關於 predicate device中文 ，我們在網路上蒐集到這些相關的討論、資訊與評價

#11. 510(k)審查程序 - 量測中心醫療器材驗證室 首頁

... ( US FDA)准予在美國上市之醫療器材(Predicate Device)完成實質等效(Substantial Equivalence)評估，準備上市前通知申請文件(Premarket Notification Submission)。

#12. 10 分鐘搞定美國FDA 510(k) 文件 - 超強法規筆記本

Section 1 – Medical Device User Fee Cover Sheet (Form FDA 3601) ... 放上Predicate 的基本資訊，例如Device Name、Manufacturer、510(k) Number。

#13. [美國]二級產品新豁免清單– 2020年9月 - Qualtech

Based on the US policy, any medical device in introduction or delivery ... with predicate devices, a 510k would still be required to submit.

#14. 510(k) Premarket Notification - Accessdata.fda.gov - US Food ...

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, ...

#15. What is a 510(k)? - Emergo

The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US) ...

#16. 非主動式醫療器材共通性安全性試驗摘要資訊表

Affidavit of Pre-clinical Testing Conformity for Medical Device ... or the comparative data comparing the device with a predicate device must be provided).

#17. consultant service for medical device regulation ...

Many countries regulate medical devices and in vitro diagnostic devices. ... the device performs as safe and effectiveness as the predicate device.

#18. 無類似品醫療器材產品上市之研究__臺灣博碩士論文知識加值系統

論文名稱(外文):, A study of market approval for medical device with no predicate device. 指導教授: 洪光宗 ... 語文別: 中文. 論文頁數: 53.

#19. Medical Devices and 510(k) - SGR Law - Smith, Gambrell ...

The applicant must show substantial equivalence to a predicate device by way of a premarket notification, known as a “510(k),” at least 90 days before ...

#20. 跨領域科技管理與智財運用國際人才培訓計畫104年海外培訓

項目, 中文名稱, 重點介紹 ... A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; ...

#21. predicate | translate to Traditional Chinese

predicate translate: 謂語, 斷言，斷定，肯定. Learn more in the Cambridge English-Chinese traditional Dictionary.

#22. FDA 510(k) 簡介 | 蘋果健康咬一口

所以510(k)的資料是顯示比對性的資料，即新器材與predicate device的實質相等性。 綜合以上內容可知，絕大部分產品在完成企業註冊、產品列名和GMP品質系統， ...

#23. 510(k)檔案是向FDA遞交的上市前申請檔案 - 中文百科知識

—與predicate device有相同的使用目的，具有不同的技術性能，但是並沒有增加安全性和有效性的問題，並且證明人證明器械與合法上市器械一樣安全有效。

#24. WAFRegional::Rule Predicate - AWS CloudFormation

Predicate resource for WAFRegional. ... 中文(繁體) ... A unique identifier for a predicate in a Rule , such as ByteMatchSetId or IPSetId .

#25. 醫療器材Q&A（51）

Predicate Device (s) ... Special 510(k): device modification and design controls ... 貼表上之中文仿單目. 錄、使用說明書、包.

#26. FDA 510K 服务 - 深圳医疗器械FDAUDI食品FDA化妆品 ...

申请者必须提交描述性的数据，必要的时候，要提交性能数据来说明器械是predicate device的等价器械。再次说明，510(k)的数据是显示相似性的数据，即，新器械 ...

#27. FDA approval and regulation of medical devices: a primer

Clarivate Analytics has added medical device considerations to our coverage ... the device substantially equivalent to a predicate device.

#28. 進階模式的情境感知存取權範例 - Google Support

device.certificates.exists(cert, predicate). 在本範例中，cert 是簡單的ID，可用於述詞變數中，藉此繫結至裝置企業憑證。exists() 巨集會結合每個元素的述詞結果 ...

#29. 衛生福利部函

產品中文名稱 ... the comparative data comparing the device with a predicate device must be ... with a predicate device are attached in case of review.

#30. Predicate 释义| 柯林斯英语词典

Predicate 释义: In some systems of grammar , the predicate of a clause is the part of it that is not the... | 意思、发音、翻译及示例.

