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. Registered in England and Wales. 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 digital revolution in regulatory document management, Work smarter with the only platform designed by regulatory experts to manage your compliance process. hS[O0+41XB@YqRizmDTsN,us\mk4P (24 Hence indication of use also affects the classification of the medical device. Do you want to swing for a single or a home run? {m=lLtp35C_ $_oz2U2U11C)Wyn. The devices indications for use must fall within the intended use. In medical terminology, an "indication" for a drug refers to the use of that drug for treating a particular disease. This is a term that is also commonly used in other areas, such as for classifying drugs and medications. There is a big difference between writing and designing a submission. Number 8860726. You have to look at it from liability and reimbursement perspectives. Is this safe to say: - Intended use: is the same statement as what we submit in the 510 (k) in the "indications for use" page that is made public - Indications for use: is the more detailed version of the intended use (above). A simple, yet difficult solution, I know! Perform and complete the Works in accordance with the Design Documents so that when completed, the Works will be fit for the Intended Purpose and be in accordance with this Contract.. With the prior written consent of Company, the supplier may disclose . "How is this medical device classifed?" E@p}L"} h30`XyAQNLV:NYujxfO3s\9MlLulEHpUl0$r!J"MV P bL)De^j(?rL3i.p@~=_0pq:`QbtlI N =tb[48+_5e _h STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer . 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. %PDF-1.6 % As stated, the intended use you claim in labeling will affect the classification of your device. 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 . However, the "intended use" is often misunderstood. Aside from information about the product (name/trademark, product ID) and the manufacturer (name, address, contact information), information about the following is also required: 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. 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. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Do you try to hit a homerun with nobody on base? Pleasedownload the full white paperto find out more. 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. 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. 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. For example, we will often design five or six indications for use statements then perform an assessment on each one. Indications for use cover the reasons or situations in which someone would use the device. . What you say about your product affects what you need to get done and may or may not add to your regulatory burden. 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. - YouTube In this video, Rob Packard and Shivani Nachane explain the difference between intended use,. 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. Some older products do not have indications for use. AboutPressCopyrightContact. Intended Use & Indications - Hocoma ArmeoPower Intended Use The ArmeoPower is a rehabilitative exercise device intended for patients who have lost or have restricted motor function in their upper extremities The ArmeoPower supports specific exercises for increasing the strength of muscles and the range of motion of joints. Jon Speer is cofounder and vice president of QA/RA at greenlight.guru. WHO Monkeypox Prevention Recommendation Met as Discriminatory, Stigmatizing. Why do we need a new rule about intended use? Ask yourself, what is your risk appetite? 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. Important Safety Information . Recently, I had a, , president of Vascular Sciences (who will speak on the topic of designing device labeling at the upcoming. Entered by: PLR TRADUZIO (X) 16:22 Oct 27, 2013. Under what conditions will the product be used? This statement covers all three requirements and very clearly indicates where, when and how the device is to be used. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. Theres another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. Indications for oxygen concentrator use Your doctor could recommend the use of an oxygen concentrator for many different conditions, both chronic and acute. It states: Please refer below FDAs definition of indented use & indication for use. Intended use = what you say on the label that the device is to be used for. Instead, it should lay out the claims of what your device is meant to do. Simply scroll down the page, and you'll . How is this medical device classifed? is one of the first items you need to figure out as part of your regulatory strategy. Everything you do will affect product classification, and this should be an early consideration, along with reimbursements. 1.67K views September 24, 2020 FDA. Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat). FDA wants you to be very "to the point" about your stated intended use on your 510(k) submissions. 21. The "intended use" of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. Note: Proposed New Rule relating to Intended Use has been issued by FDA (23 September 2020). 3. 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. Ideally, you want to somehow strike a balance that satisfies them all. The intended purpose statement must be unambiguous and include only those indications for which a positive benefit-risk conclusion can be demonstrated. Hear his presentation on why design inputs go wrong at MD&M East in New York City on June 14, 2017. 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. 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. hb```K,s@( 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. Do you try to hit a homerun with nobody on base? Corallo will speak at the session titled, "Intended Use vs. 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. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not be using your device. Sometimes, "Indications for Use" are not even considered! 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? Overview of Intended Use. Codes for reimbursements work on a strict system and can lead to all sorts of regulatory headaches. Intended use vs. indications for use. