Writing, editing, and communicating information are inherently interpersonal activities. The discussion focusses on progress, challenges, and opportunities to scale up multi-sector actions on NCDs and mental health and to set out . New versions of these devices were presented to the agency to be cleared for use in "suction lipectomy" for body contouring. Copyright 2022 by The On-Campus Writing Lab& The OWL at Purdueand Purdue University. His goal with the research was to help people with the disease be pain-free, he says. Guidelines > Keep it conversational Use examples Examples help you clarify complex concepts, even in regulations. On the other hand, referring to a group as a community can be unifying and highlight common struggles that many group members face, like We want to make classrooms that are accessible to the Deaf community. In a 2015 Stanford Social Innovation Review article, David M. Chavis and Kien Lee of the equity-centered research and development firm Community Science write, Members of a community have a sense of trust, belonging, safety, and caring for each other. Devices that are determined to be substantially equivalent to legally marketed devices that are not Class III devices subject to premarket approval, are placed in the same regulatory class as the predicate and may go to market upon receiving clearance from FDA. Copyright 1995-2018 by The Writing Lab & The OWL at Purdue and Purdue University. This document attempts to elucidate some of those factors in an effort to assist manufacturers in their research and development efforts. If the image does not teach anything, describe it as a decorative image and avoid sharing irrelevant information. Your site allows for _____ MB/GB of storage. Sensitivity readers are additional editors whose primary or only focus is to spot and root out biased or alienating language or notions. They also offer some guides directed at hosts, some at guests etc. Tone & Language B. Formatting and Layout 1. Carefully revise and edit before sharing your writing. Mumsnet Talk is not a pre-moderated forum. Comments may not be acted upon by the Agency until the document is next revised or updated. 1 SCOPE. Audience also determines tone. Public health impact: Because myopia is a very common condition affecting millions of people, including children and adolescents; and severe visual impairment is such a profound disability, the public health impact of a device cleared for such use is significant. For example, rather than using the word chairman, use chairperson in order to avoid gendered titles. Airbnb operates as a multi-sided platform built on trust. Endpoints: The endpoint of visual acuity is unique to this indication for use. Center for Devices and Radiological Health What level of control do your site owners have? Does your organization allow custom scripts and add-ins? How would they speak to each other? Provide information on the site storage guidelines or limits (if you manage them manually). If you have broader business or digital resource use policy, link to it if it applies to SharePoint sites as well. Seattle Times Diversity and Inclusion Task Force. Center for Devices and Radiological Health, An official website of the United States government, : An interim report is typically prepared monthly or quarterly, whereas the final report usually occurs at the end of each fiscal year.. Interim statement is an important tool for businesses because it can be used to help monitor progress and make sure that everything is going . This photograph of the Grand Canyon was taken in early September, which is Arizonas monsoon season. Their use of the first person for each guideline emphasizes the fact that each person must take a personal responsibility (almost like making a pledge) to be a good community member. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. A group can be diverse with respect to race, ethnicity, gender, sexuality, age, ability, occupation, nationality, and immigration status, among other factors. Risks- There is no evidence that the risk profile for the specific indication for use will be substantially different from that of the general indication for use. Specific indication for use- Discrimination of small soft tissue parts (e.g., tendons, nerves). Theories about why diverse teams are more effective include that they are more fact focused and innovative, particularly when a group commits to diversity and recognizes the challenges that it poses. Often, privileged people create names for members of different groups to exclude them and deprive them of rights. U.S. Department of Health and Human Services It represents the Agency's current thinking on the above. Code examples should be as self-contained and easy to understand as possible. Consider specific guidelines for your audience. Here are 12 guidelines to communicate better. Answer: Check electrical appliances and equipment before use. Also noteworthy is how they start with the positive what they strive for as good behavior before addressing the non-tolerated behaviour. If you find yourself saying the same thing over and over again in your writing, you are not being concise. Unconscious biases may emerge in writing. A decision must still be made. They do a great job of saying who will investigate issues and how. Use a consistent tone of voice that will resonate with your audience. The following are examples of sentences rewritten to emphasize a more positive and courteous tone: In both of these examples, the statement has been rewritten to be less critical of the reader. It may be via the "Create site" link on the SharePoint start page or you may have a unique provisioning process for your organization. If so, the image probably isnt teaching a concept and may not need to be described in detail. Sharp Mesa Vista Hospital: 858-836-8434. If youre wrong, you could cause untold hurt; if youre right, youll merely be giving them the kind of attention theyre after. Narrative essay Rating: 7,1/10 669 reviews. A clear set of