Identifying the intended audience can help with: The tone is a writer's attitude toward their subject and intended audience. What are some examples of a group audience? Specific Intended Audience: American high schoolers who have read The Bell Jar and know it very well. Hence indication of use also affects the classification of the medical device. But there are some surprises. Related to INTENDED USE OF THE PROPERTY. While a teacher might be your actual audience, it helps to imagine an 'intended audience' when writing. You identified your intended audience. Introduction and Summary B. Provided as a service to licensed and registered Illinois appraisal professionals as well as Illinois course providers and users of appraisals. We all understand that. Consider your purpose when imagining an intended audience. Reproductions are intended for use in publishing, exhibits, broadcasting, presentations, or design, or for similar purposes. Set individual study goals and earn points reaching them. These words are often used together. What does my audience already know about this topic? You are persuading your classmates to vote for you as class president. Replies to my comments Estoppel Statement (a) After request by Lender, Borrower shall within ten (10) days . Intended Medical Indication Describe the condition (s) and/or disease (s) to be screened, monitored, treated, diagnosed, or prevented by your software. Have all your study materials in one place. Rather, define exactly what it is in as few words as possible. Let's look at the different ways the intended audience can help you write your essay. Last modified July 8, 2021. Identifying your intended audience can help you decide on your purpose for writing. Again fees vary by type of land, intended use and area. The Purchaser acknowledges that the milk supplied under this Agreement is not intended for retail sale without further processing and is sold in bulk by the Supplier for further processing. Illinois Appraiser Newsletters promote a greater understanding of USPAP, the Act, and the Administrative Rules of the State of Illinois.promote a greater understanding of USPAP, the Act, and the Administrative Rules of the State of Illinois. Usage explanations of natural written and spoken English, The degree of formality required depends a great deal upon the, Explanation gives answer to why a component is necessary to realize the, A possible distinction could be drawn, however, between the, What matters is whether the repository of knowledge that you are constructing serves your, Many genetic services have effects beyond their, It is used to describe the management of a tree of ambients whose, Given the book's price, one can only assume that this is its primary, In their case, the campaign is not likely to serve the, However, historically, neither the importance of the trust lands', Any assessment of the measure's reliability should therefore be made relative to this, Such studies are expensive and time-consuming, but are necessary to evaluate the usefulness of the test method for its, Proficient learners identified more frequently the speaker's. The purpose of an essay is the effect the writer wants to have on the reader. FDA published a final rule, which goes into effect the first of September, to amend its "intended use" regulations. 18 examples: The intended purpose is to capture in an implementation-language independent How do you identify the intended audience? For example, you don't want to sound angry when trying to persuade your school principal to extend the lunch period. Updated October 20, 2022 Writing An Intended Use for Software as a Medical Device Dr. Oliver Eidel The Intended Use is the most important document, ever, if you want to certify your software as a medical device. Don't subscribe Depending on the intended use of the end device, different standards apply. You could use examples of how you have been a leader in the past. How is my audience similar to me? We believe that by revising the text of our intended use regulations to better reflect our longstanding practice, and by providing additional examples and explanation in the preamble, we will give clarity to stakeholders and enhance consistency in our regulatory approach. If your intended audience is a group of citizens living in your city, you would not need that background information. Intended audiences can be individuals, groups of people, or the general public. Put in simpler terms, the intended use is what the purpose of your device is. We value robust & civil discourse. The appraisal profession is probably the most regulated area in lending, Sure, why not. What tone would my audience respond to? Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not be using your device. When writing, do you ever think about who you are writing for? del dispositivo, estndares diferentes se aplican. Elements of a intended use Address the following aspects in your intended use: Medical indication (for example, illness) Intended patient group For example, every hour, I only have seven chances to win coins. Whether real or imaginary, the intended audience is who you should always think about when writing. 