510（k）s的医疗设备收益和风险分析
与申请人设备的安全性和功效相关，FDA将考虑“使用该设备对健康的任何可靠利益，而不是其他适用因素，从而抵抗这种使用的任何潜在创伤或疾病的风险”。FDA最近发布了最终指南，标题为“在确定实质性等价性时要考虑的利益风险因素Premarket Notifications 510(k)具有对比的技术特征。”该指南旨在帮助申请人证明具有实质性的等效性，并在新设备的福利风险分析概况与谓词设备的福利风险分析概况时提供指导。
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.
该指南始于对实质对等分析的高级审查，并指出它始于寻求清除设备是否与谓词设备相同的预期用途的问题。如果是这样，那么FDA会考虑这两个设备是否具有“相同的技术特征”，或者技术特征上的任何差异是否会引起安全性和有效性的问题，以及竞争者设备至少与谓词设备一样安全和生产力。
Advantage and threat may be spotted from performance data, which can be non-clinical or clinical. A device with less benefit compared to the predicate may be found considerably equivalent if it also presents less risk; conversely, a device with increased risks compared to the predicate may be found considerably equivalent if it also offers greater benefits.
The guidance then identifies and seeks to clarify the advantage and risk factors it considers if it has determined that any different technological characteristics do not raise different questions of safety and effectiveness. The factors that the FDA will consider include:
- Classes of benefit(s)– samples include the device’s clash on clinical process, patient health, and patient fulfilments in the target population, such as the result on patient process and quality of life, probability of survival, up-gradation of patient’s function, prevention of loss of function, and relief from manifestation of any disease.
- The magnitude of the benefit(s)
- The expectation of the patient experiencing one or more benefit(s)
- 效果持续时间
The FDA also examines several risk factors individually and in the quantity:
- 与使用设备相关的有害事件的肢体，类型，数量和速率
- 与设备有关的严重不良事件
- Device-related non-serious adverse events
- Procedure-related complications
- 有害事件的前景
- 患者经历一个或多个有害事件的前景
- The time span of harmful events
- Probability from false-positive or false-negative results for diagnostics
- The number of different types of harmful events that can potentially result from using the device and the extremity of their aggregate effect
该指南还确定了FDA在评估申请人设备的安全性和有效性时检查的许多“其他因素”，包括以下内容：
- Uncertainty– the degree of certainty of the benefits and risks of the device
- Classification of the disease/condition– the disease/condition, its clinical display, how it affects the patients who have it, how and whether a diagnosed disease/condition is healed, and the condition’s natural history and progress.
- Innovative Technology- when a new device has technological improvements that are important for public health, the FDA may accept greater uncertainty in an assessment of benefits and risks
- Patient sufferance for risk and standpoint on benefit
- Benefit for the healthcare professional or caregiver– the FDA recognizes that certain devices, such as surgical tools that allow different techniques or devices that positively affect ongoing patient management, may improve the way they care for the patients and consequently improve patient outcomes
- 降低风险 - 缓解措施可能最小
- Postmarket data – provides a greater perception of risks and advantages of the device itself and the risks and advantages of similar devices
最终，该指南讨论了这些各种因素实施的许多具体示例。
The FDA’s guidance official papers do not establish legally execute responsibilities, as always but rather describe the FDA’s current thinking on a topic.
