For Classifying a Class III Medical Device the FDA established certain regulatory controls in the form of general controls and special controls. The classification of medical devices (Class I, Class II or Class III) will determine the type of regulatory controls the FDA imposes to ensure the device’s safety and effectiveness before being placed into commercial distribution in the US.
当涉及到每个FDA要求的医疗设备分类时，它实际上归结为产品带来的利益和风险以及确保足够安全所需的控制水平。I类设备对患者的危害最小，通常在设计上很简单，而II类构成更高的风险。对III类医疗设备进行分类适用于认为对健康或维持生命非常重要的高风险医疗设备。
- Operon Strategist isFDA 510 k process consultanthelps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
- We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.
FDA 510 k Clearance & Premarket Approval for Medical Device
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.
更具体地说，对III类医疗设备进行分类是一般和特殊控制不足以建立安全性和功效的设备。这些设备属于三类之一：用于支持或维持人类生活的三类之一。在防止人类健康受损方面非常重要。出现潜在的疾病或伤害的不合理风险。
对III类医疗设备进行分类遵循严格的控件，其中大多数需要预批准（PMA）提交或从头提交。为了将医疗设备分类为III类，制造商需要经历严格的PMA过程，该过程通常涉及临床试验和数据收集。
The only exceptions to the PMA process within Class III are devices with a substantial equivalent. You can determine whether a Class III device can be marketed with a 510(k) by searching the FDA Premarket Approval (PMA) database and the 510(k) Premarket Notification database. De Novo comes into play in the case of a low to medium risk novel device for which there is no legally marketed predicate device. These devices are automatically designated a class III, regardless of risk level. Through the De Novo, the FDA offers an alternate pathway to classify a medical device down to a class I or class II. Once the device is down-classified and approved via the De Novo pathway, it can be used as a predicate for subsequent submissions.
无论需要进行III类医疗设备的特定分类，如果需要清除或批准，则必须对临床研究进行两种方法之一：
- If it poses a Significant Risk (SR), it must follow the FDA’s Investigational Device Exemption (IDE) protocol
- If it does not pose a significant risk, it will go before an Investigational Review Board
Examples of the types of medical devices that fall under class III include:
- Cochlear implants
- Implantable pacemaker pulse-generator
- Renal stents
- 可穿戴的自动化外部除颤器
- High frequency ventilators
For Classifying a Class III Medical Device, the manufacturer will undergo the highest level of FDA scrutiny and associated costs. The majority of devices are considered a class I or class II, with only 10% receiving the class III designation.
由于以下原因，了解您的医疗设备的分类如何：
- Product classification will determine what you have to do before you can sell your product.
- Product classification will help you establish requirements during the product development phase, specifically design controls.
- Product classification is an important component in determining how much it will cost to bring your device to market and give you some idea of how long it will take.
Class III Medical Devices
- In that class, all medical devices have the highest risk possible, and permanent monitoring is required during their lifetime.
- 有专门的机构负责进行产品的监视。
- 例如，这种设备是心血管导管，动脉瘤夹，髋关节植入物，人体心脏瓣膜等。
- 在这里，在II类中，医疗设备的合格评估可能包括对技术文档和质量系统/产品检查的审核，并专注于设备设计和生产的一个或多个方面。
III类医疗设备是那些对患者和/或用户具有高风险的设备。这些设备通常维持或支持寿命，植入或出现潜在的疾病或伤害风险。它们代表了由FDA调节的10％的医疗设备。III类设备的例子包括可植入的起搏器和乳房植入物。
