FC2ブログ

EMC、安全規格、エネルギー効率等の情報


FDA、510(K)要件から120種類の医療機器を免除

米国・カナダ ] 2015/09/19(土)

2015年7月1日、米国食品医薬品局(FDA)は、510(K)(市販前通知)要求を免除する120種類の医療機器のリストを発表しました。
以下は、リストです。
1.Anesthesiology Devices(麻酔機器)
 ・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
2.Cardiovascular Devices(心血管機器)
 ・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
3.Ear, Nose & Throat Devices(耳、鼻&喉機器)
 ・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
4.Gastroenterology - Urology Devices(消化器 - 泌尿器科機器)
 ・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
5.General Hospital and Personal Use Devices(総合病院、及び個人利用の機器)
 ・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
6.Neurological Devices(神経機器)
 ・LLN - Device, Vibration Threshold Measurement
 ・LQW - Test, Temperature Discrimination
 ・GWW - Ataxiagraph
 ・HCD - Cannula, Ventricular
 ・GYK - Instrument, Shunt System Implantation
7.Obstetrical and Gynecological Devices(産科、及び婦人科機器)
 ・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
8.Ophthalmic Devices(眼科機器)
 ・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
9.Physical Medicine Devices(物理療法機器)
 ・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
07:25 | トラックバック:0 | コメント:0 | 先頭 | TOP



トラックバックURLは http://firstspring.blog.fc2.com/tb.php/191-a0848d46

トラックバック


コメント


コメントの投稿
管理者にだけ表示を許可する

| このページの先頭へ |

プロフィール

湘南次郎

Author:湘南次郎
(1)電気・電子機器メーカにて「電子機器」設計、及び「EMC・安全規格」適合取得に従事し、効率的な規格適合を支援してきました。
(2)国内(VCCI、PSE)、欧米(CE、UL)、アジア(CCC等)の規格適合に関して、アドバイスを行ってきました。

おすすめ

最新トラックバック

検索フォーム

ブロとも申請フォーム

QRコード

QR