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 Code | Device Type |
|---|---|
| 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 Assist |
| BTI | Compressor, Air, Portable |
| DRC | Trocar |
| OCR | Lung Sound Monitor |
| DRZ | Oscillometer |
| MNW | Analyzer, Body Composition |
| 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 |
| KKO | Ring, Teething, Fluid-Filled |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis System |
| EPF | Hearing Aid, Group And Auditory Trainer |
| KHL | Hearing Aid, Master |
| ETC | Mold, Middle-ear |
| 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, Esophegeal |
| 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 |
| FLL | Thermometer, Electrical, Clinical |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood in Legs) |
| LZB | Finger Cot |
| KMG | Purifier, Water, Ultraviolet, Medical |
| BRT | Restraint, Patient, Conductive |
| FMQ | Restraint, Protective |
| LLN | Device, Vibration Threshold Measurement |
| LQW | Test, Temperature Discrimination |
| GWW | Ataxiagraph |
| GWO | Plate, Cranioplasty, Preformed, Alterable |
| LHD | Device, Fertility Diagnostic, Proceptive |
| 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 |
| KXQ | Vibrator For Therapeutic Use, Genital |
| HKI | Camera, Ophthalmic, AC-powered |
| 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 |
| IKO | Hammer, Reflex, Powered |
| LQX | Device, Finger-sucking |
| ILJ | Bath, Hydro-massage |
| ILM | Bath, Sitz, Powered |
| IMC | Bath, Paraffin |
| ISD | Exerciser, Measuring |
| IRN | Device, 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)