2022年7月25日,FDA官网又更新了:《Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices》 FDA再次更新该指南文件,足见FDA在美国推行唯一医疗器械标识码(UDI)的重视...
including both intrusive methods (e.g., dot pin; etching; direct laser marking; etc.) and non-intrusive methods (e.g., cast/forge/mold; laser bonding; stencil; permanent adhesive label; etc.
5. What will my UDI label and direct part marking look like? Below are examples of: Sensor box labels with previous version and updated UDI labels Sensor with direct part marking Cable with direct part marking Please Note: Depending on type of product, the label will contain one of two dat...
FDA Releases New Guidance on UDI Direct Marking RequirementsLina R. KontosJodi Scott
Under 21 CFR 801.45, "[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use." FDA draft guidan...
prosthesis UDI Class 1 UDI Class 111 DPM Class 1 UDI Class 11 DPM Class 111 UDI Class 1 DPM Class 11 2019 2020 2021 2022 2023 2013 2025 2027 2026 Registration EUDA MED Regulation in force 2018 DPM Class 11 UDI –Unique Device Identification DPM –Direct Parts Marking UDI Class 4 UDI Cl...
LS/LS = life-supporting or life-sustaining I/LS/LS = Implantable, life-supporting or life-sustaining Direct Mark requirements apply to products that are intended to be used more than once and intended to be reprocessed before each use. Direct mark compliance dates are in addition to label/GUD...
(a) any type of direct marking would interfere with the safety or performance of the device; (a) 任何类型的直接标记都会干扰器械的安全或性能; (b) the device cannot be directly marked because it is not technologically feasible. (b) 由于技术上不可行,无法直接对器械进行标识。
The 'labelled' UDI (on the actual device) meets both the UDI label requirement as well as the DM requirement. It is also important to draw a distinction between DM and Direct Part Marking (DPM). DPM generally refers to an invasive (e.g. laser etching) technology used to 'engrave' a ...
5. What will my UDI label and direct part marking look like? Below are examples of: Sensor box labels with previous version and updated UDI labels Sensor with direct part marking Cable with direct part marking Please Note: Depending on type of product, the label will contain one of two dat...