#31. De Novo - 海河生物医疗集团

De Novo Submission, OUR SERVICE. The de novo process provides a pathway to classify a low to moderate risk device for which general controls or general and ...

#32. Article Content - Laws & Regulations Database of The ...

Registration for a medical device with new mechanism, new structure, new material, new function, or with no similar predicate: TWD 65,000. (II). Registration ...

#33. 美國FDA

FDA/CE/CFDA/ISO/GMP/QSD/QSR/TFDA Consulting for Medical Device ... 醫材公司向美國FDA申請醫療器械(Medical Device)和已合法上市銷售的醫療器械(Predicate Device) ...

#34. Medical Devices Act and Regulations Governing Issuance of ...

(2)For Class 2 medical devices with predicate device(s) that have been approved for marketing ... 產品中文名稱Product Name (Chinese).

#35. medical device 中文 - Slobo

意志， “chinese journal of medical device” 中文翻譯： 醫療裝備. ... 當走US FDA 510(k)途徑時，只要實質比對的predicate device並無進行人體臨床，而自家的產品 ...

#36. Predicate Device的简体中文翻译 - 自动识别翻译

Predicate Device. Predicate Device. 16/5000. 自动识别, 世界语, 丹麦语, 乌克兰语, 乌兹别克语, 乌尔都语, 亚美尼亚语, 伊博语, 俄语, 保加利亚语, 信德语, 修纳语 ...

#37. 東南亞國協醫療器材法規實務經驗分享

2017.07.29. Medical device registration in emerging markets ... 黏貼或裝釘於標籤黏貼表上之中文仿單目錄、使用說明書、包裝及標籤各三份.

#38. Predicate Device - 什么意思？ 中文翻译英文

Predicate Device. 5个回答. 谓词设备 2013-05-23 12:21:38 回答:匿名. 谓词设备 2013-05-23 12:23:18 回答:匿名. 谓语设备 2013-05-23 12:24:58 回答:匿名. 谓词设备

#39. 衛生福利部食品藥物管理署「106 年度委託科技計畫 - 國立成功 ...

中文 摘要. 隨著積層製造（3D 列印）機台、醫學影像與各式電腦輔助繪圖技術的發展， 使得. 3D 列印技術日漸廣泛應用於各種領域 ... to the predicate devices. K133809.

#40. CDSCO published the list of 21277 Approved Devices - LinkedIn

How can you establish Substantial Equivalence (SE) with a predicate device? Identify the approved device in India which similar to your device.

#41. predicate device - 中国的翻译

Predicate device 的中国的翻译– 英语-中文字典和搜索引擎, 中国的翻译. ... Device. 设备. terrorism is recognized as a predicate criminal offence.

#42. Predicate | Android Developers

Public methods · test · More Android · Discover · Android Devices · Releases · Documentation and Downloads · Support.

#43. China implements New Fundamental Medical Device ... - Qserve

China implements New Fundamental Medical Device Regulations Order No. ... and clinical data from predicate device and reference device(s), ...

#44. device中文意思

predicate device 的中文翻译，predicate device是什么意思，怎么用汉语翻译predicate device，predicate device的中文意思，predicate device的中文，predicate device ...

#45. predicate device 中文意思是什麼 - TerryL

predicate device 中文 意思是什麼 · predicate: n 1 【語法】謂語，述語。2 【邏輯學】謂項，述項，述詞，賓詞。3 本質；屬性。adj 謂語的，述語的；謂... · device: n. 1.

#46. Balancing innovation and medical device regulation: the case ...

Keywords: medical devices, regulation, safety and effectiveness, ... To qualify as a predicate, the device should have the same intended use ...

#47. 變形骨頭重新長回來! DePuy推出3D個人化軟體輔助骨骼醫材

在該文件中所指涉的predicate devices為自家產品Synthes Distraction Osteogenesis (DO) System，和Smith & Nephew的TSF。

#48. Modernizing the FDA's 510(k) Review Process - MasterControl

December 19, 2018 By Alex Butler, Manager of Medical Device Solutions, ... Our device, which was superior to the predicate, received an FDA clearance.

