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

#11. Intended purpose – The European ... - EU MDR

Defining the intended purpose of the future planned device is the starting point for all decisions, including whether the product is a medical device or not ...

#12. A Question of Intent: FDA Amends Intended Use Regulations ...

The concept of intended use is a cornerstone of FDA's regulatory scheme that determines whether and how the Agency regulates a product as a ...

#13. FDA clarifies evidence and knowledge requirements in ...

FDA clarifies evidence and knowledge requirements in intended use final rule ... On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) ...

#14. Intended use definition and meaning | Collins English Dictionary

Intended use definition: If you intend to do something, you have decided or planned to do it. [...] | Meaning, pronunciation, translations and examples.

#15. The intended purpose – or, what does your medical device do?

The intended purpose describes the intended medical use—not the specific product features or specifications of an anticipated product—and has to ...

#16. Writing An Intended Use for Software as a Medical Device

The Intended Use is the most important document, ever, if you want to certify your software as a medical device. Why?

#17. MDCG 2021-24 Guidance on classification of medical devices

Normally intended for continuous use for more than 30 days. Page 8. Medical Devices. Medical Device Coordination Group Document. MDCG 2021 ...

#18. FDA finalizes long-awaited intended use rule - Regulatory ...

The only change from the proposed rule is a modification to the codified language of the intended uses regulation, “to clarify its ...

#19. FDA issues final rule clarifying its “intended use” regulations ...

The intended-use doctrine states that manufacturers must develop products that are reasonably safe for their intended use. FDA regulations ...

#20. Four Ways FDA's New Intended Use Regulations Affect Drug ...

“Intended use” determines whether a drug or medical device is misbranded or otherwise in violation of the Federal Food, Drug, and Cosmetic Act ( ...

#21. Intended purpose - 用途 - 國家教育研究院雙語詞彙

出處: 商標法. 以Intended purpose 進行詞彙精確檢索結果. 出處/學術領域, 英文詞彙, 中文 ...

#22. Intended Use | Office of Financial Management

Extending online government services to all citizens in Washington State. 1.2 Definitions. "Office of Financial Management website" shall mean the Internet ...

#23. FDA Finally Finalizes the Intended Use Rule - Stinson LLP

Last week, FDA published its new final rule amending the “intended use” regulations for drugs and medical devices, which it hopes will “put ...

#24. Compliance takeaways from FDA's final 'intended use' rule

The U.S. Food and Drug Administration's “intended use” final rule reaffirms the agency's wide latitude of discretion in establishing an ...

#25. Property, Plant and Equipment: Proceeds before Intended Use

In May 2020, the International Accounting Standards Board (Board) issued Property, Plant and Equipment—Proceeds before Intended Use, which made amendments ...

#26. Water Rights | California State Water Quality Control Board

Home · drinking water · services · funding; DWSRFIUP. heading. DWSRF Intended Use Plan (IUP). heading. 2021-2022 Intended Use Plan ...

#27. Intended Use Definition: 291 Samples | Law Insider

Define Intended Use. means the use of machinery in accordance with the information provided in the instructions for use;

#28. IAS 16 Amendments - Proceeds before Intended Use - EFRAG

​On 20 June 2017, the IASB issued the Exposure Draft ED/2017/4 Property, Plant and Equipment - Proceeds before Intended Use (Proposed amendments to IAS 16) ...

#29. Intended Use Plan : Clean Water State Revolving Fund

DEQ is required to submit to EPA an Intended Use Plan as part of the ... the CWSRF loan program intends to use funds available each year.

#30. 2021 Final SRF Intended Use Plans | Mass.gov

MassDEP's Final 2021 Intended Use Plans detail projects that will be financed through the Clean Water & Drinking Water State Revolving Fund programs.

#31. Compliance with intended use of Bar Code Medication ...

... the efficiency of use. Hospitals implementing bar coding should facilitate the intended use through equipment procurement, implementation, and quality …

#32. FDA Issues Final Rule Modifying The Intended Use Regulation

A determination of “intended use” is fundamental to FDA's regulation of drugs and medical devices. It is a primary basis for determining if ...

