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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


General Hospital

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
880.2420 Electronic monitor for gravity flow infusion systems. II  
  FLN -  Monitor, Electric For Gravity Flow Infusion Systems   Pilot  
880.2460 Electrically powered spinal fluid pressure monitor. II  
  CAR -  Monitor, Spinal-Fluid Pressure, Electrically Powered   Pilot  
880.2500 Spinal fluid manometer. II  
  FMJ -  Manometer, Spinal-Fluid   Pilot  
880.2800 Sterilization process indicator. II  
  FRC -  Indicator, Biological Sterilization Process   Pilot  
  JOJ -  Indicator, Physical/Chemical Sterilization Process   Pilot  
  LRT -  Indicator, Sterilization   Pilot  
  MRB -  Indicator, Biological, Liquid Chemical Sterilization Process   Pilot  
  MTC -  Indicator,Chemical,Enzymatic,Sterilization Process   Pilot  
880.2910 Clinical electronic thermometer. II  
  FLL -  Thermometer, Electronic, Clinical      
880.5025 I.V. container. II  
  KPE -  Container, I.V.   Pilot  
880.5045 Medical recirculating air cleaner. II  
  FRF -  Cleaner, Air, Medical Recirculating   Pilot  
880.5090 Liquid bandage. I  
 General Guidance
  KMF -  Bandage, Liquid      
  NEC -  Bandage, Liquid, Skin Protectant      
880.5130 Infant radiant warmer. II  
  FMT -  Warmer, Infant Radiant   Pilot  
880.5200 Intravascular catheter. II  
  HTML Guidance file for Intravascular catheter. (21CFR880.5200)
  FOS -  Catheter, Umbilical Artery      
  FOZ -  Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days      
880.5400 Neonatal incubator. II  
  FMZ -  Incubator, Neonatal      
880.5410 Neonatal transport incubator. II  
  FPL -  Incubator, Neonatal Transport      
880.5430 Nonelectrically powered fluid injector. II  
  KZE -  Injector, Fluid, Non-Electrically Powered   Pilot  
880.5440 Intravascular administration set. II  
  BRZ -  Set, Blood Transfusion      
  FMG -  Stopcock, I.V. Set      
  FPA -  Set, Administration, Intravascular      
  FPB -  Filter, Infusion Line      
  FPK -  Tubing, Fluid Delivery      
  LHI -  Set, I.V. Fluid Transfer      
  MJF -  Check Valve, Retrograde Flow (In-Line)      
880.5450 Patient care reverse isolation chamber. II  
  FRR -  Chamber, Reverse Isolation, Patient Care   Pilot  
  LGM -  Chamber, Patient Isolation   Pilot  
  LGN -  Chamber, Patient Transport Isolation   Pilot  
880.5570 Hypodermic single lumen needle. II  
  FMI -  Needle, Hypodermic, Single Lumen      
  MMK -  Container, Sharps      
880.5580 Acupuncture needle. II  
  MQX -  Needle, Acupuncture, Single Use   Pilot  
880.5680 Pediatric position holder. I  
 General Guidance
  FRP -  Holder, Infant Position      
880.5700 Neonatal phototherapy unit. II  
  LBI -  Unit, Neonatal Phototherapy   Pilot  
880.5725 Infusion pump. II  
PDF Guidance file for Infusion pump. (21CFR880.5725)  
  FRN -  Pump, Infusion      
  LZF -  Pump, Infusion, Analytical Sampling      
  LZH -  Pump, Infusion, Enteral      
  MEA -  Pump, Infusion, Pca      
  MEB -  Pump, Infusion, Elastomeric      
  MHD -  Pump, Infusion, Gallstone Dissolution      
  MRZ -  Accessories, Pump, Infusion      
  MRH -  Pump, Infusion, Ophthalmic   Pilot  
880.5780 Medical support stocking. II  
  DWL -  Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)   Pilot  
880.5860 Piston syringe. II  
  FMF -  Syringe, Piston      
880.6100 Ethylene oxide gas aerator cabinet. II  
  FLI -  Cabinet, Ethylene-Oxide Gas Aerator   Pilot  
880.6250 Patient examination glove. I  
 General Guidance
  FMC -  Patient Examination Glove      
  LYY -  Latex Patient Examination Glove      
  LYZ -  Vinyl Patient Examination Glove      
  LZA -  Polymer Patient Examination Glove      
  LZB -  Finger Cot      
  LZC -  Patient Examination Glove, Specialty      
880.6375 Patient lubricant. I  
 General Guidance
  KMJ -  Lubricant, Patient      
  MMS -  Lubricant, Vaginal, Patient      
880.6500 Medical ultraviolet air purifier. II  
  FRA -  Purifier, Air, Ultraviolet, Medical   Pilot  
  MKB -  Device, Germicidal, Ultraviolet   Pilot  
880.6710 Medical ultraviolet water purifier. II  
  KMG -  Purifier, Water, Ultraviolet, Medical   Pilot  
880.6740 Vacuum-powered body fluid suction apparatus. II  
 
  PAD -  Chest Drainage Kit      
880.6760 Protective restraint. I  
  BRT -  Restraint, Patient, Conductive      
  FMQ -  Restraint, Protective      
880.6850 Sterilization wrap. II  
  FRG -  Wrap, Sterilization   Pilot  
  KCT -  Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   Pilot  
880.6860 Ethylene oxide gas sterilizer. II  
  FLF -  Sterilizer, Ethylene-Oxide Gas   Pilot  
  MLR -  Sterilizer, Chemical   Pilot  
880.6870 Dry-heat sterilizer. II  
  KMH -  Sterilizer, Dry Heat   Pilot  
880.6880 Steam sterilizer. II  
  HTML Guidance file for Steam sterilizer. (21CFR880.6880)
  FLE -  Sterilizer, Steam      
880.6885 Liquid chemical sterilants/high level disinfectants. II  
  LFE -  Solution, Cold Sterilizing   Pilot  
  MED -  Sterilant, Medical Devices      
880.6920 Syringe needle introducer. II  
  KZH -  Introducer, Syringe Needle   Pilot  

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