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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.


Ophthalmic

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Available
Guidance/Standard
886.1120 Ophthalmic camera. II  
  HKI -  Camera, Ophthalmic, Ac-Powered   Pilot
  MMF -  Photorefractor   Pilot
    886.1220 Corneal electrode. II  
      HLZ -  Electrode, Corneal   Pilot
      886.1250 Euthyscope. II  
        HMK -  Euthyscope, Ac-Powered   Pilot
        886.1300 Afterimage flasher. II  
          NJG -  Flasher, Afterimage, Ophthalmic   Pilot
          886.1360 Visual field laser instrument. II  
            HPJ -  Instrument, Visual Field, Laser   Pilot
            886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens. II  
              HJK -  Lens, Contact, Polymethylmethacrylate, Diagnostic   Pilot
              886.1510 Eye movement monitor. II  
                HLL -  Monitor, Eye Movement   Pilot
                  HMC -  Monitor, Eye Movement, Diagnostic   Pilot
                  886.1570 Ophthalmoscope. II  
                    HLI -  Ophthalmoscope, Ac-Powered    
                    HLJ -  Ophthalmoscope, Battery-Powered    
                    MYC -  Ophthalmoscope, Laser, Scanning    
                  886.1630 AC-powered photostimulator. II  
                    HLX -  Photostimulator, Ac-Powered   Pilot
                    886.1640 Ophthalmic preamplifier. II  
                      HLT -  Preamplifier, Ac-Powered, Ophthalmic   Pilot
                        HLW -  Preamplifier, Battery-Powered, Ophthalmic   Pilot
                        886.1670 Ophthalmic isotope uptake probe. II  
                          HPW -  Probe And Counter, Isotope, For Phosphorus 32   Pilot
                          886.1780 Retinoscope. II  
                            HKL -  Retinoscope, Ac-Powered    
                          886.1850 AC-powered slitlamp biomicroscope. II  
                            HJO -  Biomicroscope, Slit-Lamp, Ac-Powered    
                            MXK -  Device, Analysis, Anterior Segment   Pilot
                            NQE -  Microscope, Specular   Pilot
                          886.1930 Tonometer and accessories. II  
                            HKY -  Tonometer, Manual   Pilot
                            HLA -  Calibrator, Tonometer   Pilot
                            HPK -  Tonograph   Pilot
                              NJJ -  Tonometer, Analyzer, Ocular Blood Flow   Pilot
                              886.1945 Transilluminator. II  
                                HJM -  Transilluminator, Ac-Powered   Pilot
                                886.3400 Keratoprosthesis. II  
                                  MLP -  Keratoprosthesis, Temporary Implant, Surgical Use    
                                  886.4070 Powered corneal burr. I  
                                    HLD -  Engine, Trephine, Accessories, Gas-Powered    
                                      HOG -  Burr, Corneal, Battery-Powered    
                                        HQS -  Burr, Corneal, Ac-Powered    
                                          HRF -  Engine, Trephine, Accessories, Battery-Powered    
                                            HRG -  Engine, Trephine, Accessories, Ac-Powered    
                                            886.4100 Radiofrequency electrosurgical cautery apparatus. II  
                                              HQQ -  Apparatus, Cautery, Radiofrequency, Battery-Powered   Pilot
                                                HQR -  Apparatus, Cautery, Radiofrequency, Ac-Powered   Pilot
                                                  NCR -  Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered   Pilot
                                                  886.4115 Thermal cautery unit. II  
                                                    HQO -  Unit, Cautery, Thermal, Ac-Powered   Pilot
                                                      HQP -  Unit, Cautery, Thermal, Battery-Powered   Pilot
                                                      886.4150 Vitreous aspiration and cutting instrument. II  
                                                        HKP -  Instrument, Vitreous Aspiration And Cutting, Battery-Powered    
                                                          HQE -  Instrument, Vitreous Aspiration And Cutting, Ac-Powered    
                                                          MLZ -  Vitrectomy, Instrument Cutter    
                                                            MMC -  Dilator, Expansive Iris (Accessory)    
                                                              MSR -  Tubing, Replacement, Phacofragmentation Unit   Pilot
                                                              886.4170 Cryophthalmic unit. II  
                                                                HPS -  Unit, Cryophthalmic   Pilot
                                                                  HQA -  Unit, Cryotherapy, Ophthalmic   Pilot
                                                                    HRN -  Unit, Cryophthalmic, Ac-Powered   Pilot
                                                                    886.4250 Ophthalmic electrolysis unit. II  
                                                                      HRO -  Unit, Electrolysis, Ac-Powered, Ophthalmic   Pilot
                                                                      886.4300 Intraocular lens guide. I  
                                                                        KYB -  Lens, Guide, Intraocular    
                                                                        MSS -  Folders And Injectors, Intraocular Lens (Iol)    
                                                                        NCE -  Injector, Capsular Tension Ring    
