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FDA Proposes to Exempt Certain Devices from 510(k) Requirements

On August 1, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” FDA has identified certain class I and II devices for which risks, safety, and effectiveness have been established well enough for the agency to deem premarket notification as being no longer necessary. The agency has proposed to exempt these devices from premarket notification requirements to comply with the agency’s commitment letter that was drafted in the 2012 Medical Device User Fee Amendments of 2012 (MDUFA).

The draft guidance lists over 100 product codes of devices that FDA proposes to exempt from 510(k) requirements, which we have listed at the end of this blog. FDA has indicated that it will not enforce 510(k) requirements for the listed devices while the agency continues the process of finalizing the guidance and creating a formal final rule to exempt the devices. Devices that are exempt from 510(k) requirements must still comply with other FDA regulations, such as registration, labeling, and good manufacturing practice requirements.

While comments about the draft may be submitted at any time, FDA recommends that comments be submitted before September 30, 2014, to ensure consideration before creation of the final guidance.

Registrar Corp can help a medical device establishment determine whether or not its device requires a 510(k). For devices that still require clearance, Registrar Corp’s 510(k) Administrative Review and Submission Service can ensure that a 510(k) is properly formatted and submitted. Registrar Corp can also assist establishments with FDA registration, listing, and labeling requirements.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. For questions about FDA medical device regulation or to learn more about how Registrar Corp can assist your establishment, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

FDA plans to exempt the following products from 510(k) requirements:

  1. BSI – Powered Algesimeter
  2. MRQ – Analyzer, Nitrogen Dioxide
  3. KLK – Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
  4. LPP – Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
  5. JAX – Pneumotachometer
  6. CCO – Bed, Rocking, Breathing Assist
  7. BTI – Compressor, Air, Portable
  8. DRC – Trocar
  9. OCR – Lung Sound Monitor
  10. DRZ – Oscillometer
  11. MNW – Analyzer, Body Composition with the following labeling: Not to diagnose or  treat any medical condition. If the labeling or intended use suggests use with a specific medical condition, then a 510(k) submission would still be required
  12. EAT – Tester, Pulp
  13. EHR – Pad, Denture, Over The Counter
  14. EHS – Cushion, Denture, Over The Counter
  15. EBP – Reliner, Denture, Over The Counter
  16. ELM – Denture, Plastic, Teeth
  17. EKO – Denture Preformed (Partially Prefabricated Denture)
  18. ELS – Splint, Endodontic, Stabilizing
  19. EGI – Parallelometer
  20. KKO – Ring, Teething, Fluid-Filled
  21. ETW – Calibrator, Hearing Aid / Earphone And Analysis System
  22. EPF – Hearing Aid, Group And Auditory Trainer
  23. KHL – Hearing Aid, Master
  24. ETC – Mold, Middle-ear
  25. FCW – Light Source, Fiberoptic, Routine
  26. GCT – Light Source, Endoscope, Xenon Arc
  27. NTN – Led Light Source
  28. FCS – Light, Catheter, Fiberoptic, Glass, Ureteral
  29. EZP – Rod, Colostomy
  30. FHN – Ligator, Hemorrhoidal
  31. MND – Ligator, Esophegeal
  32. LQC – Lithotriptor, Biliary Mechanical
  33. EZO – Urethrotome
  34. MNG – External Urethral Occluder, Urinary Incontinence-Control, Female
  35. EZM – Dilator, Esophageal (Metal Olive) Gastro-urology
  36. FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-urology
  37. KNQ – Dilator, Esophageal
  38. NIH – Disinfectant, Subsystem, Water Purification
  39. EXD – Irrigator, Ostomy
  40. LKB – Pad, Alcohol, Device Disinfectant
  41. OVR- Kit, First Aid, Talking
  42. ERY – Drape, Surgical, Ent
  43. EYX – Drape, Pure Latex Sheet, With Self-retaining Finger Cot
  44. EYY – Drape, Urological, Disposable
  45. FNW – Pad, Kelly
  46. HMT – Drape, Patient, Ophthalmic
  47. HMW – Drape, Microscope, Ophthalmic
  48. KGW – Ring (Wound Protector), Drape Retention, Internal
  49. KKX – Drape, Surgical
  50. FSQ – Light, Surgical, Instrument
  51. FSS – Light, Surgical, Floor Standing
  52. FSW – Light, Surgical, Endoscopic
  53. FSX – Light, Surgical, Connector
  54. FSY – Light Surgical, Celling mounted
  55. FSZ – Light, Surgical, Carrier
  56. FTD – Lamp, Surgical
  57. FTG – Illuminator, Remote
  58. FQP – Lamp, Operating-room
  59. GBC – lamp, Surgical, Incandescent
  60. FZG – Apparatus, Air Handling, Bench
  61. FZH – Apparatus, Air Handling, Room
  62. FZI – Apparatus, Air Handling, Enclosure
  63. FLL – Thermometer, Electrical, Clinical
  64. DWL – Stocking, Medical Support (To Prevent Pooling Of Blood in Legs)
  65. LZB – Finger Cot
  66. KMG – Purifier, Water, Ultraviolet, Medical
  67. BRT – Restraint, Patient, Conductive
  68. FMQ – Restraint, Protective
  69. LLN – Device, Vibration Threshold Measurement. If device contains software to analyze clinical implication of the measurement, a 510(k) will be required.
  70. LQW – Test, Temperature Discrimination. If device contains software to analyze clinical implication of the measurement, a 510(k) will be required.
  71. GWW – Ataxiagraph. If device contains software to analyze clinical implication of the measurement a 510(k) will be required.
  72. GWO – Plate, Cranioplasty, Preformed, Alterable
  73. LHD – Device, Fertility Diagnostic, Proceptive
  74. HFL – Drain, Cervical
  75. HDA – Forceps, Obstetrical
  76. HIB – Speculum, Vaginal, Nonmetal
  77. HFW – Clamp, Umbilical
  78. OOA – Hemorrhoid, Prevention, Pressure, Wedge
  79. HGZ – Heater, Perineal, Direct Contact
  80. HHA – Heater, Perineal, Radiant, Non-contact
  81. KND – Heater, Perineal
  82. HHE – Cup, Menstrual
  83. NUQ – Pad, Menstrual, Reusable
  84. KXQ – Vibrator For Therapeutic Use, Genital
  85. HKI – Camera, Ophthalmic, AC-powered
  86. MMF – Photorefractor
  87. HMK – Euthyscope, AC-powered
  88. HJM – Transilluminator, AC-powered
  89. HLD – Engine, Trephine, Accessories, Gas-powered
  90. HOG – Burr, Corneal, Battery-powered
  91. HRF – Engine, Trephine, Accessories, Battery-powered
  92. HRG – Engine, Trephine, Accessories, AC-powered
  93. HQS – Burr, Corneal, AC-powered
  94. HRO – Unit, Electrolysis, AC-powered, Ophthalmic
  95. FCT – Headlight, Fiberoptic Focusing
  96. FSR – Light, Headband, Surgical
  97. HPQ – Headlamp, Operating, AC-powered
  98. HPM – Locator, Metal, Electronic
  99. HPO – Magnet, AC-Powered
  100. HOZ – Sponge, Ophthalmic
  101. IKO – Hammer, Reflex, Powered
  102. LQX – Device, Finger-sucking
  103. ILJ -Bath, Hydro-massage
  104. ILM – Bath, Sitz, Powered
  105. IMC – Bath, Paraffin
  106. ISD – Exerciser, Measuring
  107. IRN – Device, Warning, Overload, External Limb, Powered

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