特殊510K-需要提交的文件

圈圈123

想问一下，1产品想加个型号，原理适用范围都没变，就其中一个部件由主体内放到外面了。是要走特殊510K吗。走完特殊510K新旧型号是有俩K号吗。列示后，之后是都可以上市售卖是吗。

2还要特殊510K-需要提交的文件不知道表格中的是否全面，理解是对的吗。第5点 “ Clean and redlined copies of documents that were updated from what was submitted in the predicate device’s submission because of the device change (e.g., labeling, risk analysis);”是必须要有的吗，所有文件都标示吗。
我参考的文件是 The special 510K program

序号	具体内容	解读内容
1.	·Cover letter“Special 510(k): Device Modification;”	封面信，写明“Special 510(k): Device Modification;”
2.	·The name of the manufacturer’s legally marketed (existing) device and the 510(k) number	制造商合法销售的（现有）设备的名称和510（k）号
3.	·A detailed description of the change(s) made to the device that resulted in the submission of a new 510(k)	器械所做的改变的详细描述
4.	·A comparison of the modified device to the cleared device in a tabular format	以表格的形式对修改后的器械与已批准的器械进行比较
5.	·Other changes to labeling or design(i.e., those that did not require submission of a new 510(k)) When labeling or specific technolo gical characteristics (e.g., materials, dimensions) are unchanged in comparison to the predicate, the submission should clearly state that no changes were made;	对标签或设计的其他改动（即，那些无需提交许可证的变化） 当标签或具体的技术特征（如材料、尺寸）与原件相比没有变化时，提交的材料应明确说明没有变化。
6.	Clean  and redlined copies of documents that were updated from what was submitted in the predicate device’s submission because of the device change (e.g., labeling, risk analysis);	文件更新部分标示出来
7.	·A concise summary of the design control activities(such as risk analysis)	设计控制活动的简明摘要表格
8.	·Based on the risk analysis, an identification of the verification and/or validation activities required to comply with 21 CFR 820.30（including a summary of test methods, acceptance criteria, and results, and why each is adequate to support substantial equivalence）	根据风险分析，确定符合21 CFR 820.30要求的验证和/或确认活动（包括测试方法、验收标准和结果的总结，以及为什么 每一项都足以支持实质上的等同性）
9.	·Indications for Use form (Form FDA 3881)	使用适应症表（FDA 3881表）
10.	·A signed statement on design controls activit A statement that the submitter has complied and is not currently in violation of the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review upon request	一份声明，说明提交者已经遵守并且目前没有违反21 CFR 820.30中规定的设计控制程序要求，并且记录可供要求时审查