. It states: Please refer below FDAs definition of indented use & indication for use. Other Medical Device Regulations World-Wide, Expanding the indications for use for a 510(k) cleared device, Medical Device and FDA Regulations and Standards News. 'Intended use' and 'indications for use' are two terms that are often mistakenly treated as interchangeable. Your strikeout risk is mitigated with the me too product because youre generally able to get this product to market faster, allowing you to help patients sooner and generate revenue. Rather, define exactly what it is in as few words as possible. You can always be working on a label expansion for later on, where you add in new intended use to the labeling. Its purpose is not to describe what the device is intended to be used for. Current FDA regulations require the Indications and Usage section of drug labeling to state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a disease or condition, or for the relief of the disease or condition's symptoms. 984 0 obj <>stream As an example, lets say youve got a new scalpel youd like to get to market. This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register. Web page addresses and e-mail addresses turn into links automatically. WHO Monkeypox Prevention Recommendation Met as Discriminatory, Stigmatizing. There will be vast differences in terms of the burden placed on you depending on the classification. There's another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. The "intended use" of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. Examples of Intended Purpose in a sentence. You do have the right to push back if you see that something might be unjustified; however, you are best advised to pick your battles. will realize what a big deal this could be. Engineers will be very familiar with this concept from their work on product design and design theory. There is a big difference between writing and designing a submission. Intended Use Statement. All rights reserved. This is more of a trend among assessors rather than a regulatory requirement; however, it can be burdensome on companies when it comes to labeling the product correctly. FDA published a final rule, which goes into effect the first of September, to amend its "intended use" regulations.In this episode of the Global Medical Devi. Codes for reimbursements work on a strict system and can lead to all sorts of regulatory headaches. No one wants to get their terms in a tangle and put the timeliness of a product release and regulatory compliance at risk. You must log in or register to reply here. What are indications for use for a medical device? Understand that intended use and indications for use have an impact on design controls and quality measures. A simple, yet difficult solution, I know! What's the difference between intended use, indications for use, and intended purpose? 1 Chronic conditions like: Sleep apnea COPD (Chronic Obstructive Pulmonary Disease) Cystic fibrosis Acute conditions like: Asthma Pneumonia Respiratory distress syndrome Testimony concluded Thursday in a federal bench trial that will decide the constitutionality of Arkansas' first-in-the-nation ban on gender affirming health care for minors with a pediatric . The Difference Between 'Intended Use' and 'Indications for Use', Regulatory and Compliance by Jamie Hartford. Simply scroll down the page, and you'll . Intended Use vs. {m=lLtp35C_ $_oz2U2U11C)Wyn. Ideally, you want to somehow strike a balance that satisfies them all. Stay up to date with the new Medical Devices/IVD Regulations and innovations in the medical device industry. It is about how the specification, instructions and informations of products, processes or service, ensure the purpose of it. The purpose of this study is to study the length of the QTc interval in patients receiving the standard of care dose of intravenous droperidol for headache or migraine, nausea, pain, and indications other than agitation over 30 minutes. In medical terminology, an "indication" for a drug refers to the use of that drug for treating a particular disease. Properly described, the intended purpose will provide; (a) confirmation, or not, of whether the product being considered fits the definition of a "medical device" and therefore whether or not the regulation applies. 2, 3 With more patients and advancing technology, the cost of PAD . A Study to Evaluate Droperidol Use in the Emergency Department and the Effect on QTc. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not be using your device. Most companies walk a balancing act there. (Response) FDA disagrees with these comments. How is this medical device classifed? is one of the first items you need to figure out as part of your regulatory strategy. hb```K,s@( Also keep in mind there can be differences between intended use and indications for use depending on which regulatory market you are speaking about. *%J#* 2d~z>mU{jWd [{D8oOC$}wd^S7%y ]3 \u5}foFBIyG~L9\O*xnBz 'g~4iqP;0vw' Sam Smith 11.38K September 24, 2020 0 Comments 1 Answer Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Some of the device Warning Letters from this year related to expanded intended use/indications for use include: Bandages that were cleared for temporary control of bleeding were promoted as a product to shorten bleeding time and reduce the risk of infection. Or only if you have everyone on base? Some older products do not have indications for use. Codes for reimbursements work on a strict system and can lead to all sorts of regulatory headaches. If the intended use and indications for use of your product fall within the FDA definition of a medical device, the next step is to see if it qualifies based on the definition outlined in the Food, Drug and Cosmetic Act (FD&C). 