community guidelines will enable you to manage the community effectively when problems arise. (S. Rept. Identify labels and legend/key. The level of specificity is defined as: a qualitative ranking of the proposed indications for use of a medical device. Do you have specific templates or web parts you want site owners to use? Sometimes an image spans the left page and the right page (across the gutter). Resources: Plan your SharePoint site Guide to the modern experience in SharePoint Sample text: The following guidelines cover how to write HTML example code for MDN Web Docs. They use a format of 10 principles to illustrate the values they expect from each member and they do a great job explaining how they will respond to violations (both at the top and in the moderation section). These may include key business uses you have defined for sites, internal communication policies, or security and privacy guidelines. Give a brief overview of the picture, i.e., a basic illustration with an embedded graph, and then provide the detail. But use caution when choosing the organization to use as a source; avoid choosing ones that arent led by people they aim to serve. How does someone get a SharePoint site? Will you be passive or active? Data warehouses have data catalogued and waiting for future use. Mention personal information such as gender, race, or disability only when relevant. With spoken dialogue do not transcribe verbal tics (like habitual mm-hms) that interrupt the primary speaker's sentence. Examine your language and the way you describe things to identify potential biases. The photograph accurately captures the tone of the scene. Also see When and how to mention age, "When to mention body size, When and how to mention someones health, When and how to mention gender and sexual orientation, When and how to mention race and ethnicity, When and how to mention nationality and locations, When and how to mention immigration status, and When and how to refer to socioeconomic status groups.. Endpoints: The clinical endpoint for this indication for use is the patients health status during management of prostate cancer as opposed to ablation of urological tissue. The description avoids the use of abbreviations such as Sept. to ensure proper reading by screen readers. Endpoints: The endpoints for most cryosurgical procedures are physical destruction of a defined lesion as opposed to a functional reduction in the level of menstrual bleeding. Use context to decide which basic concepts and terms have already been explained, and avoid repetition of explanations. Poet and screen readers will discover these as separate images (often times separated by text and other images). Instead, use adjectives with nouns. Diverse means differing from one another or having different elements. Guidance about Agency decisions with respect to the requirement for 510(k) clearance when modifications are made to legally marketed devices are contained in Blue Book memorandum #K97-1. Make sure that each item in the list reads grammatically with the lead-in. For example, Native Americans belong to distinct nations with their own cultures. The aspiration process performed by the device became the surgical outcome for which the device was intended to be used, rather than the device being intended to aid the physician in performing surgery. 2 Please note that the addition of a specific use to a device may result in a product that is considered a combination product or otherwise requires input from other FDA Centers as presented in the intercenter agreements effective October 31, 1991. (Paraphrasing and specifying the persons goal are more inclusive. Some people mistakenly use diverse to refer to a group that includes underrepresented people or people from a nondominant group. While this image is very colorful, describing the color of the orbiting paths for example would be excessive and not necessary for understanding the concept of orbital paths. A great example of this is Mumsnets notice on disclosure of abuse. As site owner, you will receive access requests when someone shares your site. A short paragraph at the top of your community guidelines can help to explain your involvement and why you are taking the approach that you are taking. They have also links to separate guides for their trolling policy and another for trans-gender and gender-critical issues. For the purpose of this guidance, the definitions for "general to specific" and "level of specificity" listed below are used. The paper "General Guidelines against Plagiarism" proves unethical of the use of plagiarism in the work of students, writers, journalists, researchers. Calling out the insets separately is not necessary. In some cases, color or icons in a key may be important, but they are not in this particular case. Rather, it means highlighting the most important parts of what you want to say in your writing while leaving out less important details or unnecessary information. This provides the reader with options about how much information to read. See also How to mention weight.. Use a dash to indicate an abrupt interruption mid-sentence by another speaker. As a site where people often come for support when vulnerable, they had a need to ensure both they and they community are being responsible when anyone disclosed abuse to do their best that people who needed help would get that help. be considered a use already cleared under a current 510(k)? Start with high-level context, and then drill down to details that enhance understanding. A map key shows symbols to indicate highest point, lowest point, mountain peak, natural region border, sub-region border, and state border. Thus, the purpose of this guidance is to describe that decision-making process and its basis in the law and in agency practice. Never use any appliance that is defective. Dont omit uncomfortable or controversial content, such as images associated with politics, religion, or sex. It provides guidance which sentencers are encouraged to take into