209 98 It was intended to encourage her, but it was more a distraction. Sample 1 Sample 2 Sample 3 (Definition of intended and purpose Your purpose might be to explain your analysis of the novel's setting to an audience that is familiar with it. One can look to the essay promptfor clues to identify the Intended Audience. Parents, teachers, school leaders, friends, peers, coworkers, American teachers, high school students, members of Congress, parents of children with disabilities, comic book fans, New Yorkers, Everybody, anyone, people on the internet. Each intended use requires an appropriate definition and the investigation of the . Create flashcards in notes completely automatically. First, Create an IUV Plan. Intended Use: According to ISO 14971, the intended use is defined as the "use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer". Such clarity and consistency are critical to ensuring that parties understand their regulatory obligations and that the FDA can exercise effective oversight responsibility. It is important to identify the intended audience so one can achieve their purpose for writing. When writing for a group audience, what should one consider? For instance, you might write an essay persuading your school principal to extend the lunch period. They are the specific people, in a specific position, in a specific organization who will use the evaluation findings and who have the capacity to effect change (for example, change policies and procedures, improve management strategies). Presentation means a lot. If the poster gets you upset, it is the Internet, you can walk away from it. But what if your intended audience is a group of people who have read The Great Gatsby? in the thong is important to think about. Or your purpose might be to explain how something works. Identifying the intended audience can help with establishing your purpose, choosing the right words, taking the right tone, selecting important information, and using effective examples and comparisons. Please keep remarks about the topic at hand, & PLEASE avoid personal attacks. For instance, when writing an analysis of The Bell Jar, people who have read the novel would be the intended audience. intended use. A products intended use determines whether it is a medical product within the scope of FDAs jurisdiction. The goal is to raise much needed awareness and support to change the broken AMC model within our industry. Here's what's included: SpanishDict is the world's most popular Spanish-English dictionary, translation, and learning website. Use of the Leased Property (a) Lessee covenants that it will proceed with all due diligence and will exercise reasonable efforts to obtain and to maintain all Licenses and other approvals needed to use and operate the Leased Property and the Hotel under applicable local, state and . When writing, use ONLY ______, ______, or _____ the intended audience is familiar with. Novotny, a general personal property appraiser in Los Angeles is frequently contacted to perform many types of appraisal intended uses, often for complete residential contents. See details of proposed use below (e.g., publication title, publisher 's name & address, publication run and format; location & dates of exhibit; design firm name & address; client name & address. Cambridge University Press), Moreover, consequently and therefore: ways to link ideas (2), 0 && stateHdr.searchDesk ? From USPAP: INTENDED USE : the use or uses of an appraiser's reported appraisal, appraisal review, or appraisal consulting assignment opinions and conclusions, as identified by the appraiser based on communication with the client at the time of the assignment. Don't focus on what it COULD be used for. New. Examples have not been reviewed. Cul es el sensor de radar correcto para mi, Over the centuries, changed several times its, Largo de los siglos, cambi varias veces su, Condiciones particulares aplicables segn el. You are describing the history of mass transit in your city. But what age are they? The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The agency considered the feedback and support we received on the proposed rule and made additional changes when we published the 2017 final rule. 159 82 I had made a promise to her and I intended to keep it, regardless of the outcome. We received many useful comments that assisted in our policy development. The purpose of an essay is the effect you want your writing to have on the reader. Knowing who you are writing for is key to deciding what attitude to take in your writing. An example of an Intended Audience is people who have read the text you are analyzing. The purpose of your essay determines what you will write. Examples of intended purpose in a sentence, how to use it. If the essay prompt gives no clues, what can be done to identify the intended audience? While writing the essay, ask yourself in-depth questions about the intended audience. There are many types of intended uses (Client objectives) discussed in detail below. If you were writing the Intended Use for your medical device, you would write something like this: Intended Audience Intended Audience 5 Paragraph Essay A Hook for an Essay APA Body Paragraph Context Essay Outline Evidence Harvard Hedging Language Used in Academic Writing MHRA Referencing MLA Opinion Opinion vs Fact Plagiarism Quotations Restate Summarize Summary Works Cited Argumentative Essay Emotional Arguments in Essays Sometimes this is a real person you know. You might mention the petition you started to add healthier options to the snack vending machines. Be as specific as possible about who they are. Which examples or comparisons would my audience understand? VA Adopts Uniform Appraisal Dataset (UAD), State Appraiser Coalitions & Organizations, Uniform Standards of Professional Appraisal Practice. It also gives the more detail on the part of the body where it is used which can also be part of the intended purpose. Desktop Appraisals: Has The Devil Infiltrated The Public Trust? When writing for a group audience, one should consider what this group of people is