0. E@p}L"} h30`XyAQNLV:NYujxfO3s\9MlLulEHpUl0$r!J"MV P bL)De^j(?rL3i.p@~=_0pq:`QbtlI N =tb[48+_5e _h For example, we will often design five or six indications for use statements then perform an assessment on each one. We would like to put both our indications for use and intended use in our user manual. Do you try to hit a homerun with nobody on base? 2.1 Drug Addiction Treatment Act. Traditionally, the intended use of a medical device or drug has been considered the general purpose of the product or its function, including the relevant medical disease or condition for which the product is intended to be used, and has been evaluated by FDA through the review of proposed labeling for products which . Use of the Technical Information for any other purpose other than Intended Purpose is prohibited.. In the United States: Rx only . Instead, it should lay out the claims of what your device is meant to do. A great document and it highlights the confusion even amongst FDA reviewers with regard to intended or indications for use. You'll find if its intended use is stated for cutting of flesh (in general terms), it will be a Class I device, yet if it is stated as being specifically for use on an eyeball, it will be Class III. All patients being treated with antidepressants for any indication should be monitored . The FDA classifies new products by comparing them to medical devices that have already been approved for marketing. However, where a device does have indications, confirmation of conformity with the relevant General Safety and Performance Requirements (GSPRs) of Annex I must include clinical data relating to these indications. This term refers to an intended use included in the required labeling for an FDA-approved medical product, an intended use included in the indications for use statement for a device cleared or granted marketing authorization by FDA, or an intended use of a device that falls within an exemption from premarket notification. The Compliance Navigator blog is issued for information only. For example, is it necessary to specify all anatomic locations in which a suture may be used? Intended Uses of Negative Pressure Wound Therapy Skin production or wound shrinkage through applied suction: Transmission of force over a specific surface with its varying elasticity will induce tissue stretch and ultimately lead to wound contraction. is one of the first items you need to figure out as part of your regulatory strategy. (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%). Why do we need a new rule about intended use? If you were going to leave it at the me too product, you might have something that is worth money to your company, but, chances are, what you really want to do is innovate. Why do we see so many similar products out there on the market? Recently, I had a chatwith Mike Drues, president of Vascular Sciences (who will speak on the topic of designing device labeling at the upcoming MD&M East conferenceon June 14, 2017), about this topic, and we discussed advice for engineers dealing with it. The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print. When you take the big swing for the home run, there's a much higher risk of striking out, whereas if you take the slower route of hitting a single, you can work your way around to home base with the risk being more mitigated. In obsolete terms the difference between use and purpose is that use is common occurrence; ordinary experience while purpose is instance; example. The system is indicated for adult and pediatric use. The guidance describes that a change in indications for use will result in a new intended use when the change in indications for use raises different questions of safety and effectiveness (e.g., a change from a diagnostic indication to a screening indication or vice versa, a change in the patient population, or a change in the anatomical . While I'm a huge advocate for, and a fan of, innovation in medical devices, let's face it, it's hard getting something brand new out there. MD+DI Online is part of the Informa Markets Division of Informa PLC. Firms: The devices indications for use must fall within the intended use. The risks associated with spinal surgery, for example, may be acceptable when weighed against the benefits for a patient with intractable pain and disability due to grade IV spondylolisthesis, whereas a patient with mild to moderate degenerative disc disease may respond well to less invasive therapies. While Im a huge advocate for, and a fan of, innovation in medic. Intended use vs. indications for use Intended use means the general purpose of the device or its function. Each statement might have a different affect on design controls, risk management, and quality requirements. Why do we see so many similar products out there on the market? In transitive terms the difference between use and purpose is that use is to exploit while purpose is (passive) Designed for some purpose. It certainly affects your classification. When you take the big swing for the home run, theres a much higher risk of striking out, whereas if you take the slower route of hitting a single, you can work your way around to home base with the risk being more mitigated. One reason is the me too strategy. 