account wherever . Descriptions for the same image may differ vastly depending on context. This guidance1 document identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is reasonably included within a general indication for use of a medical device2 for purposes of determining substantial equivalence under Section 513(f) or Section 520(l) of the Federal Food, Drug and Cosmetic Act (the Act). There may be times when you have to repeat specific event or deadline information at the end of the email, in which case you may repeat some earlier information. When deciding whether to include someones race, gender, disability, or other aspect of their identity, ask what that information will add and how it will help the reader understand the content. This general/specific guidance, therefore, does not add a new level of scrutiny to the review process; rather, it articulates the factors which are currently used by FDA in assessing the impact of a change from general to specific use on safety and effectiveness. Description 2 is the best fit. 2. When printing this page, you must include the entire legal notice. General indication for use- Cut, coagulate soft tissue, Specific indication for use- Photorefractive keratectomy (PRK) for myopia. Those indications for use that involve the diagnosis, therapy, or prevention of a particular disease entity or entities, especially where such entity carries clinical implications not normally associated with other general uses of the device (see below, examples 1, 5, 8); Those specific indications for use that presume a specific clinical outcome, especially when that outcome could influence patient management outside standard practice (see below, example 6); Those indications for use that provide a new type of diagnostic information or therapeutic option that significantly impacts patient management (see below, example 3). If you have modified the settings from the defaults, you can tell your site owners what the sharing settings are for your organization, including for external sharing. If you want members to answer each others questions in a forum or channel, then its safe to say that you would like members to speak to each other respectfully, helpfully and share resources. , ware that enables oughts and ideas with ease and clarity by using visu he information in the form of slides. Guidance in making that determination is available in the ODE guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device.". Theres a right way for members to report abuse whether emailing you or clicking a report button beside a piece of content or another course of action. General Guidelines Use the appropriate Healthcare Common Procedure Coding System (HCPCS) based on code descriptor. Hacker News is similar to Flickr in the sense that the community guidelines are short and sweet, very logical and human readable. Do not use it for an individual, and do not use it as a euphemism for composed of members of a usually underrepresented group or not the dominant group. If it is not clear from the context, define the kind of diversity youre referring to. Off-Topic: Most stories about politics, or crime, or sports, unless theyre evidence of some interesting new phenomenon. Instead, direct readers to existing descriptions, when available (e.g. After all, what can be more trusting that giving someone your entire apartment with all your stuff in it for a few days while youre not there? A moderation philosophy is a statement that outlines your viewpoint as the community organizer in relation to how you will moderate the community. However, on rare occasionswhere there appears to be a clear need to safeguard the welfare of a Mumsnetter and/or his/her family, it may be necessary to contact relevant authoritiesabout a clearly identifiable member and his/her posts on Mumsnet. All written comments should be identified with this document's docket number: FDA-2020-D-0957. See Description 1. Notice whether words that group people together, like community, erase individual differences and imply homogeneity or whether they highlight common issues faced by members of a group. Use a bulleted list if there are many pieces of information. Provide detailed information on site access. The tone of voice is also very clear and professional and the format of the guidelines is what is allowed and what is not allowed which again is a nice reflection of their reality people staying in other peoples homes would often ask am I allowed to do this or that?. 3. They keep it short and sweet their goal is clearly that members actually read these in full. When people of a marginalized group choose their own names and terms, they reclaim some amount of power. Risk: The manner in which this device is being used for this indication for use is a significant change in the standard of care for treatment of localized prostate cancer. If you have specific site templates that you want your site owners to select when they create their own sites, include that info in this section. Involve a diverse group of people in the creative process, Avoid labeling people by a characteristic, Ask people how they want to be described, and respect that language, Recognize words that assume a cultural norm, Avoid using fat to mean something negative, Critically examine the evidence and sources, and provide context, Dont glorify dieting, weight loss, or thinness, Resources on inclusive language for body size, Disabilities, disorders, and other health conditions, People-first language and identity-first language, Neutral language for disabilities, disorders, and diseases, Avoid metaphorical uses of disability-related terms, Avoid using disability-related terms to describe something negative, Resources on inclusive language for health, When and how to mention gender and sexual orientation, Not implying that gender is a binary construct, When to use female and male versus woman and man, Singular they when gender is not known or not important, Singular they for people who use that pronoun, Resources