                                                                      886.4335 Operating headlamp. II  
                                                                        FCT -  Headlight, Fiberoptic Focusing   Pilot
                                                                          FSR -  Light, Headband, Surgical   Pilot
                                                                            HPQ -  Headlamp, Operating, Ac-Powered   Pilot
                                                                            886.4370 Keratome. I  
                                                                              HMY -  Keratome, Battery-Powered    
                                                                                HNO -  Keratome, Ac-Powered    
                                                                                  MYD -  Keratome, Water Jet    
                                                                                  886.4390 Ophthalmic laser. II  
                                                                                    HQF -  Laser, Ophthalmic    
                                                                                    LQJ -  Lens, Surgical, Laser, Accesssory, Ophthalmic Laser    
                                                                                    886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. II  
                                                                                      LXS -  Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla    
                                                                                    886.4400 Electronic metal locator. II  
                                                                                      HPM -  Locator, Metal, Electronic   Pilot
                                                                                      886.4440 AC-powered magnet. II  
                                                                                        HPO -  Magnet, Ac-Powered   Pilot
                                                                                        886.4610 Ocular pressure applicator. II  
                                                                                          LCC -  Applicator, Ocular Pressure   Pilot
                                                                                          886.4670 Phacofragmentation system. II  
                                                                                            HQC -  Unit, Phacofragmentation    
                                                                                              MUS -  Fluidic, Phacoemulsification/Phacofragmentation   Pilot
                                                                                                MXO -  Laser, System, Phacolysis   Pilot
                                                                                              886.4690 Ophthalmic photocoagulator. II  
                                                                                                HQB -  Photocoagulator And Accessories   Pilot
                                                                                              886.4790 Ophthalmic sponge. II  
                                                                                                HOZ -  Sponge, Ophthalmic   Pilot
                                                                                                886.5100 Ophthalmic beta radiation source. II  
                                                                                                  HRL -  Unit, Beta, Radiation, Ophthalmic   Pilot
                                                                                                  886.5916 Rigid gas permeable contact lens. II  
                                                                                                    HQD -  Lens, Contact (Other Material) - Daily    
                                                                                                  886.5918 Rigid gas permeable contact lens care products. II  
                                                                                                    MRC -  Products, Contact Lens Care, Rigid Gas Permeable    
                                                                                                  886.5925 Soft (hydrophilic) contact lens. II  
                                                                                                    LPL -  Lenses, Soft Contact, Daily Wear    
                                                                                                    MVN -  Lens, Contact, (Disposable)    
                                                                                                    MZD -  System, In-Office Tinting, Contact Lenses    
                                                                                                  886.5928 Soft (hydrophilic) contact lens care products. II  
                                                                                                    HRC -  Sterilizer, Soft-Lens, Thermal, Battery-Powered   Pilot
                                                                                                    HRD -  Sterilizer, Soft-Lens, Thermal, Ac-Powered   Pilot
                                                                                                    LPN -  Accessories, Soft Lens Products    
                                                                                                    LRX -  Case, Contact Lens    
                                                                                                    LYL -  Accessories, Solution, Ultrasonic Cleaners For Lenses    

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