On August 1, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.”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The draft guidance lists over 100 product codes of devices that FDA proposes to exempt from 510(k) requirements, which we have listed at the end of this blog.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: https://www.registrarcorp.com/livehelp.
FDA plans to exempt the following products from 510(k) requirements:
- 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 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
- 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. If device contains software to analyze clinical implication of the measurement, a 510(k) will be required.
- LQW – Test, Temperature Discrimination. If device contains software to analyze clinical implication of the measurement, a 510(k) will be required.
- GWW – Ataxiagraph. If device contains software to analyze clinical implication of the measurement a 510(k) will be required.
- 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