#33. Intended Use Plans

Each year the CWSRF and DWSRF publish an Intended Use Plan (IUP), which explains how the SRF funding capitalization grant provided by the Federal government ...

#34. Intended Use Plans | Georgia Environmental Finance Authority

An Intended Use Plan (IUP) accompanies the Georgia Environmental Finance Authority's (GEFA) annual applications to the U.S. Environmental Protection Agency ...

#35. intended use-翻译为中文-例句英语

使用Reverso Context: intended for use, intended to use, intended for the use，在英语-中文情境中翻译"intended use"

#36. Clean Water State Revolving Fund (CWSRF) Loan Program

What types of projects can I use the loan funding for? ... please see the CWSRF Intended Use Plan located on the upper right side of this webpage.

#37. Intended Use Plans (IUP)

Intended Use Plans (IUP). State Fiscal Year 2022. Alaska Clean Water Fund, Alaska Drinking Water Fund. Intended Use Plan (PDF) ...

#38. State Revolving Fund Intended Use Plan - PA DEP

State Revolving Fund Intended Use Plan. Notice. The Pennsylvania Infrastructure Investment Authority (PENNVEST) and the Department of Environmental ...

#39. FDA Intended Use

FDA Intended Use. Importing FDA-regulated products? As a customs broker, Livingston needs to know how the product being imported is intended to be used ...

#40. Begin Your Risk Analysis with Intended Use and Foreseeable ...

Risk analysis is a requirement of ISO 14971:2019. It needs to begin with a clear understanding of the intended use and foreseeable misuse.

#41. Revenue earned before an asset is ready for its intended use

... the cost of an item of property, plant and equipment (PP&E), any sales proceeds earned before the asset is ready for its intended use.

#42. ISO 13485:2016(en), Medical devices

a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use;. b) specifications for product;. c) ...

#43. Project lists and intended use plans | Wisconsin DNR

Find project priority lists (PPLs), intended use plans (IUPs), and funding lists by state fiscal year (SFY) for the Environmental Improvement Fund (EIF) ...

#44. IAS 16 — Proceeds before intended use - IAS Plus

Completed 2020. The IASB issued 'Property, Plant and Equipment — Proceeds before Intended Use (Amendments to IAS 16)' on 14 May 2020.

#45. Children's Products | CPSC.gov

A statement by the manufacturer about the intended use of the product, ... Certain general use products subject to mandatory consumer product safety rules ...

#46. Clean Water Revolving Fund 2022 Intended Use Plan - MN.gov

The Intended Use Plan (IUP) identifies projects on the PPL that are eligible to apply for and receive. CWRF loans in FY 2022. The IUP is ...

#47. 40 CFR § 35.3150 - Intended Use Plan (IUP). - Legal ...

§ 35.3150 Intended Use Plan (IUP). (a) Purpose. The State must prepare a plan identifying the intended uses of the funds in the SRF and describing how ...

#48. WQ eligibility survey and intended use plans - Colorado ...

When the survey is complete, your system's infrastructure needs will be identified and included in Appendix A Project Eligibility List of the below Intended Use ...

#49. Drinking Water State Revolving Fund Program Intended Use ...

Intended Use Plan for FY 2021. This Program is made possible with funding support from the: EPA-logo. Dear Waterworks Owner and Other Interested Parties: Under ...

#50. SRF Loan Fund, Maine Department of Environmental Protection

State Municipal Wastewater Grant Program and. Clean Water State Revolving Loan Fund. Current fiscal year information. Intended Use Plan.

#51. FSA Intended Use Codes

*--The following are the intended use codes and definitions. Code Intended Use. FSA-578. Printout. Definition. Co. Cover Only. Cover. Intended not ...

#52. FDA Issues Proposed Rule to Amend Intended Use Regulations

Evidence Relevant to a Product's Intended Uses. The prior rule issued by FDA in 2017 created significant confusion, in part due to its broad ...

