FDA had released draft guidance for identification tags that will track medical devices from manufacturers to users. The guidelines come as the number of medical devices required to meet the tracking regulations has expected to grow this fall.
当制造商从制造商那里收到订单时Food and Drug Administration(FDA) to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.
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.
联系我们 WhatsApp制造商必须采用一种跟踪设备的方法，其失败可能会造成严重的，不利的健康后果；或打算在人体中植入超过一年；或者是在设备用户设施之外使用的维持生命或维持生命支持的设备。实施跟踪要求的规定于1993年8月29日生效，可以在21 CFR Part 821.
On the effective day i.e on February 19, 1998, the tracking requirement was changed to eliminate automatic mandatory tracking for certain devices; instead has discretion to order manufacturers of certain types of Class II or Class III devices to initiate a program to track their medical devices down to the patient level.
有关实施的信息医疗设备跟踪Regulation along with a list of devices that FDA has ordered to be tracked can be found in the following guidance “医疗设备跟踪– Guidance for Industry and Food and Drug Administration Staff“. Please note that 21 CFR 821 does not contain the current list of devices to be tracked. The list may be found in the guidance document referenced above and at the bottom of this page. The list in the guidance document may notreflect devices newly identified as needing to be tracked, since the last time the guidance document was updated.
The tracking provision is intended to ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems.
跟踪增强了FDA命令强制召回的权力，并要求卫生专业人员和患者通知与设备相关的严重伤害风险。
Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a quality assurance program including audit procedures. Final distributors of these devices will be required to provide manufacturers with patient information.
Device tracking is required for the useful life of the device.
Thetypes of Medical devices按照跟踪顺序约束可能包括任何II类或III类设备：
- the failure of which would be reasonably likely to have serious adverse health consequences;
- 旨在将其植入人体超过一年；或者
- which is intended to be a life sustaining or life supporting device used outside a device user facility.
Patients who received a trackedmedical device可能拒绝释放或拒绝释放其姓名，地址，社会保险号或其他识别信息，以进行跟踪。