使用Product Classification数据库查询886.4150。 https://www.accessdata.fda.gov/s/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm 发现其中有6个Produce Code。 再点开具体介绍,看看自己的产品与哪个Product Code相符合。比如,第一个HKP。 打开可以发现更细节信息。比如:提交方式 Submission Type(510K),GMP豁免(No),第三...
使用Product Classification数据库查询886.4150。 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm 发现其中有6个Produce Code。 再点开具体介绍,看看自己的产品与哪个Product Code相符合。比如,第一个HKP。 打开可以发现更细节信息。...
The submission does not include the VAI or the NAI CGMP classification letter issued by FDA. 提交的材料不包括 FDA 发布的 VAI 或 NAI CGMP 分类信。 RESPONSIBILITIES职责 OGD Responsibilities OGD 职责 The Office of Regulatory Opera...
FDA determines that the words “Facility-Only Reclassification Request” are included in the submission and verifies that the submission includes the voluntary action indicated (VAI) or the no action indicated (NAI) current good manufacturing practice (CGMP) classification letter issued by FDA to the ...
Expansion of the electronic gateway across all human pharmaceutical and biologics submission types requires a phased approach and is expected to be completed at the end of 2016. In addition to the common gateway, both FDA and Health Canada are looking to increase mutual reliance on each other’s...
使用Product Classification数据库查询886.4150。 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm 发现其中有6个Produce Code。 再点开具体介绍,看看自己的产品与哪个Product Code相符合。比如,第一个HKP。 打开可以发现更细节信息。比如:提交方式 Submission Type(510K),GMP豁免(No)...
12、.181 and marketing submission requirements. thus, manufacturers of exempt class i devices are encouraged to use 820.30, design controls, as guidance.qs 规章 820.30 部分设计控制适用于产品设计以及对现有设计和工艺进行的加工和改变。即使原有设计不需遵守设计控制要求,对这些设计做出的更改仍需遵守设计控...
such as submissionnumbers for a prior not substantially equivalent (NSE)determination, prior deleted or withdrawn 510(k), Q-Submission,Investigational Device Exemption (IDE) application, premarketapproval (PMA) application, humanitarian device exemption (HDE)application, or De Novo classification request....
Studies Involving Investigational Devices FDA’s inspection of clinical investigators conducting foreign trials includes device trials in support of a premarket approval application (PMA) or a premarket notification (510(k)) submission. For device studies conducted outside the U.S., FDA will accept ...
In order to address this aspect of the special control, your 510(k) submission should address the elements described below. FDA will evaluate whether your plan will help to mitigate the risks presented by the device to offer reasonable assurance of the safety and effectiveness of the device and...