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes. 0. "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. Intended Use Statement. The medical device industry is chock full of terminology and acronyms that are important to know and understand. http://medicaldeviceschool.com/A00002.html.check, http://medicaldeviceschool.com/index.html, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf. Different Indications for Use in Different Countries -- how to handle IFU? Understand that intended use and indications for use have an impact on design controls and quality measures. Indications. 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. All physicians are paid consultants of Shockwave Medical. Each statement might have a different affect on design controls, risk management, and quality requirements. Each statement might have a different affect on. 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. 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. 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. The FDA defines intended use as, "the objective of the persons legally responsible for the labeling of devices". How is this medical device classifed? is one of the first items you need to figure out as part of your regulatory strategy. No one wants to get their terms in a tangle and put the timeliness of a product release and regulatory compliance at risk. 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. 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. (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%). on June 14, 2017), about this topic, and we discussed advice for engineers dealing with it. 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. (Response) FDA disagrees with these comments. 1 Technological advances over the past decade have led to a shift in PAD treatment modality such that most patients are now managed endovascularly. Should a CT scanner specify every disease condition for which it might be used as an aid to diagnosis? Use of the Technical Information for any other purpose other than Intended Purpose is prohibited.. . By comparing your device's intended use, indications for use, and technological characteristics with approved products, you can determine the classification. How much, or how little, you need to take care of can be determined by that label. Why do we see so many similar products out there on the market? It describes what your product does. The IntelliHab system is intended for strengthening of the muscles byapplication of neuromuscular electrical stimulation (NMES) therapy. One reason is the me too strategy. 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. *%J#* 2d~z>mU{jWd [{D8oOC$}wd^S7%y ]3 \u5}foFBIyG~L9\O*xnBz 'g~4iqP;0vw' What are the nuances of the wording and how will the wording be interpreted? 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. al devices, lets face it, its hard getting something brand new out there. Indications of use = the conditions or reasons for using the device. These generally are simple statements of no more than 2-3 sentences that outline the device's tools specific use within a particular market. It should be distinguished from intended purpose/intended use, which describes the effect of a device. 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. 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. Rather, define exactly what it is in as few words as possible. 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. Honestly, one of the easiest paths to get a product to market quickly is to copy a previously cleared 510(k). Now, anyone who has dealt with. undefined launched on , while undefined debuted on . Each statement might have a different affect on design controls, risk management, and quality requirements. The original 1938 act was amended in 1976 to include medical devices, and almost fifty years later remains the pivotal . The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. FDA wants you to be very to the point about your stated intended use on your. 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. Contraindications Indications for Use. 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. So, what are the intended uses and indications of NPWT? 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. 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. Put in simpler terms, the intended use is what the purpose of your device is. medical devices with an intended purpose of disinfection or sterilisation of devices). The IFS washers, provided non-sterile, are intended to prevent a screw head from Another consideration is medical reimbursements. MD+DI Online is part of the Informa Markets Division of Informa PLC. Theres another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. The intended use statement refers to the objective intent or purpose for your device, as evidenced by your labeling, your claims, and your advertising. This would be like taking that swing for second base. Jon Speer is cofounder and vice president of QA/RA atgreenlight.guru. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of . The medical device industry is chock full of terminology and acronyms that are important to know and understand. 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. endstream endobj startxref It is not what your device is designed to be used for or even what it could be used for. These devices allow the patient to train specific exercises in order to increase muscle strength and range of motion in different joints. (32.3% vs. 67.7%), so it is difficult to separate the risk of age and gender from each other. 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. Know your terms and know the implications they have on your regulatory requirements. The intended use regulations, including 801.4 . 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. 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. What you say about your product affects what you need to get done and may or may not add to your regulatory burden. Another consideration is medical reimbursements. To what extent should a transcatheter aortic valve replacement specify the grade and severity of aortic stenosis for which it is indicated? Firms: First, intended use is EXACTLY what your product is used for. 