Medical devices undergo frequent modifications to their design and materials due to many things; changes in the supply chain, continuous process improvement, or to keep pace with technological innovations that can improve how these devices work in a clinical setting. Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.

醫療器械由于多方面的原因，其設計和材料需要經(jīng)常修改;供應鏈的變化，持續的流程改進(jìn)，或者跟上技術(shù)創(chuàng )新的步伐，這些創(chuàng )新可以改善這些設備在臨床環(huán)境中的工作方式。
對設備的重大修改可能需要FDA的上市前審查，而小的修改可能不需要。

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

可能需要新510(k)的修改示例包括但不限于以下內容:

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

從處方用藥到非處方用藥適應癥的改變

Addition of a new patient population

增加新的患者群體

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

使用環(huán)境的變化，例如從專(zhuān)業(yè)使用到家庭使用或醫院使用或到流動(dòng)運輸

Changes in frequency or duration of use

使用頻率或使用持續時(shí)間的變化

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

更改為指示與先前清除的設備不兼容的設備、組件或附件類(lèi)型的兼容性

Changes in sterilization, cleaning or disinfection

滅菌、清潔或消毒方面的變化

Changes in package integrity or shelf-life claims

包裝完整性或貨架有效期（保質(zhì)期）聲明的變化

Changes in device design

器械設計的變化

Changes to employ wireless communication

采用無(wú)線(xiàn)通信的變化

Changes in the human factors of the patient or user  interface

患者或用戶(hù)界面的人為因素的變化

A change in material type, formulation or chemical composition

材料類(lèi)型、配方或化學(xué)成分的變化

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

體外診斷(IVD)設備的抗體、檢測試劑、關(guān)鍵反應組分或偶聯(lián)物的變化