FDA更新“预期豁免510K要求的产品清单”_进口医疗器械注册_国产医疗器械注册_一二三类医疗器械产品注册备案专业代办外包公司|道和思源
欢迎访问道和思源(北京)科技有限公司
15601091052
当前位置:主页 > 新闻资讯 > 行业动态 >

FDA更新“预期豁免510K要求的产品清单”

发布日期:2020-05-09 浏览次数:


美国FDA201481发布了预期豁免部分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.

FDA201571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

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
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


15601091052

扫微信直接咨询