Regulatory Focus™ > News Articles > 107 Types of Medical Devices to be Given Regulatory Exemptions Under New FDA Proposal

107 Types of Medical Devices to be Given Regulatory Exemptions Under New FDA Proposal

Posted 01 August 2014 | By Alexander Gaffney, RAC

107 Types of Medical Devices to be Given Regulatory Exemptions Under New FDA Proposal

The US Food and Drug Administration (FDA) announced Thursday its intent to exempt dozens of medical devices from its premarket notification (also known as 510(k)) regulations.

Background

During the 2012 negotiation of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA committed to proposing (within two years) low-risk medical devices which could be exempted from premarket notification. (See FDA's Commitment Letter here)

But what does FDA mean by "exempt from premarket notification," exactly?

Under FDA's device regulation scheme, most products reach the market in one of three ways:

  • through a premarket approval (PMA) application requiring the submission of clinical data supporting a product's safety and efficacy
  • a premarket notification [510(k)] relying upon an already-approved predicate device, to which the new device claims to be substantially equivalent
  • devices which are exempted by FDA because they meet established standards recognized by FDA, or because they are recognized as low-risk, safe and effective devices. These devices must still be listed with FDA and adhere to good manufacturing practices and labeling requirements.

Accordingly, if a device is "exempted from premarket notification," that means that FDA is allowing a device that was previously required to submit a 510(k) application to simply be marketed without a review, provided all other regulatory requirements are met.

New Guidance

And, as promised, FDA is now out with a new guidance that grants exemptions to dozens of devices.

The guidance, Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements, is intended to allow products which are "sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness."

The guidance includes exemptions for the following 107 medical devices (and codes):

Device CodeDevice Type
BSIPowered Algesimeter
MRQAnalyzer, Nitrogen Dioxide
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
JAXPneumotachometer
CCOBed, Rocking, Breathing Assist
BTICompressor, Air, Portable
DRCTrocar
OCRLung Sound Monitor
DRZOscillometer
MNWAnalyzer, Body Composition
EATTester, Pulp
EHRPad, Denture, Over The Counter
EHSCushion, Denture, Over The Counter
EBPReliner, Denture, Over The Counter
ELMDenture, Plastic, Teeth
EKODenture Preformed (Partially Prefabricated Denture)
ELSSplint, Endodontic, Stabilizing
EGIParallelometer
KKORing, Teething, Fluid-Filled
ETWCalibrator, Hearing Aid / Earphone And Analysis System
EPFHearing Aid, Group And Auditory Trainer
KHLHearing Aid, Master
ETCMold, Middle-ear
FCWLight Source, Fiberoptic, Routine
GCTLight Source, Endoscope, Xenon Arc
NTNLed Light Source
FCSLight, Catheter, Fiberoptic, Glass, Ureteral
EZPRod, Colostomy
FHNLigator, Hemorrhoidal
MNDLigator, Esophegeal
LQCLithotriptor, Biliary Mechanical
EZOUrethrotome
MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female
EZMDilator, Esophageal (Metal Olive) Gastro-urology
FATBougie, Esophageal, And Gastrointestinal, Gastro-urology
KNQDilator, Esophageal
NIHDisinfectant, Subsystem, Water Purification
EXDIrrigator, Ostomy
LKBPad, Alcohol, Device Disinfectant
OVRKit, First Aid, Talking
ERYDrape, Surgical, Ent
EYXDrape, Pure Latex Sheet, With Self-retaining Finger Cot
EYYDrape, Urological, Disposable
FNWPad, Kelly
HMTDrape, Patient, Ophthalmic
HMWDrape, Microscope, Ophthalmic
KGWRing (Wound Protector), Drape Retention, Internal
KKXDrape, Surgical
FSQLight, Surgical, Instrument
FSSLight, Surgical, Floor Standing
FSWLight, Surgical, Endoscopic
FSXLight, Surgical, Connector
FSYLight Surgical, Celling mounted
FSZLight, Surgical, Carrier
FTDLamp, Surgical
FTGIlluminator, Remote
FQPLamp, Operating-room
GBClamp, Surgical, Incandescent
FZGApparatus, Air Handling, Bench
FZHApparatus, Air Handling, Room
FZIApparatus, Air Handling, Enclosure
FLLThermometer, Electrical, Clinical
DWLStocking, Medical Support (To Prevent Pooling Of Blood in Legs)
LZBFinger Cot
KMGPurifier, Water, Ultraviolet, Medical
BRTRestraint, Patient, Conductive
FMQRestraint, Protective
LLNDevice, Vibration Threshold Measurement
LQWTest, Temperature Discrimination
GWWAtaxiagraph
GWOPlate, Cranioplasty, Preformed, Alterable
LHDDevice, Fertility Diagnostic, Proceptive
HFLDrain, Cervical
HDAForceps, Obstetrical
HIBSpeculum, Vaginal, Nonmetal
HFWClamp, Umbilical
OOAHemorrhoid, Prevention, Pressure, Wedge
HGZHeater, Perineal, Direct Contact
HHAHeater, Perineal, Radiant, Non-contact
KNDHeater, Perineal
HHECup, Menstrual
NUQPad, Menstrual, Reusable
KXQVibrator For Therapeutic Use, Genital
HKICamera, Ophthalmic, AC-powered
MMFPhotorefractor
HMKEuthyscope, AC-powered
HJMTransilluminator, AC-powered
HLDEngine, Trephine, Accessories, Gas-powered
HOGBurr, Corneal, Battery-powered
HRFEngine, Trephine, Accessories, Battery-powered
HRGEngine, Trephine, Accessories, AC-powered
HQSBurr, Corneal, AC-powered
HROUnit, Electrolysis, AC-powered, Ophthalmic
FCTHeadlight, Fiberoptic Focusing
FSRLight, Headband, Surgical
HPQHeadlamp, Operating, AC-powered
HPMLocator, Metal, Electronic
HPOMagnet, AC-Powered
HOZSponge, Ophthalmic
IKOHammer, Reflex, Powered
LQXDevice, Finger-sucking
ILJBath, Hydro-massage
ILMBath, Sitz, Powered
IMCBath, Paraffin
ISDExerciser, Measuring
IRNDevice, Warning, Overload, External Limb, Powered

 

Comments on the guidance are due by 30 September 2014.

 

Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements (FR)


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