如何用美国FDA数据库查询信息

蒲香01

对一个医疗器械从业人员来说，FDA网站绝对是一个宝藏库。比如在产品开发时搜索在美国上市的同类产品的技术申报资料的摘要，类似于目前中国国家药品监督管理局发布的产品《医疗器械产品注册技术审评报告》。区别在于，目前中国NMPA仅就个别产品发布该报告，而FDA将所有通过510(k), PMA和De Novo的产品都公开相关资料，经PMA路径审批的产品还会公开说明书和标签。

1、 FDA医疗器械的分类

FDA对医疗器械实行分类管理，根据风险等级和管理程度，分为三类（I，II，III）进行上市前管理。

I类产品为“普通管理（General controls）”产品，FDA对这类产品大多豁免了上市前通告程序（Pre-market Notification，PMN；即510(k)），通过登记管理，即可上市。

II类产品为“普通&特殊管理（General & Special Controls)”产品，这类产品基本上都需要进行510(k），才可上市销售。有极少数的一部分II类产品可以豁免510(k)。

III类产品为上市前批准管理（Pre-market Approval,PMA)产品，生产企业在产品上市前必须提交PMA申请和相关资料，证明产品符合要求。

除了以上三类外，全新的无已上市同类/相似产品的医疗设备则通过“De Novo”申请；进行分类判断并确定需要递交哪些材料。

2、如何检索FDA的数据库

A）通过医疗器械数据库检索

我们登陆FDA医疗器械部分，链接https://www.fda.gov/Medical-Devices找到数据库，进入产品对应的数据库搜索相关产品。

还有一个更方便的链接，

https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

这个链接包括了510(k)和PMA两个数据库（如下图），基本囊括了绝大多数的IVD产品。

B）通过分类检索

FDA对部分IVD产品还进行了分类总结，如伴随诊断产品，血糖监测产品，分子诊断产品等等，进入对应分类后，可以非常容易查到这个分类下的所有FDA获批的产品。

https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics

以分子诊断产品举例：点击进入后，可以看到如下的页面，产品进行了第二次分类，人基因检测产品和微生物类检测产品。

所有产品均按照疾病进行的分类，列明了该疾病所有FDA批准上市的诊断试剂，比如下图就是肝炎检测的相关分子诊断产品。

比如我们想了解美国批准上市的伴随诊断产品的情况，只需要进入“Companion Diagnostics”那一部分，就可以快速的对其有一个全面了解，而无需再一个个去搜索。

点击后面的510(k) Number 或PMA Number，可以直接链接到数据库，以上图第三个雅培的Alinitiy HCV举例，可以链接到如下界面。

这个界面和通过数据库检索得到的界面是相同的，可以看到，该产品是在2020年第一次获批，并提交了6次补充资料。进入对应的链接，就可以下载到相应的资料了。

hedison2

确实，图片看不到啊

似水鸭

牛啊牛啊  

asan16888

谢谢楼主分享！

姜新

好详细，赞赞赞👍

以北为诗

谢谢分享，学习一下

wuxue

谢谢楼主分享，在FDA数据库找到需要的了。

邹永胜

谢谢楼主分享！！！！

zhuhao668

全新的无已上市同类/相似产品的中低风险医疗设备则通过“De Novo”申请
原文如下，
FDA SUBMISSIONS
Several types of premarket submissions can be made to FDA. In order to legally market a device in the US, the most common forms of premarket submissions to FDA are the 510(k) premarket notification submission and the PMA premarket approval. Another lesser known premarket submission is the de novo submission. Each of these submission types result in a determination by FDA that clears [510(k)], approves [PMA], or grants [de novo] marketing rights to the successful submitter. Other submissions to FDA include Pre-submissions (Pre-subs), Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), and Master Files, to name a few. The most commonly made submissions are described in more detail below.

510(K) SUBMISSION  
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) submission to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in part .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices (predicates) and make and support their substantial equivalency claims. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S.

PMA
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the most stringent of the device marketing applications. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k). PMA applications will include technical sections, usually divided into non-clinical laboratory studies and clinical investigations. PMA approval typically requires a facility inspection to confirm compliance to 21 CFR 820 prior to approval.

DE NOVO
The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device. Upon successful review of a de novo submission, FDA creates a classification for the device, a regulation if necessary, and identifies any special controls required for future premarket submissions of substantially equivalent devices. Companies with novel devices of low to moderate risk have two options when considering the de novo pathway: the company can submit a 510(k) to the FDA, and upon receipt of a “Not Substantially Equivalent” determination, the de novo request can be made; or the company can submit a de novo request without first submitting a 510(k). Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

PRE-SUBMISSIONS (PRE-SUBS)
Pre-submissions are made to the FDA in order to request FDA feedback. Pre-subs are used for various reasons including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol. The main purpose of the Pre-Sub Program (previously known as the Pre-IDE Program) is to provide the opportunity for a sponsor to obtain FDA feedback prior to an intended submission of an IDE or marketing application. The Pre-Sub Program can also provide a mechanism for the Agency to provide advice to sponsors who are developing protocols for clinical studies for which an IDE would not be required, such as studies of non-significant risk (NSR) devices or for clinical studies conducted outside of the U.S. to support future U.S. marketing applications. Consequently, the Pre-Sub program can provide an efficient path from device concept to market while facilitating the agency’s goal of fostering the development of new medical devices.

甲方乙方

谢谢楼主分享，学习一下

JimmyKing

感谢前辈提携

小金库

谢谢分享!

Harrieth0d

谢谢分享，非常有用

15821890861

请教下化学原材料分析数据如何在FDA网站上查询

妖怪怪怪的

感谢分享！

青蛙怪兽

感谢楼主分享，牛哇

2097056249

谢谢楼主分享！

2097056249

顺便问一下哪个大佬知道怎么查到临床信息啊

Redamancyfyd

谢谢分享~很不错，进网站看了一下，东西有点多，慢慢学习实用