美国FDA于2014年8月1日发布了“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.
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
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