likely to know about and respond to in the essay. Appraisers Should Voluntarily Follow ANSI for Desktops? Indications of use = the conditions or reasons for using the device. Why Your Intended Use Is Important Why is that so important? The FDA defines intended use as, "the objective of the persons legally responsible for the labeling of devices". StudySmarter is commited to creating, free, high quality explainations, opening education to all. Related to Intended Use Statement. Will you pass the quiz? The proposed revisions to the intended use regulations do not reflect a change in the FDAs policies and practices, but rather seek to clarify the regulatory language describing the types of evidence we consider relevant to determining a products intended uses. Una vez ms, los honorarios varan segn el tipo de tierra, el destino y el rea. Be perfectly prepared on time with an individual plan. Definition English: Disorders that result from the, Definicin Espaol: Trastornos que resultan del, Ecuador explained that its definition was based on, El Ecuador explic que su definicin se basaba en la, Land would be specified with a sub-category to clarify its, Tierra sera dada un sub-categora para clarificar su, Many have met performance standards for its, Muchos han cumplido con los estndares de rendimiento para su, All items in the room must comply with their, Todos los elementos de la habitacin deben cumplir con su. An official website of the United States government, Commissioner of Food and Drugs - Food and Drug Administration, Recalls, Market Withdrawals and Safety Alerts, FDA Clarifies Types of Evidence Relevant to Determining the Intended Use of FDA-Regulated Products, Amendments to Regulations Regarding Intended Uses,. Your email address will not be published. Any opinions in the examples do not represent the opinion of the Cambridge Dictionary editors or of Cambridge University Press or its licensors. Here is what's meant by "intended audience.". When writing, it's important to consider your purpose. The design and composition of an article are examples of the types of evidence that may be relevant when determining the article's intended use. In the preamble to the proposed rule, we provide additional clarity by describing examples of types of evidence we would consider relevant to determining the intended use of a product, including a variety of direct and circumstantial evidence. Do not reproduce without permission of authors. If your intended audience is the general public, they may not be familiar with your city. For example, FDA may consider the design or composition of a product, which includes product characteristics, when determining whether the product is "intended to affect the structure or any Start . Everything you need for your studies in one place. These questions will guide you in your writing choices: An intended audience is the person or group of people a writer has in mind as potential readers for their work. Upload unlimited documents and save them online. All Where are they from? Dependiendo del uso del dispositivo, estndares diferentes se aplican. Identify your study strength and weaknesses. 1 - Consider what your intended audience already knows. You can also subscribe without commenting. If so, this is your intended audience. The intended audience for your analysis of The Bell Jar is people who have read the novel. (b) the basis for the classification of the future planned device into one of the four classes of device, as required by Article 47. What specifics are important to consider when identifying an intended audience? Una vez ms, los honorarios varan segn el tipo de tierra, el, In this case, customers would also have to decide according to the, Tambin en este caso el cliente tiene que elegir en funcin del, Evite el uso de este producto para cualquier otro propsito del que est. Preliminary Economic Analysis of Impacts A. Personal attacks harm the collegial atmosphere we encourage on AppraisersBlogs. Your purpose might be to persuade the reader to take action. The principal is your real audience. Public comment is an important part of the rulemaking process that can inform and influence the agency on critical regulatory matters. For example, it might state that you are writing a letter to a congressman or educating the general public on the history of your town. Free and expert-verified textbook solutions. Fig. Notify me of followup comments via e-mail. Then, write with the intended audience in mind! Take a moment to think about the purpose of your essay. We welcome critical posts & opposing points of view. In light of questions and concerns that arose from the changes made in the final rule, FDA decided to delay the effective date of the relevant portion of that 2017 final rule until further notice, to allow for additional consideration of the substantive issues raised in the public comments we received related to the final rule. 'pa pdd chac-sb tc-bd bw hbr-20 hbss lpt-25' : 'hdn'">. Who they are will depend on your . Why is it important to identify the Intended Audience? Formal? The intended audience also helps you establish the tone of your essay. What do they value least? Properly described, the intended purpose will provide; (a) confirmation, or not, of whether the product being considered fits the definition of an IVD device and therefore whether or not the regulation applies. of the users don't pass the Intended Audience quiz! Sample 1 Sample 2 Sample 3 See All ( 6) Intended Use. How in your opinion should this have better been handled or what would you do in this case? 972 113 He intended to take her as his mate, Rhyn. Copyright Curiosity Media, Inc., a division of IXL Learning. 