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【新动态】FDA发布510(k)快速审核流程

9月6日,美国FDA发布了510(k) 快速审核流程。这个流程的目的是为了简化制造商递交中等风险医疗器械510(k)的流程以及评估使用FDA的免费e-submitter软件是否能提高审核效率。

在这个流程之前,制造商在申请510(k)时,需要同时递交纸质版和电子版的资料。而快速审核流程允许制造商使用FDA的免费e-submitter软件输入510(k)申请所需要的所有信息,并将完整的文件保存在CD, DVD或者U盘中。制造商只需要将电子版的资料发送给FDA的文控中心,而不需要同时递交纸质版和电子版。

另外,符合快速审核流程的510(k)没有行政审核,而是直接进入交互审核的阶段。FDA会在60天内做出最终的决定。快速审核流程并不会改变任何决定实质等同的要求。

目前并不是所有的产品都可以走快速审核通道,符合快速审核流程的器械必须同时满足以下的标准:

  1. 器械的产品编码必须出现在符合快速审核流程的产品清单中(见本文末)

  2. 器械不是联合产品(如药械联合产品或生物制品器械联合产品)

  3. 产品的主要审核中心为FDA的器械和辐射健康中心(CDRH)

  4. 非体外诊断器械

不符合以上任一标准的器械,需要按照传统的方式来递交510(k)。如果递交者仍坚持以e-submission的方式递交资料,则会被拒。

符合快速审核流程的器械的产品清单:

Regulation

Product code

Description

880.2910   Clinical electronic thermometer

FLL

Electronic   thermometer

880.557   Hypodermic single lumen needle

FMI

Hypodermic   single lumen needle

870.1875   Stethoscope

DQD

Electronic   Stethoscope

870.1250   Percutaneous catheter

DQY

Percutaneous   Catheter

870.1310   Vessel dilator for percutaneous catheterization

DRE

Vessel   Dilators

870.2900   Patient transducer and electrode cable (including connector)

DSA

Cable,   Transducer And Electrode, Patient, (Including Connector)

870.4450   Vascular clamp

DXC

Vascular Clamps

870.1650   Angiographic injector and syringe

DXT

Angiographic   Syringes

870.1340   Catheter introducer

DYB

Catheter   Introducer

870.5800   Compressible limb sleeve

JOW

Compressible   limb sleeve

870.1650   Angiographic injector and syringe

MAV

Syringe, Balloon   Inflation

870.4885   External vein stripper

MGZ

Valvutome

882.1320   Cutaneous electrode

GXY

Cutaneous   electrode

890.3850   Mechanical wheelchair

IOR

Mechanical   wheelchair

890.5650   Powered inflatable tube massager

IRP

Massager,   powered inflatable tube

888.3030   Single/multiple component metallic bone fixation appliances and accessories

LRN

Surgical wire

888.3030   Single/multiple component metallic bone fixation appliances and accessories

LYT

Fixation   accessory

888.3050   Spinal interlaminal fixation orthosis

NQW

Orthosis,   Spine, Plate, Laminoplasty, Metal

874.1050   Audiometer

EWO

Audiometer

886.1850   AC-powered slitlamp biomicroscope

HJO

Biomicroscope,   Slit-Lamp, Ac-Powered

886.1120   Ophthalmic camera

HKI

Ophthalmic   camera, AC powered

886.1780   Retinoscope

HKL

Retinoscope,   Ac-Powered

886.4370   Keratome

HMY

Keratome,   Battery-Powered

886.4370   Keratome

HNO

Keratome,   Ac-Powered

886.4670   Phacofragmentation system

HQC

Unit,   Phacofragmentation

874.3400   Tinnitus masker

KLW

Tinnitus   masker

886.5928 Soft   (hydrophilic) contact lens care products

LRX

Case, Contact   Lens

unclassified

LXQ

Cup, Eye

unclassified

OKS

Lacrimal   Stents and Intubation Sets

876.4500   Mechanical lithotripter

FGK

Tripsor,   stone, bladder

876.1500   Endoscope and accessories

FTI

Lamp,   endoscope, incandescent

876.1500   Endoscope and accessories

OCZ

Endoscopic   grasping/cutting instrument, non-powered

876.1500   Endoscope and accessories

GCJ

Laparoscope,   General & Plastic Surgery

878.4810   Laser surgical instrument for use in general and plastic surgery and in   dermatology

GEX

Powered laser   surgical instrument

890.5500   Infrared lamp

OAP

Laser, comb,   hair

892.1000   Magnetic resonance diagnostic device

MOS

Coil,   magnetic resonance, specialty

892.1680   Stationary x-ray system

MQB

Solid state   x-ray imager (flat panel/digital imager

892.2050   Picture archiving and communications system

PGY

Display,   diagnostic radiology


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