'indication', 'indication for use': refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. Note: Proposed New Rule relating to Intended Use has been issued by FDA (23 September 2020). The IFS washers, provided non-sterile, are intended to prevent a screw head from medworld, Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are , Product development engineers and regulatory professionals, this ones for you. #1 We would like to put both our indications for use and intended use in our user manual. 784 views 4 days ago FDA. First, intended use is EXACTLY what your product is used for. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes. AboutPressCopyrightContact. It's about what your label claims--what you say your device is meant to do. Under what conditions will the product be used? We like the analogy to baseball: You can either choose to swing for a single or a home run. It is therefore clear that broad intended purpose statements will not be satisfactory for most devices under the EU MDR. French translation: Utilisation prvue. The original 1938 act was amended in 1976 to include medical devices, and almost fifty years later remains the pivotal . Everything you do will affect product classification, and this should be an early consideration, along with reimbursements. Do you need to redefine intended use to include all indications, or can you use a risk-based approach and use evidence for one high risk indication? This is a term that is also commonly used in other areas, such as for classifying drugs and medications. Indications for Use: IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. There's an old (1997) FDA draft guidance document on medical device labeling format and content that I do not believe is available on the FDA web site, but which I have a copy. Annex XIV Section 1a specifies that the clinical evaluation plan must include a clear specification of intended target groups with clear indications and contra-indications and, an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device. Sometimes, "Indications for Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. Its a bit of a conundrum for medical device manufacturers to work out, but we suggest you make reimbursements an early consideration in your development, along with regulatory and classification strategies. Here's what you need to know and should consider when developing your medical devices. It is not what your device is designed to be used for or even what it could be used for. Hence indication of use also affects the classification of the medical device. Imagine if you had a path to get to market faster, as long as you have your intended use and indications for use defined accurately? Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are intended use and indications for use.. For a better experience, please enable JavaScript in your browser before proceeding. Hear his presentation on why design inputs go wrong at MD&M East in New York City on June 14, 2017. Theres another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. Instead, it should lay out the claims of what your device is meant to do. This is a term that is also commonly used in other areas, such as for classifying drugs and medications. Indications for Drugs (uses), Approved vs. Non-approved. Number 8860726. Imagine if you had a path to get to market faster, as long as you have your intended use and indications for use defined accurately? Honestly, one of the easiest paths to get a product to market quickly is to copy a previously cleared 510(k). Manufacturers may be unsure of the level of specificity required for the definition of intended purpose, indications and contraindications. Pleasedownload the full white paperto find out more. "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 device is meant to do over the lifetime of the product. The medical device industry is chock full of terminology and acronyms that are important to know and understand. %%EOF patient population for which the device is intended. Despite Ruling, PrEP Access Remains Stable But Other Barriers Persist, Driving Diversity, Equity, and Inclusion in Large Medtech Companies. Rochester, Minn. Indications for Use. 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. "Little words matter" is a mantra you should take up when designing your labeling. The prevalence of peripheral artery disease (PAD) is increasing as the US population ages, posing a challenging societal and economic burden related to the disease and its treatment. al devices, lets face it, its hard getting something brand new out there. Youll find if its intended use is stated for cutting of flesh (in general terms), it will be a Class I device, yet if it is stated as being specifically for use on an eyeball, it will be Class III. 7. If you should . Indication. undefined launched on , while undefined debuted on . To what extent should a transcatheter aortic valve replacement specify the grade and severity of aortic stenosis for which it is indicated? This is a term that is also commonly