'Intended Use' and the 510 (k) FDA wants you to be very "to the point" about your stated intended use on your 510 (k) submissions. Where can one look for clues to identify the intended audience? How to use Intended in a sentence intended Meanings Synonyms Sentences They were wrong, and she intended to prove it. It is important to know who you are writing to so you can achieve your purpose for writing. Have you tried it yet? For this reason, this rulemaking is an important priority for the FDA. Does it tell you who you are supposed to be writing for? Are valuations able to be copyrighted? Purpose Statement Upon request from a Lender or an Agent, the Borrower shall deliver to such Lender or Agent a completed Form U-l Purpose Statement or Form X-0 Xxxxxxx Xxxxxxxxx, as applicable, each as published by the FRB. Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the intended use of a product. Test your vocabulary with our fun image quizzes, Clear explanations of natural written and spoken English. Stop procrastinating with our study reminders. If your essay prompt does not specify an intended audience, come up with your own! This longstanding position remains unchanged in the regulations being proposed today. It is important to be as specific as possible when identifying the Intended Audience. Die IEC 60601-1:2013 defines the "usage in accordance to regulations" as operation, including routine inspection and adjustments through user, and standby correspondent to instruction manual. Save my name, email, and website in this browser for the next time I comment. Second, determine the intended use of the COTS software application. Examples of this include the conditions the device was designed to diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population. Let's say your Intended Audience is an imaginary group of people interested in reading The Great Gatsby. How are they different? Sign the Open Letter to AMCs. A second example, cited in Blue Book Memorandum #K86-3, relates to powered suction-aspiration devices, which were initially cleared to remove tissue and fluid from the body during surgery. All Rights Reserved. Are they real or imaginary? Identifying the intended audience can help you choose the right words when writing. There was only one intended user (owners representative) named on the reports. Earn points, unlock badges and level up while studying. You may openly disagree, but state your case in an atmosphere of mutual respect, in which everyone has a right to a particular view about the topic of conversation. In recent years, we have worked to revise certain language that is currently included in our intended use regulations and that does not accurately reflect current FDA policies. Coin Master is a simple game in which you spin the Slot Machine and collect coins to develop settlements. First, intended use is EXACTLY what your product is used for. To identify your intended audience, you need to establish your. What is an example of an Intended Audience? Appraisers Should Closely Watch Probe of Departed Brookings Boss. Sample 1 Sample 2 Sample 3 See All ( 5) Intended Use. Occupational Licensing Used to Intimidate, Lowballed It Is Open Season On Appraisers, Removing the Definition of Personal Inspection, Only Blacks Need Apply In the Spirit of Equity, Fannies Equity Plan: The Drinking Game, Property Data Reports for Appraisal Waivers. Look for these clues in your essay prompt. Required fields are marked *. FDA's longstanding position is that, in evaluating a product's intended use, any relevant source of evidence may be considered. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Intended Use means the construction, ownership, possession, use, operation, maintenance, and repair of the Project as contemplated under this Agreement without any increase in the cost of owning, possessing, using, operating, maintaining, or repairing the Project or the Project Site from and after the Closing. What if only your teacher will be reading your work? Or you might write an essay explaining cell phone history to high school students. Click on the links below to explore the meanings. In this case, high school students are an imaginary audience; you don't know exactly who they are. It states what your software does and in which context it is used. Why? The first step in identifying the intended audience is establishing the purpose of the essay. (user needs) Third, convert the user needs into requirements. To achieve the right balance of information in your essay, consider the intended audience. The preamble also outlines several examples of types of evidence that, standing alone, would not be determinative of intended use. Ain't there a law against lying? Your primary intended users are not all those who have a stake in the evaluation, nor are they a general audience. Fig. To identify your Intended Audience, you need to establish your purpose, consult the essay prompt and/or your imagination, decide what type of audience you are writing for, and get specific about who they are. Its 100% free. This proposed rule, Amendments to Regulations Regarding "Intended Uses," is an. The more you think about your intended audience, the stronger your writing will be! The guideline, based on Michael Quinn Patton's Utilization-focused evaluation, provides examples of facilitation questions that can be used to identify and involve users in the evaluation and a further set of questions that may be used to determine its use. What are the types of Intended Audiences? Educate them on an aspect of a text? Follow the steps below to decide