News Feature | July 2, 2015

FDA Exempts 120 Medical Devices From 510(k) Requirements

By Jof Enriquez,
Follow me on Twitter @jofenriq

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The U.S. Food and Drug Administration (FDA) has released a list of 120 medical devices it intends to exempt from premarket notification requirements. The FDA has deemed these devices sufficiently well understood that further regulatory review is unnecessary to ensure their safety and effectiveness before they hit market.

In the FDA's guidance document, "Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements," the agency says it will not enforce compliance with 510(k) requirements, and does not expect manufacturers to submit 510(k)s, for  these devices, though publication of a final rule or order exempting these devices from 510(k) still is pending.

The FDA had indicated, during the re-authorization process of the Medical Device User Fee Act (MDUFA) in 2012, that identifying low-risk medical devices to exempt from premarket notification requirements was an important process improvement the agency was committed to completing by the end of its 2013 fiscal year.

The Regulatory Affairs Professionals Society (RAPS) saaid in its publication Regulatory Focus that this FDA action will save medical device companies valuable time and money in bringing new devices to market. Per RAPS:

"Having a device regulated as a lower-risk product is advantageous for companies, as it allows them to avoid costly user fees, lengthy regulatory review times and many of the costs associated with developing a product. For example, consider the cost to submit a Class III device using a PMA in 2015: $250,895. In comparison, a Class I device exempt from submitting a 510(k) would cost the company nothing to submit. Another benefit: A Class I device requires no fee to market each year, whereas a Class III device must pay $8,781 to FDA each year to remain on the market. Even a 510(k) is somewhat expensive -- $5,018 per application, though most of its true costs come from obtaining the data necessary to show its equivalence to existing devices or adherence to established standards."

Among the products slated for exemption are dentures, hearing aids, and surgical lights/lamps. The following is the complete list:

Anesthesiology Devices

  • BSI - Powered Algesimeter
  • MRQ - Analyzer, Nitrogen Dioxide
  • KLK - Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
  • LPP - Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
  • JAX - Pneumotachometer
  • CCO - Bed, Rocking, Breathing AssistBTI - Compressor, Air, Portable

Cardiovascular Devices

  • DRC - Trocar
  • OCR - Lung Sound Monitor
  • DRZ - Oscillometer
  • MNW - Analyzer, Body Composition with the following labeling: Not to diagnose or treat any medical condition.
  • EAT - Tester, Pulp
  • EHR - Pad, Denture, Over The Counter
  • EHS - Cushion, Denture, Over The Counter
  • EBP - Reliner, Denture, Over The Counter
  • ELM - Denture, Plastic, Teeth
  • EKO - Denture Preformed (Partially Prefabricated Denture)
  • ELS - Splint, Endodontic Stabilizing
  • EGI - Parallelometer
  • EIB - Syringe, Irrigating (Dental)
  • KKO - Ring, Teething, Fluid-Filled

Ear, Nose & Throat Devices

  • EWD – Protector, Hearing (Insert)
  • EWE – Protector, Hearing (Circumaural)
  • LEZ – Aids, Speech Training for the Hearing Impaired (AC-Powered and PatientContact)
  • LFA – Aids, Speech Training for the Hearing Impaired (Battery-Operated or NonPatient)KLX – ElectroglottographETW - Calibrator, Hearing Aid / Earphone And
  • Analysis System
  • EPF - Hearing Aid, Group And Auditory Trainer
  • LZI – Device, Assistive Listening
  • KHL - Hearing Aid, Master
  • ETC - Mold, Middle-ear