#49. Bringing a New Genetic Test Directly to Consumers (Part 2)

Establish your predicate. The predicate device needs to be similar in intended use (i.e.: labeling) and in technology to your genetic test, ...

#50. Regulatory Affairs › USA - PROSYSTEM

The Food and Drug Administration demands from all medical device manufacturers ... equivalent to already legally marketed predicate devices in the US.

#51. Median Technologies is moving forward with the FDA ...

... Lung Cancer Screening CADe/CADx Software as Medical Device ... on reviewing pivotal study protocols and possible predicate devices.

#52. Medical device registration in US

Technically, the FDA does not "approve" medical devices or IVDs for sale under the ... An identification of the predicate device, to which substantial ...

#53. NMPA Announcement on Implementing Relevant Matters of ...

As of June 1, 2021, the enterprises and the medical device R&D institutions, ... literatures and clinical data of predicate medical devices; ...

#54. ASM Medical Materials Database – Ansys Granta

Enjoy immediate access to critical materials information, including from previously approved (i.e., 'predicate') devices; Screen, analyze, select and source ...

#55. Safe and effective digital dentistry products on the US market

Regulations to ensure safety and effectiveness of medical devices ... Since we can now use the Abutment Blank as our predicate device in the ...

#56. Sen. Markey Applauds CDRH Database Improvements

The Democratic senator from Massachusetts, highly critical of the potential for a device to be FDA-cleared with a predicate that has been ...

#57. Maze of US regulations cover medical devices from ...

Not all devices have a similar product that has been cleared or approved by the FDA. Class II devices that do not have a predicate device go ...

#58. 如何准备510（K）申请文件？ - 医疗器械 - 美国FDA注册

FDA中文站，口罩FDA注册，眼镜FDA注册，美国FDA注册， ... 申请上市器械的名称型号和分类资料、进行实质等效比较的产品（Predicate Device）名称及其510（K）号码；

#59. Values in a Predicate Expression - Salesforce Help

Developer Edition; Enterprise Edition; Essentials Edition; Professional Edition; Unlimited Edition. Experience. Salesforce Classic; Mobile

#60. predicate upon 中文意思是什麼 - Dict.site 線上英文字典

目前還沒有predicate upon例句。 相似字; 英漢推薦; 漢英推薦. predicate device · predicate symbol.

#61. 中國醫藥大學暨亞洲大學 『生醫轉譯加值人才培育-Anchor ...

中文. 英文. 研發現況. 提案分類：☐醫 藥 ☐醫 材 ☐其他： ... New technology employed or the technology is fundamentally similar to a predicate device

#62. Handle errors with custom predicate | Workflows | Google Cloud

Defines a custom error handler, including a custom predicate and custom backoff parameters. Explore further. For detailed documentation that includes this code ...

#63. ‧ 國立政治大學‧

選作比較基準的比對器材（predicate device）， ... 19 由於台灣及美國的說明文字一致，僅有英文及中文語言上的差異，因此僅放置台灣的說明文字，而 ...

#64. Predicate Device - Deutsch Übersetzung - Englisch Beispiele

Übersetzung im Kontext von „Predicate Device“ in Englisch-Deutsch von Reverso Context: Xpect & Predicate Device vs. Microscopy.

#65. 公告「紅外線耳溫槍」等8 項為醫療器材許可證核發與登錄及 ...

Medical device License. Number. 產品中文名稱 ... comparative data comparing the device with a predicate device must be provided).

#66. China Unveils New Medical Device Regulations - Ropes ...

The Chinese State Council has passed new Medical Device ... data or analysis of clinical literature and clinical data on predicate devices.

#67. USA FDA - Landlink Healthcare

These are referred to as predicate devices. We provide a product-specific list of documents and information needed for the 510(k) submission. An assigned U.S. ...

#68. Medical Device Submissions Workshops - AdvaMed

Join us in 2022 for our three online medical device submissions workshops, including: 510(k) and De Novo Submissions, IDE Submissions and PMA Submissions.

#69. predicate - Traduction anglais-français - Dictionnaire PONS

Here you can find our legal notice. We and our partners process data to provide: Use precise geolocation data. Actively scan device characteristics for ...

