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UDI Exceptions | 全台第三方支付網

UDI Exceptions

Inordertoestablishasystemtoadequatelyidentifymedicaldevicesthroughdistributionanduse,theFDAexpectsthatthelabelsofalmostalldevicesarecapable ...

 UDI Exceptions

The UDI rule provides a method for labelers to request exceptions and alternatives to UDI requirements.

On this page: Exceptions and Alternatives Granted by the FDA

Under to 21 CFR 801.55(c), any labeler may make use of an exception or alternative granted under § 801.55[1], provided that such use satisfies all safeguards or conditions that are part of the FDA exception or alternative decision.

Labelers should refer to the information in the table below, especially in the "FDA Decision" column, to determine if an exception or alternative listed may apply to their situation. Labelers may document the applicability and use of an exception/alternative in the device master record (DMR)[2] as part of the labeling specifications required under 21 CFR 820.181(d) for each respective device, along with a cop...

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Unique Device Identification System (UDI System) | 全台第三方支付網
2021年5月20日 — The FDA established the unique device identification system to adequately identify medical devices sold in the United States from ... Read More
UDI Basics | 全台第三方支付網
2019年5月14日 — Understanding the UDI Format ... A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following ... Read More
Unique Device Identification System | 全台第三方支付網
4 天前 — This document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling ... Read More
Global Unique Device Identification Database (GUDID) | 全台第三方支付網
2019年8月28日 — GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database. Read More
UDI Rule and Guidances, Training, Resources | 全台第三方支付網
Comprehensive list of links to the UDI rule and guidances, training for industry, UDI and GUDID technical resources, and dockets. Read More
UDI Exceptions | 全台第三方支付網
In order to establish a system to adequately identify medical devices through distribution and use, the FDA expects that the labels of almost all devices are capable ... Read More
Compliance Dates for UDI Requirements | 全台第三方支付網
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if​ ... Read More
US FDA UDI | 全台第三方支付網
US FDA UDI. 根據美國食品和藥物管理局（FDA）UDI法規規定（Unique Device Identification System Final Rule)，醫療器材製造商需在產品上標示醫療器材單一 ... Read More
美國FDA於2017年11月發表「醫療器材單一識別系統(Unique ... | 全台第三方支付網
如欲了解UDI 系. 統之核心概念，請參考「Unique Device Identification System Final Rule」。 2. 根據美國FDA 於2013 年9 月發佈《醫療器材單一識別系統法案》​， ... Read More
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