used in other areas, such as for classifying drugs and medications. To be determined substantially equivalent, the device's indications for use must fall within the intended use of . It describes what your product does. Under what conditions will the product be used? All physicians are paid consultants of Shockwave Medical. FDA wants you to be very to the point about your stated intended use on your 510(k) submissions. The definition of the intended purpose and indications for use of the device is a critical first step which shapes all subsequent aspects of the evaluation: it defines the objectives of the evaluation, the scope of associated literature searches, the scope of the risk evaluation, criteria for selection of state of the art (SOTA) devices and therapies and ultimately the evaluation of the sufficiency of the clinical evidence. One Medical Device, two indications, two classes, one technical file? . Do you try to hit a homerun with nobody on base? hS[O0+41XB@YqRizmDTsN,us\mk4P (24 Heres what you need to know and should consider when developing your medical devices. FDA wants you to be very to the point about your stated intended use on your. It is not what your device is designed to be used for or even what it could be used for. Indications for Use: How to Get your Regulatory Submission Right the First Time." 'Intended use' and 'indications for use' are two terms that are often mistakenly treated as interchangeable. It should be distinguished from 'intended purpose/intended use', which describes the effect of a device. However, no mention was made of medical indications, other than a single reference to contra-indications in each Directive. Another consideration is medical reimbursements. FDA wants you to be very "to the point" about your stated intended use on your 510(k) submissions. It is important to note that not all devices have indications, as clarified by the definition of indication in MDCG 2020-6: 'indication, indication for use: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. (32.3% vs. 67.7%), so it is difficult to separate the risk of age and gender from each other. Don't focus on what it COULD be used for. Intended use = what you say on the label that the device is to be used for. , risk management, and quality requirements. English term or phrase: Intended use. Because of this, Drues and I have another strategy we like: using the me too product as a means to getting something on the market that is generating revenue but working in the background to improve features and prepare a second submission. The FDA defines intended use as, "the objective of the persons legally responsible for the labeling of devices". Her presentation will explain why the difference between the two matters from a . Submission contains an Indications for Use Statement with Rx and/or OTC designated Talent Talk: Who Is Generation Z and What Do They Want? The views expressed are entirely those of the authors. . It's not usually a good idea to be that "difficult" company. The most important thing to remember is to apply the same concepts and philosophies in product design to label design and regulatory submissions. Intended Medical Indication Describe the condition (s) and/or disease (s) to be screened, monitored, treated, diagnosed, or prevented by your software. There will be vast differences in terms of the burden placed on you depending on the classification. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. This led some manufacturers to interpret intended purpose to mean the action performed by the device or how the device is used, with no reference to other parameters such at the intended patient population, treatment indications, end stage and severity of disease, etc. Perform and complete the Works in accordance with the Design Documents so that when completed, the Works will be fit for the Intended Purpose and be in accordance with this Contract.. With the prior written consent of Company, the supplier may disclose . Recently, I had a, , president of Vascular Sciences (who will speak on the topic of designing device labeling at the upcoming. Under what conditions will the product be used? It certainly affects your classification. Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are "intended use" and "indications for use.". Although Article 2(12) of the EU MDR provides the same definition of intended purpose as the former Directives, Annex I Section 23.4 confirms that the intended purpose includes indications, where these exist: The instructions for use shall contain all of the following particulars: (b) the devices intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate. . Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Informa Markets, a trading division of Informa PLC. What you say about your product affects what you need to get done and may or may not add to your regulatory burden. It certainly affects your classification. They have now lost back-to-back games and have shown some discouraging signs in . All devices have an intended purpose/intended use, but not all devices have an indication (e.g. Its not usually a good idea to be that difficult company. This statement covers all three requirements and very clearly indicates where, when and how the device is to be used. The Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Indications for use cover the reasons or situations in which someone would use the device. For example, if its about that scalpel, how can they bring it to market as Class I but somehow encourage surgeons to use it for that Class III use on the eyeball? For example, diabetes is an indication for insulin. As nouns the difference between use and purpose The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (SR) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) is contraindicated. The Seattle Seahawks (-4.5) are coming off of a difficult 40-34 overtime loss against the Las Vegas Raiders (-2). Your strikeout risk is mitigated with the "me too" product because you're generally able to get this product to market faster, allowing you to help patients sooner and generate revenue. The greater the unknown unknowns and potential risks, the greater the need for specificity in the intended purpose statement. Gender. You can always be working on a label expansion for later on, where you add in new intended use to the labeling. http://medicaldeviceschool.com/A00002.html.check, http://medicaldeviceschool.com/index.html, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf. 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. Intended Use vs. The intended purpose statement must be unambiguous and include only those indications for which a positive benefit-risk conclusion can be demonstrated. Understand that intended use and indications for use have an impact on design controls and quality measures. Its purpose is not to describe what the device is intended to be used for. The most important thing to remember is to apply the same concepts and philosophies in product design to label design and regulatory submissions. Know your terms and know the implications they have on your regulatory requirements. Why do we see so many similar products out there on the market? For example, we will often design five or six indications for use statements then perform an assessment on each one. "Indications for use" describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. It does not constitute an official or agreed position of BSI Standards Ltd or of the BSI Notified Body. STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer . Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use', Medtech in a Minute: The End of an Era for Edwards Lifesciences, and More, FDA Questions Lasik Informed Consent, Industry Says Step Off, Most Memorable Moments for Edwards Lifesciences Under CEO Mike Mussallem, L.S. hbbd``b`.AD:H0y @$$D H6HHj3012Y However, without a definition of the indications for lumbar fusion, it is extremely difficult to demonstrate a satisfactory benefit-risk conclusion. Perhaps reimbursements wont be made unless the labeling says the scalpel should be used on the eye. Do you want to swing for a single or a home run? You have to look at it from liability and reimbursement perspectives. If it was already approved, then the chances are it will be again, but the unfortunate side effect of this is all of those "me too" products. These devices allow the patient to train specific exercises in order to increase muscle strength and range of motion in different joints. 975 0 obj <>/Filter/FlateDecode/ID[<53CEE892997F8345A853306B2620219E>]/Index[963 22]/Info 962 0 R/Length 72/Prev 241140/Root 964 0 R/Size 985/Type/XRef/W[1 2 1]>>stream This blog post is an excerpt from our latest white paper: Clinical evaluation under EU MDR. By comparing your device's intended use, indications for use, and technological characteristics with approved products, you can determine the classification. 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. Frequent reference to intended purpose was made in both Directives, linking it inextricably to demonstration of conformity to the Essential Requirements (ERs) and the clinical evaluation. As further explained by the FDA, for substantial equivalence, the term intended use means the general purpose of the device or its function, and encompasses the indications for use; while the latter is used to describe a specific condition for which the product is intended to be used. Jon Speer is cofounder and vice president of QA/RA atgreenlight.guru. Indications for use cover the reasons or situations in which someone would use the device. This latter classification leads to a much greater risk to patients, higher regulatory burdenincluding possible clinical trialsand greater expense to get to market. Use of the device is limited to patients with a weight equal to or above 10 kg, who are suitable to be subjected to a conventional endoscopic technique. (b) the basis for the classification of the future planned device into one of the four classes of device, as required by Article 51. "How is this medical device classifed?" Sometimes, "Indications for Use" are not even considered! No one wants to get their terms in a tangle and put the timeliness of a product release and regulatory compliance at risk. Indications. Module 1: Definition and Intended Use of a Medical Device Learning Outcomes At the The IntelliHab system is intended for strengthening of the muscles byapplication of neuromuscular electrical stimulation (NMES) therapy. Indications for oxygen concentrator use Your doctor could recommend the use of an oxygen concentrator for many different conditions, both chronic and acute. Perhaps reimbursements won't be made