Gastroenterology - Urology Devices

  • LRL – Cushion, HemorrhoidFCW - Light Source, Fiberoptic, Routine
  • GCT - Light Source, Endoscope, Xenon Arc
  • NTN - Led Light Source
  • FCS - Light, Catheter, Fiberoptic, Glass, Ureteral
  • EZP - Rod, Colostomy
  • FHN - Ligator, Hemorrhoidal
  • MND - Ligator, Esophageal
  • LQC - Lithotriptor, Biliary Mechanical
  • EZO - Urethrotome 
  • MNG - External Urethral Occluder, Urinary Incontinence-Control, Female
  • EZM - Dilator, Esophageal (Metal Olive) Gastro-urology
  • FAT - Bougie, Esophageal, And Gastrointestinal, Gastro-urology
  • KNQ - Dilator, Esophageal 
  • NIH - Disinfectant, Subsystem, Water Purification
  • EXD - Irrigator, Ostomy
  • LKB - Pad, Alcohol, Device Disinfectant
  • OVR - Kit, First Aid, Talking
  • ERY - Drape, Surgical, Ent
  • EYX - Drape, Pure Latex Sheet, With Self-retaining Finger Cot
  • EYY - Drape, Urological, Disposable
  • FNW - Pad, Kelly
  • HMT - Drape, Patient, Ophthalmic
  • HMW - Drape, Microscope, Ophthalmic
  • KGW - Ring (Wound Protector), Drape Retention, Internal
  • KKX - Drape, Surgical
  • FSQ - Light, Surgical, Instrument
  • FSS - Light, Surgical, Floor Standing
  • FSW - Light, Surgical, Endoscopic
  • FSX - Light, Surgical, Connector
  • FSY - Light Surgical, Ceiling mounted
  • FSZ - Light, Surgical, Carrier
  • FTD - Lamp, Surgical
  • FTG - Illuminator, Remote
  • FQP - Lamp, Operating-room
  • GBC - Lamp, Surgical, IncandescentFZG - Apparatus, Air Handling, Bench
  • FZH - Apparatus, Air Handling, Room
  • FZI - Apparatus, Air Handling, Enclosure

General Hospital and Personal Use Devices

  • DWL - Stocking, Medical Support (To Prevent Pooling Of Blood in Legs)
  • LZB - Finger CotKMJ – Lubricant, Patient
  • KMG - Purifier, Water, Ultraviolet, Medical
  • BRT - Restraint, Patient, Conductive
  • FMQ - Restraint, Protective
  • OYS - Patient Bed With Canopy/Restraints

Neurological Devices

  • LLN - Device, Vibration Threshold Measurement
  • LQW - Test, Temperature Discrimination
  • GWW - Ataxiagraph
  • HCD - Cannula, Ventricular
  • GYK - Instrument, Shunt System Implantation

Obstetrical and Gynecological Devices

  • LHD - Device, Fertility Diagnostic, Proceptive
  • LHM – System, Thermographic, Liquid Crystal
  • KYA – System, Thermographic Liquid Crystal, Nonpowered (Adjunctive Use)
  • HFL - Drain, Cervical
  • HDA - Forceps, Obstetrical
  • HIB - Speculum, Vaginal, Nonmetal
  • HFW - Clamp, Umbilical
  • OOA – Hemorrhoid, Prevention, Pressure, Wedge
  • HGZ - Heater, Perineal, Direct Contact
  • HHA - Heater, Perineal, Radiant, Non-contact
  • KND - Heater, Perineal
  • HHE - Cup, Menstrual
  • NUQ - Pad, Menstrual, Reusable
  • NUR – Pad, Interlabial
  • KXQ - Vibrator For Therapeutic Use, Genital

Ophthalmic Devices

  • PJZ - Camera, Ophthalmic, AC-Powered, General-Use
  • MMF - Photorefractor
  • HMK - Euthyscope, AC-powered
  • HJM - Transilluminator, AC-powered
  • HLD - Engine, Trephine, Accessories, Gas-powered
  • HOG - Burr, Corneal, Battery-powered
  • HRF - Engine, Trephine, Accessories, Battery-powered
  • HRG - Engine, Trephine, Accessories, AC-powered
  • HQS - Burr, Corneal, AC-powered
  • HRO - Unit, Electrolysis, AC-powered, Ophthalmic
  • FCT - Headlight, Fiberoptic Focusing
  • FSR - Light, Headband, Surgical
  • HPQ - Headlamp, Operating, AC-powered
  • HPM - Locator, Metal, Electronic
  • HPO - Magnet, AC-Powered 
  • HOZ - Sponge, Ophthalmic

Physical Medicine Devices

  • LZW – Monitor, Spine CurvatureIKO - Hammer, Reflex, Powered
  • ILJ - Bath, Hydro-massage
  • ILM - Bath, Sitz, Powered
  • IMC - Bath, Paraffin
  • ISD - Exerciser, Measuring
  • IRN - Device, Warning, Overload, External Limb, Powered