/29/2008 CDRH
Class II Special Controls Guidance Document: Bone Sonometers - Guidance for Industry and FDA Staff 7/16/2008 CDRH
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 12/23/2008 CDRH
Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA 1/1/2009 CDRH
Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide: Guidance for Industry 1/5/2009 CDRH
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff 7/27/2009 CDRH
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems 8/27/2009 CDRH
Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - Guidance for Industry and FDA Staff 10/8/2009 CDRH
Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays - Guidance for Industry and FDA Staff 10/8/2009 CDRH
Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays - Guidance for Industry and FDA Staff 10/8/2009 CDRH
Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive - Guidance for Industry and FDA Staff 10/15/2009 CDRH
Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems - Guidance for Industry and FDA Staff 10/20/2009 CDRH
Contact Lens Care Products Labeling - Guidance for Industry and Food and Drug Administration Staff 8/14/2010 CDRH
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters 9/7/2010 CDRH
Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) - Guidance for Industry and FDA Staff 11/9/2010 CDRH
Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin - Guidance for Industry and FDA Staff 11/9/2010 CDRH
Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use - Guidance for Industry and FDA Staff 2/6/2011 CDRH
Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System - Guidance for Industry and FDA Staff 3/22/2011 CDRH
Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use - Guidance for Industry and FDA Staff 4/13/2011 CDRH
Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities - Guidance for Industry and FDA Staff 4/24/2011 CDRH
Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use - Guidance for Industry and FDA Staff 7/19/2011 CDRH
Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff 7/20/2011 CDRH
Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and FDA Staff 7/25/2011 CDRH
Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays: Guidance for Industry and FDA Staff 8/9/2011 CDRH
Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection - Draft Guidance for Industry and Food and Drug Administration Staff 11/6/2011 CDRH
Class II Special Controls Guidance Document: Norovirus Serological Reagents - Guidance for Industry and Food and Drug Administration Staff 3/8/2012 CDRH
Class II Special Controls Guidance Document: Full Field Digital Mammography System - Guidance for Industry and FDA Staff 3/26/2012 CDRH
Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate - Guideline for Industry and Food and Drug Administration Staff 12/29/2013 CDRH
Class II Special Controls Guideline: John Cunningham Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff 1/23/2014 CDRH
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 5/29/2014 CDRH
Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff 5/29/2014 CDRH
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 Spec: Guideline for Industry and Food and Drug Administration Staff 5/30/2014 CDRH
Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents: Guideline for Industry and Food and Drug Administration Staff 9/10/2014 CDRH
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 9/18/2014 CDRH
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 5/27/2015 CDRH
Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis: Guideline for Industry and Food and Drug Administration Staff 8/4/2015 CDRH
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 8/27/2015 CDRH
Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection: Guideline for Industry and Food and Drug Administration Staff 4/1/2019 CDRH
Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems 10/04/2005 CDRH
Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems - Guidance for Industry and FDA Staff 03/09/2005 CDRH
Class II Special Controls Guidance Document: Intervertebral Body Fusion Device: Guidance for Industry and FDA Staff 3/1/2011 CDRH
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 11/2/2015 CDRH
Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis: Guidance 5/30/1997 CDRH
Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle: Guidance for Industry and FDA Staff 3/1/2011 CBER
Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container: Guidance for Industry 3/1/2011 CBER
Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay: Guidance for Industry 3/1/2011 CBER
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA 9/19/1996 CDRH
Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables 11/15/1999 CDRH
Guidance for Submission of Immunohistochemistry Applications to the FDA - Final Guidance for Industry 6/3/1998 CDRH
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test - Final Guidance for Industry and FDA Reviewers/Staff 4/27/1999 CDRH