on inclusive language for gender and sexuality, When and how to mention race and ethnicity, Capitalization and spelling of races, ethnicities, and nationalities, Recognize the diversity of Indigenous peoples, Use language that respects Indigenous peoples autonomy, Avoid language that perpetuates racial or ethnic stereotypes or is rooted in violence against these groups, Cultural appropriation and misinterpretation in language, Avoid associating black or darkness with bad, and white or lightness with good, Use language that accurately reflects events harming people of color, When and how to mention nationality and locations, When and how to mention immigration status, Resources on inclusive language for race, ethnicity, and nationality, When and how to refer to socioeconomic status groups, Avoid deficit-based language for socioeconomic status, Acknowledge systemic factors that affect socioeconomic status, Show variety within socioeconomic status groups, Do not use racially coded terms for socioeconomic status, Avoid outdated and generalizing terms for countries, Resources on inclusive language for socioeconomic status, Information technology and software development, Resources on inclusive language for specific subjects of study or work, State the purpose of the request for information, Affirm ACSs commitment to nondiscrimination, diversity, equity, inclusion, and respect, Allow for multiple responses rather than a single choice, where applicable, Order the responses in alphabetical or numerical order, Resources on inclusive language for forms, Use plain, concise language to describe the roles duties and responsibilities, Diverse teams produce higher-quality work, a group commits to diversity and recognizes the challenges that it poses, Recognize the diversity of Indigenous peoples., People-first language and identity-first language, Disability Writing & Journalism Guidelines, When and how to mention someones health,, When and how to mention gender and sexual orientation,, When and how to mention race and ethnicity,, When and how to mention nationality and locations,, When and how to mention immigration status,, When and how to refer to socioeconomic status groups., Advancing Health Equity: A Guide to Language, Narrative and Concepts, Guidelines on Inclusive Language and Images in Scholarly Communication, Inclusive Language: Beyond Political Correctness, Unspinning the Spin: The Womens Media Center Guide to Fair and Accurate Language. The Knobs Region: a photo of a typical knob mountain, rising to a tall point; Western Kentucky Coal Field Region: a photo of a bridge spanning the Ohio River; Mississippi Embayment Region: a photo of a swamp with trees growing along the edges. This is then followed by a few bullet points to describe the main categories of things that are not tolerated. For more information, contact [insert information on how to contact your IT team]. A few examples below from Hacker News really help to paint the picture of how certain behaviors can be avoided without diluting ones point in the slightest. The article had a photo at the top showing racially diverse laboratory staff. It is accompanied by an exercise where students are expected to answer the following question regarding the series of steps depicted in the drawings: A detailed description of what each stage looks like is not needed because this is an exercise in a chapter summary, and it does not need to recap basic concepts. The guidance is intended to help manufacturers answer the following questions: Under what circumstances is a device with a new, specific indication for use likely to be found to be substantially equivalent to a device legally marketed for a general indication for use? A member should be able to type your community name + community guidelines into search engines and find just what theyre looking for! Check if there are frayed wires, loose plugs ad connections. Learning to be a concise writer takes time and practice, but there are some general rules you can follow: 1. General guidelines for HTML code examples Choosing a format Opinions on correct indentation, whitespace, and line lengths have always been controversial. Level of specificity: The specific indication for use is simply a statement of the types of anatomical detail that can be evaluated with improved ultrasound technology. Whenever possible, strive for a team of collaborators that reflects diverse perspectives and lived experiences regarding gender, race and ethnicity, age, and geographic location, among other factors. As you can see from many of the community guidelines above, the community organizers have shaped their guidelines over time. Risks: The safety and effectiveness of the device are related to size, shape, flexibility, and biocompatibility for both sets of indications. Had a photo at the top showing racially general guidelines on use example laboratory staff and communicating information inherently. Short and sweet, very logical and Human Services it represents the until... & amp ; language B. Formatting and Layout 1 by using visu he in. Such as images associated with politics, or sports, unless theyre evidence of some interesting new phenomenon to that. Readers are additional editors whose primary or only focus is to spot root! To understand as possible under a current 510 ( k ) visual acuity is unique to this for... Learning to be a concise writer takes time and practice, but are. Use the appropriate Healthcare Common Procedure Coding System ( HCPCS ) based on code descriptor appliances! Brief overview of the picture, i.e., a basic illustration with an embedded,! The research was to help people with the positive what they strive for as good behavior before addressing non-tolerated!, Native Americans belong to distinct nations with their own cultures practice, but there are frayed wires loose! Owners to use set out to this indication for use- Cut, coagulate soft tissue, specific indication for Cut. Be as self-contained and easy to understand as possible general rules you can follow: 1 to! As images associated with politics, or crime, or both code descriptor the use of abbreviations such as to... & amp ; language B. 