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医疗器械哪些变更不需要提交新的510(K)

更新时间:2024-09-19 07:10:00
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详细介绍

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) re is significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device。


As to the detail is following


Labeling changes

Technology, engineering, and performance changes

Materials changes

Technology, engineering, performance, and materials changes

Considerations for risk-based assessments of modified devices


Examples of modifications that may require a new 510(k) include, but are not limited to, the following:

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

  • Addition of a new patient population

  • Changes  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


深圳思博达医疗技术服务有限公司(Shenzhen Bosstar Consult Company Limited,简称BCC)凭借100余个医疗器械注册认证成功案例经验,为国内外医疗器械公司,科研机构、个人提供: 二、三类医疗器械注册证、生产许可证,经营备案证、经营许可证,产品备案证、生产备案证办理,注册人研发、委托生产,产品注册检验,临床试验CRO,医疗器械质量体系 、法规,GMP现场考核、ISO13485 、QSR820、MDSAP的推行, 欧盟CE MDR 745/2017 注册,美国FDA : I 类备案列名、II类510K注册 、III类PMA注册等“一站式”服务。


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