以下几种情况下需要做FDA510(K) 变更   

深圳市思博达管理咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构。提供各个国家或地区医疗器械注册认证，包括中国NMPA、美国FDA、510(K)、欧盟MDR CE认证、加拿大MDL认证、澳洲TGA认证等等、医疗器械质量体系审查，如中国医疗器械GMP（包括试剂类）、美国QSR820质量体系场考核、欧盟GMP、日本GMP、巴西GMP、ISO13485等）等多种国际注册及认证的咨询、代理服务；也可为您提供医疗器械风险管理、软件确认、灭菌确认、临床评估、可用性确认等专题培训服务。

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

更多美国FDA医疗器械产品注册备案常见问题及方案解决请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。