#70. [ EU MDR 深入探討: CER, PMCF 和PMS 為何物? (上) ]

US FDA與EU Medical Device Regulation (MDR) 對於Class II醫療器材管控 ... 當走US FDA 510(k)途徑時，只要實質比對的predicate device並無進行人體 ...

#71. The "predicate facts" rule: Providers, be vigilant! - Dentons

Medicare GME payments do not compensate teaching hospitals for their actual costs of training residents in a given year.

#72. Query Builder Predicate Reference - Adobe Experience League

This is a filtering-only predicate and cannot leverage a search index. Properties. property1. path to first date property. property2. path to ...

#73. Complete Design Development and Manufacturing Services ...

Aran Biomedical offers a complete solution to medical device ... of the commercial opportunity, predicate devices already on the market, ...

#74. 13.01.500 Prescription Digital Therapeutics - Premera Blue ...

received FDA 510(k) marketing clearance (K162532) as substantially equivalent to a marketed predicate device DiabetesManager®Rx (the initial and.

#75. capstone-影像處理中的數學

Segmentation: 以預定logical predicate Q, 將R分為數個不相交連通集之連集: Ri, i = 1, ... 如autonomous navigation(自主導航); stereo machine vision algorithms; ...

#76. Schoelly :: Registration - Canada and the USA - Schölly ...

For these products, a Device Listing is sufficient. ... the own product to a competitive product must be shown (the so-called predicate device) and a great ...

#77. 瞭解AZURE IOT 中樞AMQP 支援 - Microsoft Docs

IoT 中樞主機名稱, <iot-hub-name>.azure-devices.net ... to set the filtering predicate on the source URI def set_endpoint_filter(uri, ...

#78. FDA Permits Marketing of First SARS-CoV-2 Diagnostic ... - ICH GCP

... the FDA has also revoked the EUA for this device, which was initially ... clearance by demonstrating substantial equivalence to a predicate device.

#79. 淺談美國醫療器材管理方式@ MD's Blogger

依據醫療器材使用者付費與現代化法(Medical Device User Fee and Modernization Act of 2002, MDUFMA)，U.S. FDA可向醫療器材業者收取案件申請費， ...

#80. Predicate Device | Greenlight Guru

A predicate device is a medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval ...

#81. AutoCAD 2023 for Mac Developer and ObjectARX Help | List ...

Checks whether the predicate is true for every element combination. (vl-list* object [more-objects ...]) Constructs and returns a list.

#82. 5.01.35 Prescription Digital Therapeutics for Substance Use Disorder

The predicate device was reSET®. References. 1. McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders.

#83. First Patient Treated With LC Bead LUMI™ Radiopaque Embolic ...

... for clinical use in the US in December 2015 after extensive laboratory testing based on the clinical foundation of its predicate device, LC Bead®.

#84. 21 CFR Part 807 Subpart E -- Premarket Notification Procedures

(3) The predicate device has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be ...

#85. FFT Algorithm Based Audio Spectrum Analyzer. - podologie ...

Predicate Nominatives and Nominative Case. MPC-HC, the free, ... It a global agreement on how our devices render the symbols for all languages, …

#86. pywinauto find elements. print Elements with this window ...

@FunctionalInterface public interface Predicate. This file contains bidirectional Unicode text that may be ... 5 Real-Time Use Cases using Machine …

#87. kpsm

Stingers Up! Robert S. Our technology leverages machine learning and … ... 全球领先的中文搜索引擎、致力于让网民更便捷地获取信息，找到所求。

#88. Medical Device De Novo Classification Process - Federal ...

Section 513(f)(2) of the FD&C Act provides that any device classified through the De Novo pathway “shall be a predicate device for determining ...

#89. 醫療器材法規小學堂- 有一段時間沒有分享美國法規 ... - Facebook

你可能已經知道在做510k送審時，需要找到一個predicate來證明實質相等性， ... 這時候，我們會叫這個被引用的產品reference device (而不是predicate).

#90. Substantial Equivalence in a Predicate Device - YouTube

Substantial Equivalence is a unique concept to 510(k) Submissions to the FDA. This type of regulatory submission differs widely from CE ...