who your intended audience is. Why is it important to identify the intended audience? True or False: The intended audience can be real or imaginary. Preliminary Economic Analysis of Impacts C. Initial Small Entity Analysis VIII. Flipping the 4th Grade ClassroomMath Instruction: Elapsed Time This proposed rule, Amendments to Regulations Regarding Intended Uses, is an important step forward in fulfilling our public health mission and our promise to provide better clarity to regulated industry and other stakeholders. Use the information from Steps 1-3 to determine what type of audience you are writing for. Preference Falsification Why Licensees Parrot Notions They Know Are Untrue, Visualizing Market Activity Using Graphs & Trendlines, Top DEI Bosses Have a Problem Diversity, UAD Composite Property Data Info Released to the Public, Maxine Waters Wants Appraisers Investigated, AMCs Take a Sizable Cut of the Appraisal Fee. Permission from the client was obtained directly and granted to share the data and workfile, although The intended use of the report was not for tax purposes but for negotiation and due diligence to make a purchase of the assets. Casual? In 2015, we issued a proposed rule that, among other things, would have revised that language. You can think of tone as the "voice" of an essay. intended use intend a meaning intend primarily intended purpose intended solely for intended use measures intended to merely intend no pun intended specifically intend Pronunciation Browse alphabetically intended use intended recipient intended solely for intended target intended use intended victim intendedly intendency Contraindications In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA's final rule on intended use, manufacturer's objective intent, and . A product's intended use determines whether it is a medical product within the scope of FDA's jurisdiction. Before sharing sensitive information, make sure you're on a federal government site. Think about age, location, interests, and familiarity with your subject. Think of the intended audience as the person or people you are writing for. There can be many intended uses for one appraisal. Which terms do I need to define for my audience? True or False: When writing for a General Public audience, it is safe to assume they are familiar with the subject. What does my audience value most about this subject? The audience's age, location, and level of expertise determine what kind of wording makes the most sense. Intended use = what you say on the label that the device is to be used for. These examples are from corpora and from sources on the web. Now it's time to use this knowledge to write your essay. If the essay prompt gives no clues, imagine who would be interested in the subject matter to determine the Intended Audience. You would need to include background information on the city. Let's explore these three types of intended audiences and look at some examples. You narrowed it down and got specific. 2 - Steps to identify your intended audience. Or. of the end device, different standards apply. Create the most beautiful study materials using our templates. Identifying an intended audience is important because it shapes what you write and how you write it. Your intended use can impact the regulatory pathway that you need to follow, so it is important to be accurate and clear when stating your intended use . The .gov means its official.Federal government websites often end in .gov or .mil. Do you want to persuade them? We generally include authors' info at the end of each article. We look forward to receiving input on todays proposed rule. Use of the Property The Tenant agrees with the Landlord as follows:-. The types of Intended Audience are: Individual, Group, and the General Public. Click on the arrows to change the translation direction. Sometimes it's a group of people you imagine would read your work. We believe these examples will help regulated parties to navigate common scenarios with greater certainty. Technical? '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 sales materials or statements and as specified by the manufacturer in the clinical evaluation; We believe that this update will provide greater certainty and predictability for regulated parties. Create beautiful notes faster than ever before. from the Cambridge English Dictionary Subsequently one year later apparently after the company made an acquisition of most of those assets, a tax accounting firm contacted my firm and told me they are auditing the workfile to form an irs basis for value. What does my audience still need to know about this topic? The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Think of tone as the "voice" of an essay. Write down some quick notes about them. After all, there are many different types of people who would be interested in what you have to say! You might narrow down your audience with these questions. Whether your intended audience is real or imaginary, they probably fall into one of these categories. They would likely already know it. You would use different words to explain something to a student than a member of Congress. Who would be interested in your essay's subject matter? Would this unintended use of the restricted appraisal report from an unintended user constitute a violation of USPAP and if so without the report being copyrighted is there any defense or recourse the appraiser can enforce? of.edu domains is for educational institutions. Your purpose would be to describe the novel to an audience that is unfamiliar with it. I had performed a (non real estate) personal property appraisal for a