美國FDA201481發布了預期豁免部分II類和I類器械510K要求草案指南。該草案指南在FDA器械數據庫的16個醫療器械板塊中,涉及的器械板塊有11個,共涉及107個產品編碼.

FDA201571號發布了預期豁免部分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,但是涉及的產品編碼變為了120個(在原草案指南的基礎上增加了17個產品編碼,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品清單。

增加的產品編碼

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

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

刪除的產品編碼