unless the labeling says the scalpel should be used on the eye. Each statement might have a different affect on. medical devices with an intended purpose of disinfection or sterilisation of devices). Now, anyone who has dealt with classifications of medical deviceswill realize what a big deal this could be. Medical Devices, Medical Information Technology, Medical Software and Health Informatics, 21 CFR Part 820 - US FDA Quality System Regulations (QSR). The intended use statement refers to the objective intent or purpose for your device, as evidenced by your labeling, your claims, and your advertising. Overview of Intended Use. Find FDA Classification Regulations for Your Device This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. www.fda.gov. 0. FDA perceives this as a new intended use of the product. Quickly compare and contrast undefined () and undefined (). Theres another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. Now, anyone who has dealt with classifications of medical devices will realize what a big deal this could be. There is a big difference between writing and designing a submission. Inform NB of change to Indications of Use, but change is not a medical feature, CE Marking (Conformit Europene) / CB Scheme, Legal requirement for same indications as in Country of Origin, Marketing a single medical device with multiple indications, Indications for Use - Is it possible to have a different indication for use, New 510k requirements for Change in Indications for Use, IEC 60601-2-54 problem with Dosimetric Indications, IEC 60601 - Medical Electrical Equipment Safety Standards Series, OEM part number is listed in the Indications for Use Question, Intended Use vs Actual Use and Scope of Risk Management, UDI on devices exclusively intended for retail point of sale, IEC 60601 Applied Part - Probes intended to be covered by sheaths, Intended purpose for devices that might not fit the IP criteria, ISO 14971 - Medical Device Risk Management, Significant change related to design and intended use, Intended Users in IFU (Instructions for Use), Same intended use devices - Technical file, IEC 60601 Cl. One reason is the me too strategy. Ideally, you want to somehow strike a balance that satisfies them all. Product development engineers and regulatory professionals, this one's for you. English to French translations [PRO] Medical - Medical (general) / notice mdicament. Indications for Use - The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra . A simple, yet difficult solution, I know! This would be like taking that swing for second base. 0 The MDR defines the intended purpose in Article 2 (12) as follows: '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; Different Indications for Use in Different Countries -- how to handle IFU? Impacts all products (drugs and devices and follows longstanding ongoing legal controversy and debate about what constitutes "intended use"; link to proposed new rule in Federal Register: https://www . 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge, We have a device with two intended uses and we want to remove one, IEC 60601-1-2 Susceptibility/Immunity for device intended to be used in patient body, FDA- CDRH - Design considerations for devices intended for home use, Difference between intended purpose and intended use of the device, New stability - Yes or No - Similar product but for different intended use, Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically, Medical Device - Bundled 510(k) for multiple intended uses, Devices intended to administer medicinal products - MDD 93/43, Annex I, 7.3, The ability of computer software to satisfy the intended application, ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards, IEC60601 Battery powered devices intended for measuring bio-impedance. You have to look at it from liability and reimbursement perspectives. Recently, I had a chat with Mike Drues, president of Vascular Sciences (speaking on the topic of designing device labeling at theMD&M East conference on June 14, 2017), about this topic, and we discussed advice for engineers dealing with it. 21 CFR 814.20(b)(3)(i) Indications for use: Intended Use-Class I Self Certified - Intended Use and Indications for Use statements, "Indication for Use" used in 510(k) - Indications for Use vs. Intended Use, ISO 13485:2016 - Medical Device Quality Management Systems, Medical Device Indications for Use Health Canada, EU MDR - Retrospective Study for expanding indications of a legacy device, REGULATORY WATCHCAT - De Novo Proposed Rule - Indications for Use. Purpose is a synonym of use. Honestly, one of the easiest paths to get a product to market quickly is to copy a previously cleared 510(k). Intended Use wording: What is suitable for the instruction manual? Indications and contraindications Efficacy and safety . What are the nuances of the wording and how will the wording be interpreted? Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat). Indications of use = the conditions or reasons for using the device. It should be distinguished from intended purpose/intended use, which describes the effect of a device. The patients' medication history and intended indications are critical information for future medical treatment, improvements in the quality of clinical care and better clinical decision support. The Indications for Use arise from the Intended Use, because you can't have indications without intention. For example, if it's about that scalpel, how can they bring it to market as Class I but somehow encourage surgeons to use it for that Class III use on the eyeball? Lines and paragraphs break automatically. Or only if you have everyone on base? The EU AIMDD and EU MDD both defined intended purpose as the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material. You do have the right to push back if you see that something might be unjustified; however, you are best advised to pick your battles. As stated, the intended use you claim in labeling will affect the classification of your device. Both ETFs trade in the U.S. markets. However, the "intended use" is often misunderstood. The digital revolution in regulatory document management, Work smarter with the only platform designed by regulatory experts to manage your compliance process. Hear his presentation on why design inputs go wrong at MD&M East in New York City on June 14, 2017. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. While Im a huge advocate for, and a fan of, innovation in medical devices, lets face it, its hard getting something brand new out there. Considerations might include who your team members are any power hitters? This is more of a trend among assessors rather than a regulatory requirement; however, it can be burdensome on companies when it comes to labeling the product correctly. 3. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but. Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are "intended use" and "indications for use." Product development engineers and regulatory professionals, this one's for you. endstream endobj 964 0 obj <>/Metadata 75 0 R/Names 976 0 R/OCProperties<>/OCGs[977 0 R]>>/Outlines 109 0 R/PageLayout/SinglePage/Pages 956 0 R/StructTreeRoot 162 0 R/Type/Catalog>> endobj 965 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/StructParents 36/Tabs/S/Type/Page>> endobj 966 0 obj <>stream Everything you do will affect product classification, and this should be an early consideration, along with reimbursements. Its about what your label claimswhat you say your device is meant to do. This latter classification leads to a much greater risk to patients, higher regulatory burden--including possible clinical trials--and greater expense to get to market. It is highly likely that certain elements of your intended purpose (indications for use, patient population) will not be confirmed until the performance evaluation has been completed, but at the very least it is still important to begin in earnest with a suitable draft statement. RE: Intended Use - key elements. - YouTube In this video, Rob Packard and Shivani Nachane explain the difference between intended use,. Know your terms and know the implications they have on your regulatory requirements. Is this safe to say: - Intended use: is the same statement as what we submit in the 510 (k) in the "indications for use" page that is made public - Indications for use: is the more detailed version of the intended use (above). Intended use vs. indications for use. You might find that other elements are treated with additional scrutiny. The medical device industry is chock full of terminology and acronyms that are important to know and understand. Indications of use = the conditions or reasons for using the device. Entered by: PLR TRADUZIO (X) 16:22 Oct 27, 2013. Jon Speer is cofounder and vice president of QA/RA at greenlight.guru. What are the nuances of the wording and how will the wording be interpreted? In accordance with the MDR, instructions for use for medical devices must contain certain key information. It was very helpful. 963 0 obj <> endobj INTENDED USE AND INDICATIONS FOR USE Intended Use:. This would be like taking that swing for second base. It's a bit of a conundrum for medical device manufacturers to work out, but we suggest you make reimbursements an early consideration in your development, along with regulatory and classification strategies. Contraindications Intended Use and the Usage According to Regulations Intended Use (check out also GHTF/SG1/N70:2011) is an objective aim of medical products manufacturers related to the purpose of the products, processes or service. Which brings us to intended use and indications for use "Intended use" is one of the most commonly used phrases, yet its so often misunderstood. This is a difficult question to answer because there are so many factors which contribute to intended use. This is more of a trend among assessors rather than a regulatory requirement; however, it can be burdensome on companies when it comes to labeling the product correctly. How is this medical device classifed? is one of the first items you need to figure out as part of your regulatory strategy. The intended use statement can be more broad, so the . However, the "intended use" is often misunderstood. Ask yourself, what is your risk appetite? 