以下幾種情況下需要做FDA510(K) 變更   

A change in indications for use from prescription      use to over the counter use

Addition of a new patient population

Changes to the environment of use such as from      professional use to home use or hospital use to ambulatory transport

Changes in frequency or duration of use

Change to indicate compatibility with a type of      device, component, or accessory that was not indicated as compatible with      the previously cleared device

Changes in sterilization, cleaning or disinfection

Changes in package integrity or shelf-life claims

Changes in device design

Changes to employ wireless communication

Changes in the human factors of the patient or user   interface

A change in material type, formulation or chemical      composition

Changes in the antibody, detection reagents,      critical reaction components or conjugates for in vitro diagnostic (IVD)      devices

更多美國FDA醫(yī)療器械產(chǎn)品注冊備案常見問題及方案解決請聯(lián)系深圳市思博達(dá)彭先生或登錄公司網(wǎng)站www.bccgd.com。

深圳市思博達(dá)管理咨詢有限公司是一家從事醫(yī)療器械國際咨詢的專業(yè)性咨詢機(jī)構(gòu)。提供各個國家或地區(qū)醫(yī)療器械注冊認(rèn)證，包括中國NMPA、美國FDA、510(K)、歐盟MDR CE認(rèn)證、加拿大MDL認(rèn)證、澳洲TGA認(rèn)證等等、醫(yī)療器械質(zhì)量體系審查，如中國醫(yī)療器械GMP（包括試劑類）、美國QSR820質(zhì)量體系場考核、歐盟GMP、日本GMP、巴西GMP、ISO13485等）等多種國際注冊及認(rèn)證的咨詢、代理服務(wù)；也可為您提供醫(yī)療器械風(fēng)險管理、軟件確認(rèn)、滅菌確認(rèn)、臨床評估、可用性確認(rèn)等專題培訓(xùn)服務(wù)。