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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 & Plastic Surgery

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
878.4040 SURGICAL APPAREL II  
  HTML Guidance file for SURGICAL APPAREL (21CFR878.4040)
  MSH -  Respirator,Surgical      
  FXX -  Mask, Surgical   Pilot  
  FXY -  Hood, Surgical   Pilot  
  FYA -  Gown, Surgical   Pilot  
  FYB -  Gown, Patient   Pilot  
  FYC -  Gown, Isolation, Surgical   Pilot  
878.4200 INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES I  
 General Guidance
  OAJ -  Catheter, Drainage, Intraoral/Extraoral      
878.4350 CRYOSURGICAL UNIT AND ACCESSORIES II  
  FAZ -  System, Cryosurgical, Liquid Nitrogen, For Urology   Pilot  
  GEH -  Unit, Cryosurgical, Accessories   Pilot  
878.4370 SURGICAL DRAPE AND DRAPE ACCESSORIES II  
  MMP -  Cover, Barrier, Protective   Pilot  
  ERY -  Drape, Surgical, Ent   Pilot  
  EYX -  Drape, Pure Latex Sheet, With Self-Retaining Finger Cot   Pilot  
  EYY -  Drape, Urological, Disposable   Pilot  
  FNW -  Pad, Kelly   Pilot  
  HMT -  Drape, Patient, Ophthalmic   Pilot  
  HMW -  Drape, Microscope, Ophthalmic   Pilot  
  KGW -  Ring (Wound Protector), Drape Retention, Internal   Pilot  
  KKX -  Drape, Surgical   Pilot  
  LRO -  General Surgery Tray (Kit)   Pilot  
878.4400 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES II  
Guidance Withdrawn
  OCL -  Surgical Device, For Ablation Of Cardiac Tissue   Pilot  
  BWA -  Unit, Electrosurgical Andcoagulation, With Accessories      
  DWG -  Electrosurgical Device      
  GEI -  Electrosurgical, Cutting & Coagulation & Accessories      
  HAM -  Apparatus, Electrosurgical      
  JOS -  Electrode, Electrosurgical      
  JOT -  Electrode, Gel, Electrosurgical      
  MUL -  Generator,Electrosurgical,Coagulation,Cancer      
  ONQ -  Electrosurgical Coagulation For Aesthetic      
878.4410 LOW ENERGY ULTRASOUND WOUND CLEANER II  
  NRB -  Wound Cleaner, Ultrasound      
878.4460 SURGEON'S GLOVES I  
 General Guidance
  KGO -  Surgeon'S Gloves      
878.4580 SURGICAL LAMP II  
  FQP -  Lamp, Operating-Room      
  FSQ -  Light, Surgical, Instrument      
  FSS -  Light, Surgical, Floor Standing      
  FST -  Light, Surgical, Fiberoptic      
  FSW -  Light, Surgical, Endoscopic      
  FSX -  Light, Surgical, Connector      
  FSY -  Light, Surgical, Ceiling Mounted      
  FSZ -  Light, Surgical, Carrier      
  FTA -  Light, Surgical, Accessories      
  FTD -  Lamp, Surgical      
  FTF -  Illuminator, Non-Remote      
  FTG -  Illuminator, Remote      
  GBC -  Lamp, Surgical, Incandescent      
  HBI -  Illuminator, Fiberoptic, Surgical Field      
  HJE -  Lamp, Fluorescein, Ac-Powered      
878.4630 DERMATOLOGIC ULTRAVIOLET LAMP II  
  FTC -  Light, Ultraviolet, Dermatological   Pilot  
878.4780 POWERED SUCTION PUMP II  
  BTA -  Pump, Portable, Aspiration (Manual Or Powered)      
  JCX -  Apparatus, Suction, Ward Use, Portable, Ac-Powered      
878.4810 LASER SURGICAL INSTRUMENT FOR USE IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY II  
  ONO -  Neurosurgical Laser With Mr Thermography      
  GEX -  Powered Laser Surgical Instrument      
878.5040 SUCTION LIPOPLASTY SYSTEM II  
  MUU -  System, Suction, Lipoplasty   Pilot  
878.5070 AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM II  
  FLJ -  Unit, Airflow, Laminar   Pilot  
  FRT -  Unit, Isolation, Surgical   Pilot  
  FYD -  Apparatus, Exhaust, Surgical   Pilot  
  FZG -  Apparatus, Air Handling, Bench   Pilot  
  FZH -  Apparatus, Air Handling, Room   Pilot  
  FZI -  Apparatus, Air Handling, Enclosure   Pilot  

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