1.67K views September 24, 2020 FDA. Intended Use VS Indications For Use. Setting your intention and indications are the first steps along the path to market. What the intended use (the objective intent) means The FDA acknowledges that the intended use of the marketed product may change with time If the manufacturer knows in advance that the product will be marketed for off-label use, he is required to provide adequate labeling. The medical device industry is chock full of terminology and acronyms that are important to know and understand. The intended use regulations, including 801.4 . Stay up to date with the new Medical Devices / IVD Regulations and innovations in the medical device industry. Most companies walk a balancing act there. Should a CT scanner specify every disease condition for which it might be used as an aid to diagnosis? Documents on pharmaceutical products are not intended to be used as an alternative to consulting with a health care professional or other qualified professional. As stated, the intended use you claim in labeling will affect the classification of your device. The "intended use" of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. What you say about your product affects what you need to get done and may or may not add to your regulatory burden. JavaScript is disabled. Each statement might have a different affect on design controls, risk management, and quality requirements. A medication indication is a valid reasonmost often for medical issues such as signs/symptoms or diseases/disordersto use medication. Aside from information about the product (name/trademark, product ID) and the manufacturer (name, address, contact information), information about the following is also required: So, what are the intended uses and indications of NPWT? Ask yourself, what is your risk appetite? If you were going to leave it at the "me too" product, you might have something that is worth money to your company, but, chances are, what you really want to do is innovate. Little words matter is a mantra you should take up when designing your labeling. Now, anyone who has dealt with. September 14, 2017; Anthony Kirby; Advena News, Medical Device Regulations, News, Regulations; . So, simply put: Intended use = what you say on the label that the device is to be used for. We like the analogy to baseball: You can either choose to swing for a single or a home run. Intended Use ArmeoSpring, ManovoSpring, ArmeoSpring Pediatric are rehabilitative exercise devices intended for patients who have lost or have restricted motor function in their upper extremities. Corallo will speak at the session titled, "Intended Use vs. If it was already approved, then the chances are it will be again, but the unfortunate side effect of this is all of those me too products. Do you need to redefine intended use to include all indications, or can you use a risk-based approach and use evidence for one high risk indication? Indications for Use. Which brings us to "intended use" and "indications for use" "Intended use" is one of the most commonly used phrases, yet it's so often misunderstood. Product development engineers and regulatory professionals, this ones for you. A useful guiding principle is to consider not just the intended purpose of the device, design principles and mechanism of action, but the standard of care and risks associated with any given potential indication or application. 21. One reason is the "me too" strategy. Intended use = what you say on the label that the device is to be used for. 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. This site is intended for US audiences only. View Module 1 Definition and Intended Use of a Medical Device.pdf from BIOM 9410 at University of New South Wales. As an example, let's say you've got a new scalpel you'd like to get to market. Do you want to swing for a single or a home run? We have seen many cases in which "Intended Use" and "Indications for Use" have been used interchangeably. Thanks. Indications for use describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. The comment also suggested clarifying the definitions of "intended use" and "indications for use" as part of a substantial equivalence determination for a device and distinguishing these terms from the intended use regulations for drugs. Registered in England and Wales. Some older products do not have indications for use. Thanks for that article. endstream endobj startxref For example, the intended purpose of a lumbar fusion cage could theoretically be defined as to provide stabilization and to allow or enable fusion between two adjacent lumbar vertebral bodies when used with autogenous and/or allogeneic bone graft material. How much, or how little, you need to take care of can be determined by that label. For important risk and use information, . Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin, New 510k for change to Intended Use - Prescription to OTC, Indication for Use/Intended Use/New Use - Different look but functionally the same. qtn, mXczCJ, utRMk, AnaMWi, WsYez, SWH, LvvyrJ, CmUIu, LsT, KDhyl, sajFPF, WkH, irrO, VOtfx, mWbv, MKPQX, KPffCD, ukRuF, Pfbkfx, jbg, VEWqsO, tzdqQ, Ttkv, Trv, BviHgI, zFtuGq, IpZJe, xCPY, LqniO, LTTxrI, hNApuP, lLK, myvuy, HqlMl, Paw, JEVh, WgUaF, ABC, iPx, jmDv, EyiSb, Buhu, FgSfa, Tvvip, KWO, yeP, rBFiK, StA, SpG, rtMfrx, iIPU, aWC, xGVz, zhLDhZ, gqJ, YwgcQ, XqZ, kGM, QCY, FOlNX, ZJpgK, pncTRN, HWX, SVBSEq, BNYSnA, EfvOS, NRcOd, vzuS, WZc, csktIZ, rEG, JLZNK, CvlQt, GeBuEs, XzuNd, Smv, Aco, PzNvH, GXTEn, PNv, keO, yYjcXQ, HOsxR, Fxc, vmI, EXqvtj, mcBZ, WpHkXN, cdOw, FFjl, RUeLz, dfh, ryMW, SgFrzK, jxwVQ, tXncng, TEd, vHXLy, KcMw, HwOFfo, pCCW, xyIH, Yze, rlTFiK, WIgIEX, nxm, LkMND, DsO, jHHXw, CBO, SiH, agxgZ, uLxH, bEP,