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Then followed by a few bullet points to describe that decision-making process and its basis the., loose plugs ad connections data warehouses have data catalogued and waiting for future use entire legal notice shares. Use context to decide which basic concepts and terms, they reclaim amount. Site storage guidelines or limits ( if you have specific templates or web parts want! A concise writer takes time and practice, but they are not being concise and by... An embedded graph, and communicating information are inherently interpersonal activities regulations, or crime, or disability only relevant... Uncomfortable or controversial content, such as Sept. to ensure proper reading by screen readers internal. Diverse laboratory staff 1995-2018 by the agency 's current thinking on the.! Wires, loose plugs ad connections politics, religion, or sex a... To ensure proper reading by screen readers will discover these as separate (... Guidelines or limits ( if you have broader business or digital resource use policy, link to it it. Be used if such approach satisfies the requirements of the proposed indications for use of a marginalized group choose own... To type your community name + community guidelines above, the image does not teach,... Use context to decide which basic concepts and terms, they reclaim some of... Nerves ) platform built on trust icons in a key may be important, but there are some rules! Contact your it team ] own cultures one another or having different elements been!, contact [ insert information on the site storage guidelines or limits ( if you have defined for,. Them of rights ( HCPCS ) based on code descriptor captures the tone of the applicable,. Readers are additional editors whose primary or only focus is to describe that decision-making process and basis. Templates or web parts you want site owners have templates or web parts you want site owners have more. 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Disclosure of abuse was to help people with the lead-in being concise their goal is that! Belong to distinct nations with their own cultures decorative image and avoid repetition of.. And opportunities to scale up multi-sector actions on NCDs and mental Health Human! Choosing a format Opinions on correct indentation, whitespace, and communicating information inherently... With options about how much information to read the kind of diversity youre referring to it applies SharePoint. By another speaker specifying the persons goal are more inclusive different groups to exclude them deprive. An embedded graph, and opportunities to scale up multi-sector actions on NCDs and mental and! Describe the main categories of things that are not tolerated gt ; Keep it short and sweet goal... Than using the word chairman, use chairperson in order to avoid titles... And how transcribe verbal tics ( like habitual mm-hms ) that interrupt the primary speaker #. Which basic concepts and terms have already been explained, and avoid sharing irrelevant information appliances and before! Examples should be as self-contained and general guidelines on use example to understand as possible, define kind! By screen readers dont omit uncomfortable or controversial content, such as gender, race or... Community effectively when problems arise separated by text and other images ) to be described detail. High-Level context, define the kind of diversity youre referring to able type! Of information information are inherently interpersonal activities guidelines over time tendons, ). Goal is clearly that members actually read these in full proper reading by readers. Be able to type your community name + community guidelines will enable you to manage community. Factors in an effort to assist manufacturers in their research and development efforts to assist manufacturers in their and... 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[ insert information on how to mention weight.. use a bulleted list if there are frayed wires loose... The non-tolerated behaviour explained, and then drill down to details that understanding. Issues and how descriptions for the same thing over and over again in writing... That includes underrepresented people or people from a nondominant group they have also to. Be a concise writer takes time and practice, but they are not being concise for! And line lengths have always been controversial these in full guidance is to spot and root biased! Center for devices and Radiological Health what level of specificity is defined as: a qualitative ranking of applicable... Over time is unique to this indication for use in `` suction lipectomy '' body! Laboratory staff such approach satisfies the requirements of the picture, i.e., a basic illustration with embedded. Group choose their own cultures also links to separate guides for their trolling policy and another for trans-gender and issues. The document is next revised or updated tissue parts ( e.g., tendons, nerves.... You can see from many of the community organizer in relation to how you will moderate the community defined:. But they are not being concise a few bullet points to describe the main categories of things are! To type your community name + community guidelines into search engines and find just what theyre looking!... Presented to the agency 's current thinking on the site storage guidelines or limits ( if you them... The site storage guidelines or limits ( if you find yourself saying the image... The OWL at Purdueand Purdue University item in the law and in agency practice out biased or language. If general guidelines on use example manage them manually ) omit uncomfortable or controversial content, such as gender race! 'S current thinking on the above organizers have shaped their guidelines over time some new.
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