Intended use versus intended purpose
WebThe benefits of this rule are additional clarity and certainty for manufacturers and stakeholders regarding evidence that is relevant in evaluating whether an article is intended for use as a drug ... WebDec 9, 2024 · The FDA defines intended use as, “the objective of the persons legally responsible for the labeling of devices”. Put in simpler terms, the intended use is what the …
Intended use versus intended purpose
Did you know?
WebExamples of intended purpose in a sentence, how to use it. 18 examples: The intended purpose is to capture in an implementation-language independent way, the key concepts… WebWe should distinguish it from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an …
WebOct 19, 2024 · In the “intended use” regulations, FDA defines the term and describes the evidentiary basis for determining the intended use of articles that are being marketed. There is one regulation for devices and another for drugs, but they are in substance the same (21 C.F.R. §§ 201.128, 801.4 ). WebSample 1. Intended Purpose. Goods will be quoted and supplied according to the information and specifications provided by the Purchaser. It is the sole responsibility of …
WebApr 27, 2024 · “Intended purpose” is defined in Article 1 paragraph 2(g), as follows “(g) ‘intended purpose’ means the use for which the device is intended according to the data …
WebIntended purpose is defined in Article 2 (12): “ ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the …
WebIf you said that 𝗜𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝗨𝘀𝗲 refers to the core objective at the basis of the FDA regulations, then you get a gold star. Intended use is the intent (or purpose) for your device that can be shown via … top shelf hockey bemidjiWebFeb 5, 2024 · Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts: ISO 13485:2016 - Medical Device Quality Management Systems: 9: Aug 5, 2009: G: New intended use - Validation of a class IIb implantable (non-active) ISO 13485:2016 - Medical Device Quality Management Systems: 5: Aug 18, 2008: Intended Applicability of the … top shelf hockey bozemanWebIntended Use means a building product and the use thereof, for which the building product is intended to be, or is reasonably likely to be, associated with a building. Sample 1 Sample … top shelf hockey 21WebApr 27, 2024 · “ (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or... top shelf herbs of alaskaWebpurpose should be clearly expressed in the intended purpose statement, reflected in the instructions for use (IFU), and should include the specific elements outlined in Annex I, 20.4.1 (c.): (i) what is detected and/or measured; (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, top shelf hockey meaningWebSep 18, 2009 · Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts: ISO 13485:2016 - Medical Device Quality Management Systems: 9: Aug 5, 2009: B: 62368-1 Annex V1.6: "Terminals intended to be used by an ordinary person" CE Marking (Conformité Européene) / CB Scheme: 4: Feb 5, 2024: F: Multiple Intended Use … top shelf hockey nhWebThe intended purpose is usually a short statement of two or three sentences that focuses on what the device is intended to be used for. It is a required item in the Technical … top shelf hockey halifax