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FDA更新“预期豁免510K要求的产品清单”

美国FDA于2014年8月1日发布“预期豁免部分II类和I类器械510K要求”草案指南。该草案指南在FDA器械数据库的16个医疗器械板块中,涉及的器械板块有11个,共涉及107个产品编码.

而FDA于2015年7月1号发布了“预期豁免部分II类和I类器械510K要求”最终指南。与原草案指南相比,涉及的器械板块还是11个,但是涉及的产品编码变为了120个(在原草案指南的基础上增加了17个产品编码,删除了4个)。
下表是最终指南与草案指南相比增加和删除的产品清单。

增加的产品编码:

Product code

Regulation No.

Product name

Dental Devices

EIB

872.4565

Syringe, Irrigating (Dental)

Ear, Nose & Throat Devices

EWD

Unclassified

Protector, Hearing (Insert)

EWE

Unclassified

Protector, Hearing (Circumaural)

LEZ

Unclassified

Aids, Speech Training for the Hearing Impaired (AC-Powered and Patient-Contact)

LFA

Unclassified

Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-Patient)

KLX

874.1325

Electroglottograph

LZI

874.3320

Device, Assistive Listening

Gastroenterology- Urology Devices

LRL

Unclassified

Cushion, Hemorrhoid

General Hospital and Personal Use Devices

KMJ

880.6375

Lubricant, Patient

OYS

880.6760

Patient Bed With Canopy/Restraints

Neurological Devices

HCD

882.4060

Cannula, Ventricular

GYK

882.4545

Instrument, Shunt System Implantation

Obstetrical and Gynecological Devices

LHM

884.2982

System, Thermographic, Liquid Crystal

KYA

884.2982

System, Thermographic Liquid Crystal, Nonpowered (Adjunctive Use)

NUR

884.5435

Pad, Menstrual, Reusable

Ophthalmic Devices

PJZ

886.1120

Camera, Ophthalmic, AC-Powered, General-Use

Physical Medicine Devices

LZW

886.1120

Monitor, Spine Curvature

删除的产品编码:

Device Panel

Product code

Regulation No.

Product name

General Hospital and Personal Use Devices

FLL

880.2910

Thermometer, electronic, clinical

Neurological Devices

GWO

882.5320

Plate,Cranioplasty, reformed, Alterable

Ophthalmic Devices

HKI

886.1120

Camera, Ophthalmic, AC-powered

Physical Medicine Devices

LQX

890.3475

Device, Finger-sucking

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