#53. Intended Definition & Meaning - Merriam-Webster

The meaning of intended is expected to be such in the future. How to use intended in a sentence.

#54. FDA medical app regulation and the art of intended use

Paraphrasing a bit, FDA regulates any smart phone apps intended for use in the diagnosis or treatment of disease or other conditions. And that ...

#55. hazmat/high-piled combustible storage owner's statement of ...

OWNER'S STATEMENT OF INTENDED USE. The code provisions applicable to facilities with hazardous materials, high hazard and high-piled combustible storage.

#56. Intended Use Summary & Important Safety Information | Varian

Intended Use Summary for Linear Accelerators. Varian Medical Systems' linear accelerators are intended to provide stereotactic radiosurgery and precision ...

#57. Intended Use of Influenza Vaccines - BC Centre for Disease ...

Intended Use of Influenza Vaccines. The influenza biological product pages provide guidance on the use of influenza vaccines that are.

#58. What is the difference? An overview of “Intended for Use ...

“Intended Use” is defined as the general use statement of a medical product or “what is the use of the device?”1 It tells the user what the ...

#59. its intended use | English examples in context | Ludwig

High quality example sentences with “its intended use” in context from reliable sources - Ludwig is the linguistic search engine that helps you to write ...

#60. Accounting for proceeds before an asset's intended use

Highlights. Sale proceeds no longer deducted from the cost of property, plant and equipment (PPE) before its intended use; Testing the ...

#61. Recommended International Code of Practice - Food and ...

Food safety - assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.

#62. MM18 (E) – DECLARATION OF INTENTION TO USE THE MARK

MM18 (E) – DECLARATION OF INTENTION TO USE THE MARK –. UNITED STATES OF AMERICA. To be annexed to each international application or subsequent designation ...

#63. FDA's Regulations on “Intended Use”: One More Try

By: Daniel Dwyer On September 23, 2020, FDA published a proposed rule that would amend its medical product “intended use” regulations.

#64. Preparatory Stage F: Identify intended use of the product

Apologies for any inconveniences caused. Statement. The HACCP team need to have a thorough understanding of the intended use of the product(s) included in the ...

#65. Registering as a food importer - Ministry for Primary Industries

UPDATES · All food for sale must be imported by a registered food importer · Food importer registration · Make your intended use of food ...

#66. State Revolving Fund Resources and Documents - Florida ...

Part of this request is the submittal of an intended use plan (IUP) which details the operation of Florida's SRF programs and how the ...

#67. intended use (預期的用途)

intended use (預期的用途). 上圖是摘錄曾經處理的案子，主要是講到被核駁案中的權利範圍有個元件（或特徵）在引證案中並未揭露，但審查委員認為這個 ...

#68. Intended use of building | Concepts | Statistics Finland

The classification of the intended use of buildings is given in Statistics Finland's Handbook Classification of Buildings 2018. Not all the classes in the ...

#69. FDA clarifies "Intended Use" - ECA Academy

The U.S. FDA revised the text of their intended use regulation to provide additional examples and explanation. In particular clarity is ...

#70. Employment Affidavit of Intended Use - PennDOT

INSTRUCTIONS FOR COMPLETING THE AFFIDAVIT OF INTENDED USE. 1. The affidavit must be completed and signed by a member of your agency or firm who has the.

#71. Software as a Medical Device (SaMD): Key definitions

no restrictions on the reproduction or use of this document; however, incorporation of this ... Intended use / intended purpose .

#72. Clean Water State Revolving Fund Loan Program

2015, Intended Use Plan with Amendment · Project Priority List Amendment I · Project Priority List Amendment II · Appendices · Annual Report.

#73. 2111-Claim Interpretation; Broadest Reasonable ... - USPTO

During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the ...

#74. FDA Proposes Clarifying Intended Use Regulations - Policy ...

Earlier this year, the United States Food and Drug Administration (FDA) published a proposed rule that would amend its “intended use” regulations for ...

