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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.

Ear Nose & Throat

Section No. Regulation Name
Product Code-Device Name
Class Pilot
874.1090 Auditory impedance tester. II  
  ETY -  Tester, Auditory Impedance   Pilot  
  NAS -  Tympanometer   Pilot  
874.1120 Electronic noise generator for audiometric testing. II  
  ETS -  Generator, Electronic Noise (For Audiometric Testing)   Pilot  
874.1325 Electroglottograph. II  
  KLX -  Electroglottograph   Pilot  
874.1820 Surgical nerve stimulator/locator. II  
  ETN -  Stimulator, Nerve   Pilot  
874.3300 Hearing Aid. II  
  LXB -  Hearing Aid, Bone Conduction   Pilot  
874.3310 Hearing aid calibrator and analysis system. II  
  ETW -  Calibrator, Hearing Aid / Earphone And Analysis Systems   Pilot  
874.3320 Group hearing aid or group auditory trainer. II  
  EPF -  Hearing Aid, Group And Auditory Trainer   Pilot  
874.3330 Master hearing aid. II  
  KHL -  Hearing Aid, Master   Pilot  
874.3400 Tinnitus masker. II  
  KLW -  Masker, Tinnitus      
874.3730 Laryngeal prosthesis (Taub design). II  
  EWL -  Prosthesis, Laryngeal (Taub)   Pilot  
  MCK -  Device, Voice Amplification   Pilot  
874.4250 Ear, nose, and throat electric or pneumatic surgical drill. II  
  ERL -  Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   Pilot  
874.4490 Argon laser for otology, rhinology, and laryngology. II  
  LMS -  Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology      
  LXR -  Laser, Microsurgical Argon, For Use In Otology      
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. II  
  LLO -  Laser, Neodymium:Yag, Pulmonary Surgery   Pilot  
  EWG -  Laser, Ent Microsurgical Carbon-Dioxide      
874.4680 Bronchoscope (flexible or rigid) and accessories. II  
  BST -  Currette, Biopsy, Bronchoscope (Non-Rigid)   Pilot  
  BTG -  Brush, Biopsy, Bronchoscope (Non-Rigid)   Pilot  
  BWH -  Forceps, Biopsy, Bronchoscope (Non-Rigid)   Pilot  
  ENZ -  Telescope, Laryngeal-Bronchial   Pilot  
  EOQ -  Bronchoscope (Flexible Or Rigid)   Pilot  
  JEI -  Claw, Foreign Body, Bronchoscope (Non-Rigid)   Pilot  
  JEJ -  Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)   Pilot  
  JEK -  Forceps, Biopsy, Bronchoscope (Rigid)   Pilot  
  JEL -  Curette, Biopsy, Bronchoscope (Rigid)   Pilot  
  KTI -  Bronchoscope Accessory      
  KTR -  Tube, Aspirating, Bronchoscope, Rigid   Pilot  
874.4710 Esophagoscope (flexible or rigid) and accessories. II  
  EOX -  Esophagoscope (Flexible Or Rigid)   Pilot  
874.4720 Mediastinoscope and accessories. II  
  EWY -  Mediastinoscope, Surgical   Pilot  
874.4760 Nasopharyngoscope (flexible or rigid) and accessories. II  
  EOB -  Nasopharyngoscope (Flexible Or Rigid)   Pilot  
  EQN -  Laryngoscope, Nasopharyngoscope   Pilot