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FDA更新“預(yù)期豁免510K要求的產(chǎn)品清單”

發(fā)布時間：2015-07-17

美國FDA于2014年8月1日發(fā)布了“預(yù)期豁免部分II類和I類器械510K要求”草案指南。該草案指南在FDA器械數(shù)據(jù)庫的16個醫(yī)療器械板塊中，涉及的器械板塊有11個，共涉及107個產(chǎn)品編碼.

而FDA于2015年7月1號發(fā)布了“預(yù)期豁免部分II類和I類器械510K要求”最終指南。與原草案指南相比，涉及的器械板塊還是11個，但是涉及的產(chǎn)品編碼變?yōu)榱?20個（在原草案指南的基礎(chǔ)上增加了17個產(chǎn)品編碼，刪除了4個）。

下表是最終指南與草案指南相比增加和刪除的產(chǎn)品清單。

增加的產(chǎn)品編碼:

Device Panel	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
General Hospital and Personal Use Devices	OYS	880.6760	Patient Bed With Canopy/Restraints
Neurological Devices	HCD	882.4060	Cannula, Ventricular
Neurological Devices	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

刪除的產(chǎn)品編碼：

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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