In the recent years medical device industry has experienced tremendous innovation and growth of more than 200 million medical devices in use worldwide. For those who seeks to bring medical device in U.S Market, this expansion also comes with pronounced risks and challenges, particularly on the legal front.
为了在美国市场上带来医疗设备可能是复杂的过程，这需要了解FDA要求和流程。需要考虑各种因素，其中包括医疗设备分类，前市场文件的准备和提交食品药物管理局。熟悉FDA的过程和不断变化的指导，可以帮助公司更轻松有效地推销设备。
The process for bringing medical device in U.S market:
以下步骤需要按照FDA的指导和法规遵循。
A] Determining US Classification:
美国食品药品监督管理局（FDA）对美国的医疗设备法规进行了控制 - 特别是，FDA的分支称为“设备与放射健康中心（CDRH）”将医疗设备分配给三个类别之一：
- I级（低到中等风险）：一般控制
- Class II (moderate to high risk): General controls and special controls
- Class III (high risk): General controls and premarket approval (PMA)
The Medical Device classification will decide type of submission required for clearance, so it is important to have a clear idea of your device class. Device classification has major impact on project timeline and cost.
最多I类设备免于预先提交的预先提交，但是仍然需要510（k）。
大多数具有豁免权的II类设备将在营销设备之前从FDA中提交510（k）。您需要表现出很大的等价“predicate device.”As aFDA 510(k) clearance consultant我们正在指导我们的客户制作档案。
III类设备将需要前市场批准申请（PMA）。对于那个公司，需要完成临床试验。FDA将使用此数据来确定设备的安全性和有效性。
One additional way which is gaining popularity amongst device makers is “De Novo pathway”。This is another way for obtaining market approval for Class I and II devices in the US. Only eligible devices are considered “novel” and must not listed on FDA classifications. For qualification of this pathway the device must also be considered low or moderate risk.
So how will you determine the classification of your specific device in U.S?
FDA产品分类数据库是确定设备特定分类的绝佳资源。在FDA产品分类数据库中，您可以按产品代码，设备名称，评论面板等进行搜索。从该搜索中获得的结果将为您提供大量信息，这些信息将有助于制定一种对您的产品有意义的监管策略。
b]标识正确的上市提交：
I类：设备很简单，对用户的风险很小。它们受医疗设备的一般监管控制和不需要任何上市上的提交。
II类：class II devices possess moderate level of risk andall of them require a premarket notification (510(k) submission) before legally marketing。诸如怀孕测试套件，静脉注射套件，缝合线和电动轮椅等设备可能会属于这一类别。这些设备对于医疗保健至关重要，但是它们的故障不太可能对患者造成严重伤害。
Class III:These devices include implantable pacemaker, blood vessel stents, or another implanted device etc. class III devices are categorized as highest risk for patients, as any problems with the device could lead to significant adverse outcomes for the patients.Class III devices require a PMA submission before being marketed in the USA.
The purpose of a 510(k) submission is to provide the FDA with documented evidence that your medical device is substantially equivalent to a predicate device which has been already been approved for marketing by the FDA. To prove the substantial equivalency, you’ll need to compare and contrast your device with the predicate device, and while laboratory testing is a typical requirement, human testing is usually not needed for 510(k) submissions. Information from your documented Design Controls process like intended use, indications for use, design inputs, and design verification are all required for your 510(k) submission.
The FDA processes 510(k) applications in 30-90 days. There can be an extended period of back-and-forth discussions, delaying the time to actual clearance in some of the cases. In PMA standards are much higher than 510(k) submissions, and the FDA has just 180 days to accept or reject the application. PMA is more detailed than a 510(k) – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.another option is the De Novo pathway,it is a classification process that uses a risk-based methodology for the approval of new and novel devices to be sold in the market. Companies using the De Novo pathway most of the time do not qualify for 510(k) clearance. Since companies not showing equivalence to a predicate device, they must be prepared to argue their robust risk mitigation strategy when submitting a De Novo request.
c]准备上市上提交。
为了预先提交，重要的是要知道必须包括哪些信息。根据您的开发人员的分类，设计控制，非临床测试，临床证据和标签都是要考虑的重要项目。在研究设计控制设计和开发计划时，应考虑优先级时考虑使用，设计输入，设计输出，设计验证，设计验证，设计更改和设计历史记录详细信息。
例如，较高的风险设备需要更详细的信息风险管理。风险规划以及风险评估数据以及包括临床和可用性数据在内的详细信息，然后降低风险设备，可以使用非临床性能数据和基准测试信息清除。
D] Submission to the FDA。
After the information is compiled, it must be submitted to the FDA for review and include an electronic copy. In the case of a 510(k) or PMA submission associated fee is required. The FDA will then conduct an administrative review to determine whether the submission is sufficiently complete. The FDA review time varies from 90-180 days, based on the device class and premarket submission type.
E]建立登记和设备清单。下一步是注册设备的建立ishment and list with the FDA, after premarket approval is granted. Obtaining clearance on a 510(k) does not necessarily give you the permission to start selling your product. Companies need to register their medical device and/or facility in the different countries they had like to sell. The FDA requires companies involved in the production and distribution of medical devices to register annually with the FDA. Additionally, many countries throughout the world require registration or licensing to sell your product within their borders. Your selected distributor can be a great source for learning more about registration in different countries.
F] Post market Surveillance:
为了在美国的营销后监视，FDA建立了Med-Watch（FDA安全信息和不良事件报告计划），该门户网站旨在促进PMS。在此门户医疗设备上，开发人员可以提交任何故障，报告的风险，不合格事件的报告，这些事件可能在使用设备期间发生。FDA还进行了独立的市场监视。
Bringing a medical device in U.S market is not easy task. It can be surprisingly multifaceted as well as complex for new device developers. However, by implementing a strategic plan from the start, medical device companies can eliminate a lot of stress and uncertainty from your process and increases chances for success in bringing your medical device to market. The medical device market in the United States offers great opportunity so that companies can easily navigate the many requirements and multiple-step process. Understanding the process can help during submission process as well as for bringing medical device in U.S market more effectively. As a医疗设备监管顾问, we are providing assistance to manufacturer at every step。