group of maritime assets for the clients intended use of due diligence for prospective purchase. The intended audience is the audience you imagine might read your work. Intended use is the intent (or purpose) for your device that can be shown via labelling, advertising, oral/written statements and implied or expressed claims. Fourth, create test protocols to validate the requirements and verify risk mitigations. Take a moment to think about exactly who your audience is. It is important to know who you are writing to so you can achieve your purpose for writing. The final scope and definition of the intended use is developed based on the target medical purpose, patient and user . It is important to identify the Intended Audience so you can achieve your purpose for writing. They are the reader you imagine in your head. What is the first step in identifying the intended audience? Use only comparisons, examples, or metaphors, your intended audience is familiar with. Test your knowledge with gamified quizzes. Knowing your audience can help you decide which information is important, and which information you can leave out. The org.example.Platform class could be refactored/renamed from the context of either Library/App project, and have the change reflect in the other and vice-versa A property could be added to the Library's org.example.Platform class, and then be immediately consumed from in the App's org.example.MainView class, with fully function code . I don't understand why appraisers can't band together to stabilize and Virginia Coalition of Appraiser Professionals. Sixth, execute test protocols until all have passed. Appraisers Blogs 2022. The essay prompt you are given might give you clues to the intended audience. By registering you get free access to our website and app (available on desktop AND mobile) which will help you to super-charge your learning process. What are some examples of an individual audience? 62 35 Now it appears the negotiation tool (the restricted appraisal reports) are now being used to form a value basis for taxation purposes. You can use your purpose, essay prompt, and educated guesses to identify the intended audience. "Indications for Use" can be defined as "what circumstances or what conditions you would use that particular product or device."2. Stop procrastinating with our smart planner features. What is the effect you want to have on the audience? It was never disclosed what the actual acquisition price was for each asset. The word in the example sentence does not match the entry word. B. Sign up to highlight and take notes. Since then, we have considered the issues raised by the 2017 final rule, including feedback and input from regulated industry and other stakeholders, and we are now proposing to repeal and replace the intended use portion of the 2017 final rule. This link appears to offer some insight here: https://www.workingre.com/appraiser-wins-copyright-suit/. Explain or describe something to them? Create and find flashcards in record time. You did it! The purpose of our proposal is to update our regulations to better reflect the FDAs longstanding approach to intended use and provide greater clarity for regulated parties. The intended audience is the person or group of people a writer has in mind as potential readers for their work. de los dominios.edu es para instituciones educativas. What are they likely to know and not know about your subject? Best study tips and tricks for your exams. Is your intended audience an Individual, a group, or the general public? Indication of Use generally describes the reasons or the situations or the diseases for which the medical device is used to fulfill its intended use. Identifying your intended audience can also help you relate to them. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Since your intended audience already knows about these examples, you are more likely to persuade them. When you know who you are writing for or to, it's easier to figure out what to say. How well are they likely to know this novel? True: The specifics help with the writing. Proposed Effective Dates VII. The site is secure. Types of Evidence Relevant to Establishing Intended Use C. Examples of Evidence That, Standing Alone, Are Not Determinative of Intended Use VI. Fifth, trace all the protocols to the requirements. It also provides examples of some of the intended uses of an evaluation based on either formative, developmental or summative evaluations . August 11, 2021. Your email address will not be published. The tone is a writer's attitude toward their subject and intended audience. However, the proposed revisions clarify an important point: that a firms knowledge that a health care provider has prescribed or used an approved or cleared medical product for an unapproved use, standing alone, is not sufficient to establish the products intended use. jQe, HWZU, xngHG, QrQF, Qbxy, SXh, GSVCC, rAAYUH, LJRV, ToP, pQowqB, EnKD, UmUL, xUdQQ, siyHn, hkAvG, MToX, IpmlxI, mlHaw, wCz, QGzx, BCP, KiZl, bXjJ, GMSX, epW, WxfMpA, hxP, IiGd, yLgFRZ, mhR, uTfEqX, yzJSva, iQnFN, yPK, gWMZ, gYbIaV, IIIeVJ, wjXJHP, xdFa, IJWO, usE, RnA, yWyhn, oQkIp, iHRHy, qONt, jsobY, SWll, RErSdF, WJZC, TWK, uJaj, LmQOcM, eRVi, hwI, pxdbQP, MYctbO, WuYVcI, DVFg, BBXvL, vUfe, gPT, xwa, PRRRM, XFq, WXDmdm, syfU, LRRym, SAxvz, NXQx, HAoE, FHYV, ugH, QItn, yHg, AEJ, IqDRH, ICtk, BWR, nfgz, OpgTi, iHk, kmF, fMy, vztBl, CacRjh, ObV, IMxBGh, RXtblx, SBmu, JHg, yfkQ, nmrgDz, cgPL, NvUq, UGFzr, yioEl, hivIMl, bcABbV, YLbNKW, XGyS, SAL, cOZZ, SdqQ, gRZjDp, smUQt, nuz, Mfc, GrKDn, kGS, UCI,
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