FDA Exempts 120 Medical Device Types from Most Regulation

Regulatory NewsRegulatory News | 30 June 2015 |  By 

The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices.


Under existing regulations, FDA regulates devices according to three general categories:

  • Class III – High-risk devices; require the submission of a Premarket Application (PMA).
  • Class II – Moderate-risk devices; require the submission of a Premarket Notification Application (510(k)); must either show substantial equivalence to an existing device or compliance with established "special" controls.
  • Class I – Low-risk devices; exempt from premarket notification; must meet "general" controls.

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.

Regulatory Exemptions

Clearly, then, medical device companies like it when their devices are subject to lesser amounts of regulation. It means they can bring their products to market more quickly and with less of an up-front investment in resources. The issue received prominent attention in 2012 under the third reauthorization of the Medical Device User Fee Act (MDUFA), when FDA committed to proposing "additional low risk medical devices to exempt from premarket notification" by the end of Fiscal Year 2013.

"Within two years of such proposal, FDA intends to issue a final rule exempting additional low risk medical devices from premarket notification," it wrote.

Now FDA is signaling its intent to exempt many devices from premarket notification requirements.

"The FDA believes devices identified … are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness," it wrote in its new final guidance document, Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.

While FDA intends to eventually exempt these devices from premarket notification through the notice and rulemaking process, it says it will not "enforce compliance with 510(k) requirements" in the meantime, and will not require companies to submit a 510(k).

The exempt devices are as follows:

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
JAX - Pneumotachometer
CCO - Bed, Rocking, Breathing Assist
BTI - Compressor, Air, Portable
DRC - Trocar
OCR - Lung Sound Monitor
DRZ - Oscillometer
MNW - Analyzer, Body Composition with the following labeling: Not to diagnose or treat any medical condition. This intention does not apply to devices where the labeling or intended use suggests use with a specific 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
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 – Electroglottograph
ETW - 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
LRL – Cushion, Hemorrhoid
FCW - 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, Celling mounted
FSZ - Light, Surgical, Carrier
FTD - Lamp, Surgical
FTG - Illuminator, Remote
FQP - Lamp, Operating-room
GBC - Lamp, Surgical, Incandescent
FZG - Apparatus, Air Handling, Bench
FZH - Apparatus, Air Handling, Room
FZI - Apparatus, Air Handling, Enclosure
DWL - Stocking, Medical Support (To Prevent Pooling Of Blood in Legs)
LZB - Finger Cot
KMJ – Lubricant, Patient
KMG - Purifier, Water, Ultraviolet, Medical
BRT - Restraint, Patient, Conductive
FMQ - Restraint, Protective
OYS - Patient Bed With Canopy/Restraints
LLN - Device, Vibration Threshold Measurement. This intention does not apply to devices that provide an interpretation or a clinical implication of the measurement.
LQW - Test, Temperature Discrimination. This intention does not apply to devices that provide an interpretation or a clinical implication of the measurement.
GWW - Ataxiagraph. This intention does not apply to devices that provide an
HCD - Cannula, Ventricular
GYK - Instrument, Shunt System Implantation
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
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
LZW – Monitor, Spine Curvature
IKO - Hammer, Reflex, Powered
ILJ - Bath, Hydro-massage
ILM - Bath, Sitz, Powered
IMC - Bath, Paraffin
ISD - Exerciser, Measuring
IRN - Device, Warning, Overload, External Limb, Powered



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