#75. ATALANTE Intended use - Wandercraft

The Atalante system is intended to perform ambulatory functions, mobility exercises and adapted physical exercises, hands-free, for individuals ...

#76. FDA proposes clarification on how it will determine the ...

The intended use of a product, as interpreted by FDA under the regulations in 21 C.F.R. §§ 801.4 (covering devices) and 201.128 (covering drugs) ...

#77. Finding the intended use population for a new treatment

Since the classifier C was developed using the full clinical trial dataset, the empirical treatment effect in this intended use subset of C will ...

#78. Appendix R - Intended Use Codes for ACE - US Customs and ...

This Appendix provides the intended use codes that may be used by trade when submitting data via the PGA Message Set.

#79. From RUO to IVD – the acronym guide to reagents' intended use

Even in posts. Today, we will have a look at some acronyms used in research, and how they relate to the intended use of reagents. Let's start ...

#80. Regulatory status of equipment being used to help prevent ...

Face coverings intended for use by the general public are not PPE or medical devices. As such they do not carry a CE / CE UKNI/UKCA mark and should not be sold ...

#81. Drinking Water State Revolving Fund (DWSRF)

To meet that requirement, the State prepares an annual Intended Use Plan (IUP), which provides information on types of financial assistance ...

#82. Intended Use VS Indications For Use - Advena Ltd

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages.

#83. Rapid reviews in health policy: a study of intended use in the ...

We examine what prompted policy makers to commission rapid reviews, their purpose, how and when they intended to use them, and how this varied by agency. Policy ...

#84. Functional Limitations vs. Intended Use - Element IP Law

Element IP's patent professionals' insights into the intellectual property law matters.Functional Limitations vs. Intended Use.

#85. Refocusing Medication Prior Authorization on Its Intended ...

First, focus prior authorization on its intended purpose. Health plans should eliminate prior authorization requirements for medications that ...

#86. Identifying the Intended User(s) and Use(s) of an Evaluation

The purpose ofthis guideline is to provide ideas and suggestions for identifying the primary intended user(s) and the intended use(s) ofan evaluation and ...

#87. Intended Use and Limitations - CellSearch

For in vitro diagnostic use. The CELLSEARCH ® Circulation Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin ( ...

#88. 21 CFR 201.128 - Meaning of “intended uses”. - Content Details

Subchapter C - DRUGS: GENERAL Part 201 - LABELING Subpart D - Exemptions From Adequate Directions for Use Section 201.128 - Meaning of “intended uses”.

#89. Disclosure of Intended Use of Proceeds and Underpricing in ...

ABSTRACT We use the context of a company's initial public offering (IPO) of equity securities as a capital-markets setting to empirically ...

#90. Accounting for proceeds before an ... - KPMG Advisory Services

Amendments to IAS 16 introduce new guidance on property, plant and equipment proceeds before an asset's intended use.

#91. Principle (b): Purpose limitation | ICO

What is the purpose limitation principle? · be clear from the outset why you are collecting personal data and what you intend to do with it; · comply with your ...

#92. The Effect of Foregrounding Intended Use on Observers' Ratin...

The objective of this study was to explore the effect of foregrounding a different intended use (formative vs summative learner assessment) on observer ...

#93. Minimum Necessary Requirement | HHS.gov

... steps to limit the use or disclosure of, and requests for, protected health information to the minimum necessary to accomplish the intended purpose.

#94. Overview of medical devices and IVD regulation - Therapeutic ...

You should refer to this definition for any regulatory purpose, ... IVD medical devices can also be intended for use by a health ...

#95. Issue View | Council III | 2016 Biennial Meeting - Conference ...

“Intended Use” for Raw Beef Source Materials ... intact beef such as beef primal and subprimal cuts and identify their "intended use" for further preparing ...

#96. Intended Use - Performance Validation

Let PV's CSV professionals help you identify the intended use of your software and develop a cost-effective compliant validation approach.