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. 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. 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? Understand that intended use and indications for use have an impact on design controls and quality measures. Implied Claimssuch as suggestive product names; statements that imply an "intended use," such as "For best results use approximately 30-45 minutes prior to engaging in sexual intercourse";. Ask yourself, what is your risk appetite? Little words matter is a mantra you should take up when designing your labeling. 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. Intended use = what you say on the label that the device is to be used for. Indication. 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. This would be like taking that swing for second base. 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. Honestly, one of the easiest paths to get a product to market quickly is to copy a previously cleared 510(k). If you should . It was very helpful. Stay up to date with the new Medical Devices/IVD Regulations and innovations in the medical device industry. You have to look at it from liability and reimbursement perspectives. The system is indicated for adult and pediatric use. Find FDA Classification Regulations for Your Device 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. It's not usually a good idea to be that "difficult" company. 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. (b) the basis for the classification of the future planned device into one of the four classes of device, as required by Article 51. 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. Documents on pharmaceutical products are not intended to be used as an alternative to consulting with a health care professional or other qualified professional. hbbd``b`.AD:H0y @$$D H6HHj3012Y 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. So, simply put: Intended use = what you say on the label that the device is to be used for. 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. There is a big difference between writing and designing a submission. Indications for Use. Perhaps reimbursements wont be made unless the labeling says the scalpel should be used on the eye. Intended Use VS Indications For Use. Despite Ruling, PrEP Access Remains Stable But Other Barriers Persist, Driving Diversity, Equity, and Inclusion in Large Medtech Companies. Indications for use cover the reasons or situations in which someone would use the device. What are indications for use for a medical device? Thanks. Its about what your label claimswhat you say your device is meant to do. Hear his presentation on why design inputs go wrong at MD&M East in New York City on June 14, 2017. Intended use vs. indications for use Intended use means the general purpose of the device or its function. 963 0 obj <> endobj Its purpose is not to describe what the device is intended to be used for. 1 is one of the first items you need to figure out as part of your regulatory strategy. Thanks for that article. It's about what your label claims--what you say your device is meant to do. This latter classification leads to a much greater risk to patients, higher regulatory burdenincluding possible clinical trialsand greater expense to get to market. Indications for Drugs (uses), Approved vs. Non-approved. Module 1: Definition and Intended Use of a Medical Device Learning Outcomes At the We have seen many cases in which "Intended Use" and "Indications for Use" have been used interchangeably. The Seattle Seahawks (-4.5) are coming off of a difficult 40-34 overtime loss against the Las Vegas Raiders (-2). Intended Medical Indication Describe the condition (s) and/or disease (s) to be screened, monitored, treated, diagnosed, or prevented by your software. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. We have seen many cases in which "Intended Use" and "Indications for Use" have been used interchangeably. Medical Devices, Medical Information Technology, Medical Software and Health Informatics, 21 CFR Part 820 - US FDA Quality System Regulations (QSR). The views expressed are entirely those of the authors. '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. Perhaps reimbursements won't be made unless the labeling says the scalpel should be used on the eye. "Little words matter" is a mantra you should take up when designing your labeling. There's another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. You might find that other elements are treated with additional scrutiny. 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. Web page addresses and e-mail addresses turn into links automatically. Indications and contraindications Efficacy and safety . Now, anyone who has dealt with classifications of medical deviceswill realize what a big deal this could be. 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 . Copyright 2022. Considerations might include who your team members are --any power hitters? Why do we see so many similar products out there on the market? However, without a definition of the indications for lumbar fusion, it is extremely difficult to demonstrate a satisfactory benefit-risk conclusion. Also keep in mind there can be differences between intended use and indications for use depending on which regulatory market you are speaking about. 0. For a better experience, please enable JavaScript in your browser before proceeding. Why do we see so many similar products out there on the market? There will be vast differences in terms of the burden placed on you depending on the classification. One Medical Device, two indications, two classes, one technical file? It certainly affects your classification. What are the nuances of the wording and how will the wording be interpreted? For example, is it necessary to specify all anatomic locations in which a suture may be used? Intended use vs. indications for use. Or only if you have everyone on base? The most important thing to remember is to apply the same concepts and philosophies in product design to label design and regulatory submissions. 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