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【新動態(tài)】FDA發(fā)布510(k)快速審核流程

發(fā)布時間:2018-09-13


9月6日,美國FDA發(fā)布了510(k) 快速審核流程。這個流程的目的是為了簡化制造商遞交中等風(fēng)險醫(yī)療器械510(k)的流程以及評估使用FDA的免費(fèi)e-submitter軟件是否能提高審核效率。


在這個流程之前,制造商在申請510(k)時,需要同時遞交紙質(zhì)版和電子版的資料。而快速審核流程允許制造商使用FDA的免費(fèi)e-submitter軟件輸入510(k)申請所需要的所有信息,并將完整的文件保存在CD, DVD或者U盤中。制造商只需要將電子版的資料發(fā)送給FDA的文控中心,而不需要同時遞交紙質(zhì)版和電子版。


另外,符合快速審核流程的510(k)沒有行政審核,而是直接進(jìn)入交互審核的階段。FDA會在60天內(nèi)做出最終的決定??焖賹徍肆鞒滩⒉粫淖?nèi)魏螞Q定實(shí)質(zhì)等同的要求。


目前并不是所有的產(chǎn)品都可以走快速審核通道,符合快速審核流程的器械必須同時滿足以下的標(biāo)準(zhǔn):

1.器械的產(chǎn)品編碼必須出現(xiàn)在符合快速審核流程的產(chǎn)品清單中(見本文末)

2.器械不是聯(lián)合產(chǎn)品(如藥械聯(lián)合產(chǎn)品或生物制品器械聯(lián)合產(chǎn)品)

3.產(chǎn)品的主要審核中心為FDA的器械和輻射健康中心(CDRH)

4.非體外診斷器械


不符合以上任一標(biāo)準(zhǔn)的器械,需要按照傳統(tǒng)的方式來遞交510(k)。如果遞交者仍堅持以e-submission的方式遞交資料,則會被拒。


符合快速審核流程的器械的產(chǎn)品清單:


 

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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