"Most every medical device can have some sort of digital layer to it." . With the help of a ready-to-use list of tools, manufacturers will be able to select tools (depending on the intended use or context of use) against which they can compare the . Learn step-by-step how to write your documentation. We use cookies on our website. Non-medical devices. A company that re-sterilizes a single-use device effectively becomes the manufacturer of the device and is responsible for getting it CE or UKCA marked. Good news! 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. Intended Medical Indication 1.1 of the MDR requires a general description of the device that includes the intended purpose. This guidance is issued in accordance with new Section 513(i)(1)(F) of the Act, which was added by Section 206 of the Food and Drug Administration Modernization Act of 1997 (FDAMA). : Provider Comments and suggestions may be submitted at any time for Agency consideration to Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Consideration 1: The lifetime of devices that are intended to be used only for a specific period (i.e. Intended Users of the medical device is the person who is using the device. startups, this shouldnt be applicable. In the CE marking as well as in the FDA pre-market approval or notification, intended use is critical as it helps to decide the classification of a medical device or even for the qualification as a medical device. Instead, this document provides guidance to sponsors by describing the criteria that FDA considers in deciding whether the addition of a specific indication for use alters the intended use of a product that is already marketed with a general indication for use, requiring approval of a PMA. U.S. Department of Health and Human Services : Runtime The purpose of this document is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific indication for use to a medical device cleared for marketing with a general indication for use could trigger the need for a PMA. How is the intended purpose linked to the clinical evaluation? : hubspotutk, __hssrc, test_cookie, lidc, li_gc, lang, lang, bscookie, bcookie, _gcl_au, __hstc, __hssrc, __hssc ,__cf_bm, UserMatchHistory, AnalyticsSyncHistory. : Cookiename Import of research or investigational use in vitro diagnostic device 180.014** Import of a device for non-clinical use/bench testing. Devices determined to be substantially equivalent to a Class III device subject to premarket approval requirements, as well as devices determined to be not substantially equivalent (NSE) to a predicate device, are placed in Class III. The scope of the guidance covers standalone software and applications intended to be marketed in the UK. (S. Rept. Some ideas could be: Qualifications, prior training (for your The MDR (Annex XVI) lists six categories of devices with non-medical use: A determination of "intended use" is fundamental to the U.S. Food and Drug Administration's (FDA) regulation of drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Sometimes the identification of a specific intended use is the result of the evolution of medical practice once a device is marketed. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Intended purpose is defined in Article 2 (12): "'intended purpose' means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;" In the product . 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. Intended Purpose: 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 materials. In general, Regulation (EU) 2017/745 will apply to these product groups starting from 22 June 2023. This is a novelty introduced by the MDR, as Annex XVI contains a list of devices without an intended medical purpose, which are nonetheless covered by the regulation. How the intended use of the medical device can be decided that has both the medical device and medicinal effect so that it can regulated under the MDR or MDD? Describe the typical user of the software. It receives input from the user and outputs information. be considered a use already cleared under a current 510(k)? Level of specificity: The change from a general use (evaluating soft tissue) to a specific recommendation to biopsy or not to biopsy is a significant change. your software. Rather, these criteria should be seen as important contributing factors, which, when used appropriately, can help the agency consistently arrive at reasonable regulatory decisions that relate to the safety and effectiveness of medical devices. Intended use = what you say on the label that the device is to be used for. what it's used for and how to use it). Risk: The risks related to ablation of the entire endometrial lining as well as a portion of the myometrium under ultrasound guidance are far greater than ablating isolated lesions of the cervix and other, more circumscribed, gynecologic abnormalities. Risks: The safety and effectiveness of the device are related to size, shape, flexibility, and biocompatibility for both sets of indications. Article 7 of the MDR prohibits misleading the user or patient with the devices intended purpose by accrediting functions to the device or creating a false impression regarding treatment or diagnosis, which the device does not have, or not disclosing likely risks, and suggesting uses for the devices other than the uses included in the intended purpose. General indication for use-Quantitative measurement of Factor VII in patients with known or suspected Factor VII deficiency (identifying or assessing a group of people with a rare genetic disorder), Specific indication for use- Factor VII assay as a predictive marker for stroke (using the same test on a significant number of asymptomatic adults at risk for stroke). a statement that includes the information about the intended patient population, medical conditions, indications, and contraindications. The characteristics of the device and its intended purpose are the basis on which a manufacturer justifies the level of clinical evidence that is required. View our articles and questions about getting software certified. 1 We'll assume you're ok with this, but you can opt-out if you wish. The total number of Devices classified are 32. active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device; Put in simpler terms, the intended use is what the purpose of your device is. 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). In order to be categorized as a medical device " it shall not achieve its principal intended action by pharmacological, immunological or metabolic means, but may be assisted in its function by such means." For the purpose of this guidance, the definitions for "general to specific" and "level of specificity" listed below are used. any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized examples diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular It states what your software does and in which context it is used. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, General/Specific Intended Use - Guidance for Industry, Identification or measurement of a physical parameter (e.g., image, heart rate) or biochemical parameter (e.g., analyte), Identification of a new or specific target population (e.g., women, children of a certain age range) or anatomical location (e.g., MR of the brain), Identification of the clinical use of the measurement (e.g., diagnosis, screening), Identification of or implication of an effect on the clinical outcome (e.g.,screening mammography reduces breast cancer mortality), Identification of tissue type (e.g., soft tissues), Identification of an organ system (e.g., GI tract ) or, Identification of a particular disease entity (e.g., resection of hepatic metastases) or target population, Identification of an effect on clinical outcome (e.g., use of medical device improves the rate of durable complete remissions with chemotherapy). General indication for use- Ablation of soft tissue in urology, Specific indication for use- Treatment of prostate cancer. regulations. It would, therefore, constitute a minimum change in levels of specificity, as defined above. Statistic cookies anonymize your data and use it. In addition, a 510(k) is required when a legally marketed device is to be significantly modified in design, components, method of manufacture, or intended use ( 21 CFR 807.81(a)(3) ). Hence indication of use also affects the classification of the medical device. The authorised use, including the intended use, but also other planned actions of the user with this medical device such as storage, transport, update or cleaning. 801.20 - 801.57. group, weight range, health, condition(s). For example, if an implant is applied on a patient by the Healthcare professional who is applying this device is the intended user of the device. General indication for use- Ablation of tissue in gynecology, Specific indication for use- Endometrial ablation (with ultrasound guidance). Even though documents such as labels, instructions for use as well as promotional materials will be created at a later point in time, these documents and the promotional strategy should be considered when defining the intended purpose. When determining the intended purpose, consider to explicitly mention any limitations (i.e. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. But before any of those documents are produced, the intended purpose is a core part of ones technical documentation, as Annex II. Public health impact- A device intended to predict stroke has a far greater public health impact than a device intended to identify a Factor VII deficiency both in terms of the individual and the public at large. : Runtime General exceptions from the requirement for the label of a device to bear a unique device identifier. be using your device. The main aim of post-market surveillance is to ensure that the device, even when marketed, is safe for the intended population. Food and Drug Administration The FDA initiated the Medical Device Development Tools (MDDT) program to facilitate device development and the timely evaluation of medical devices and promote innovation. Food and Drug Administration The device is stand-alone software. (i) by surgical or medical intervention, wholly or partially into the body of a human being; or. The seven top things to consider when writing instructions for use for medical devices are: The intended use. The site is secure. DFE, LST, IRC, LWC, PM#, DDM. Intended use of a medical device defines the purpose for which the device is used. The rule amends FDA's drug and device regulations that describe the types of evidence that FDA will consider when determining whether a product is intended for use as a drug or a device under . Import of device sample for . Form of a unique device identifier. Only relevant if youre aiming for MDD (and not MDR) compliance: And vice-versa, only relevant if youre aiming for MDR (not MDD) compliance: Describe the core medical functionality of your device and how it treats, diagnoses or alleviates a disease. 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. Keeping track of a visitor's identity. 2. Manufacturers have to plan, to continuously conduct (more about post-market surveillance here), and document a clinical evaluation for their device if used, as intended, to conform to the general safety and performance requirements set out in Annex I of the MDR. This question will not be directly addressed in this document. Check whether the anticipated device fulfils the definition of a medical device in Article 2 (1). New versions of these devices were presented to the agency to be cleared for use in "suction lipectomy" for body contouring. This website uses cookies to improve your experience. Please dont remove this notice even if youve modified contents of this template. The removal of large quantities of body fat raised questions of safety and effectiveness not posed by the labeling of pre-Amendments aspirators, e.g., possible metabolic changes, and permanent bagging of the skin resulting when the fat removed from the area exceed the ability of the skin to contract. The FDA defines intended use as, "the objective of the persons legally responsible for the labeling of devices". This surgical outcome, which would affect large numbers of "well" patients desiring enhanced body image, had never been validated through controlled clinical trials. Read about the three mistakes other startups make and how you can succeed with us. '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. If it does, decide the classification in accordance with Article 51 and the rules contained in Annex VIII. Purpose. A change from a general to a specific indication for use is defined as: Any proposed increase in the level of specificity of the indication for use of a medical device. Runtime While these guidance documents provide information relevant to FDAs decision-making processes with respect to general/specific use, Congress indicated through FDAMA 206 that FDA should provide additional guidance on the approach that the agency takes when evaluating whether a new indication for use, which appears to fall within the scope of the intended use of a legally marketed predicate device, is a new intended use that would require a PMA. What is the intended purpose of a medical device? Item #4 of the 510(k) flowchart (K86-3), which FDA reviewers have used for years in 510(k) evaluations, asks "Do the differences [ in indications ] alter the intended therapeutic/diagnostic effect" and directs FDA reviewers to "consider impact on safety and effectiveness ." Intended Use (check out alsoGHTF/SG1/N70:2011) is an objective aim of medical products manufacturers related to the purpose of the products, processes or service. Why? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print. The intended users may be a trained or the untrained user. 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 require a premarket . One of the "hidden" medical devices in the school setting is the baclofen pump, which is used for the treatment of spasticity. Public health impact: Women with abnormal uterine bleeding constitute a large group, estimated in the hundreds of thousands. It represents the Agency's current thinking on the above. This change creates risks not associated with the general indication for use. The total accumulated F0 for of 121C and a z-value of 10C is determined by the following equation: Where: t1 = start time; t2 = end time; T = temperature Adding up the instantaneous lethality time and temperature contributions over the entire sterilization process will provide the F0 for the autoclave's sterilization process. Template Copyright openregulatory.com. The goals of spasticity treatment are to decrease muscle tone, deformi. hardware devices. following more than five years of revisions and delays, the u.s. food and drug administration ("fda") published its final "intended use" rule (the "final rule") and amended its regulations describing the types of evidence that the agency will consider in determining whether a company intended to market a prescription drug or medical device for a 4Please refer to Levels of Specificity section under Definitions. Describe the typical use environment. The intended purpose should be developed together with two other statements that are part of the technical documentation: The intended purpose describes the intended medical usenot the specific product features or specifications of an anticipated productand has to be formulated in a clear, precise, and unambiguous way. software), technical proficiency, time spent using the software. Unless reclassified into Class I or Class II, these devices cannot go to market without an approved PMA or a completed product development protocol. It is important to know that under MDR, there is a clear link between intended purpose and the clinical evaluation, which is not only mentioned in Article 2(12) but also in Article 61(1): The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. You could conceivably write on a chalkboard horizontally an array of intended uses: anesthesiology, cardiology, clinical chemistry, dental, gastroenterology, ophthalmology, obstetrics, radiology and the list goes on. ( a) to be introduced, either . Hows the lighting? 124: Surgical Dressings: Fixation, non-absorbable for pelvic use. While the US FDA uses the term "intended use", "intended purpose" and "intended use" are often used synonymously in the EU, and both terms are mentioned in the MDR. 801.30. Label to bear a unique device identifier. The Agency believes these examples will help illustrate its consideration and application of the criteria and levels of specificity described above in this memorandum. Join our upcoming free consulting call and get answers to your questions! Tired of copy-pasting? 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. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. The level of specificity is defined as: a qualitative ranking of the proposed indications for use of a medical device. General indication for use- Provide access to vasculature for diagnosis/therapy, Specific indication for use- Provide access to neurovasculature for diagnosis/therapy. Here's the short answer; the FDA (section 6.3 of the FDA Guidance on General Principles of Software Validation) states that "off-the-shelf software development tools, such as software compilers, linkers, editors, and operating systems" are required to have intended use validation performed. How did other companies like working with them? Cryosurgery in gynecology. Thus, the purpose of this guidance is to describe that decision-making process and its basis in the law and in agency practice. Those factors vary from device to device and also may change over time with respect to a particular device. The following templates are Documents or SOPs related to this template. FDA's long . 801.4 (devices) and 201.128 (drugs), determines whether a medical device or drug is being marketing for a use that exceeds its clearance or approval (i.e., an "off-label" use). Why Your Intended Use Is Important Why is that so important? In such cases, regulatory issues not addressed in this document may apply, 3 A second related issue is, when would a specific intended use that falls within a general use not require a submission of any kind, i.e. and the information on the principles of the operation of the device and its mode of action, scientifically demonstrated, if necessary. : https://policies.google.com/privacy?hl=en&fg=1. : Host DI. In this instance, FDA determined that this was a new intended use requiring submission of a PMA. Risk: The risk of false negative studies leading to postponement of breast biopsy is far greater than the risk of false negatives in general ultrasound studies. . Imprint, Die IEC 60601-1:2013 defines the "usage in accordance to regulations" as, Virtual Manufacturing / Own-brand Labeling, Human Factors / Usability (IEC 62366 and FDA). Necessary cookies are absolutely essential for the website to function properly. In some cases, technology may drive a manufacturers decision to request the addition of a specific indication for use; "minor" technological changes to a device may make it more applicable to one specific indication for use and less applicable to other uses. Intended use: indications for use, including the disease or condition the device will diagnose, treat, prevent, cure or mitigate the severity and stage of disease patient population (age, gender, anatomy, physiology, other aspects) the site of application to/in the body (organs, parts of the body, tissues or body fluids contacted by the device) Host Rockville, MD 20852. If the device is not CE or UKCA. It is an important process through which one can increase the benefit-risk ratio. The purpose of this document is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific indication for use to a medical . Does the MDR cover devices without an intended medical purpose? You can download it as Word (.docx), PDF, Google Docs or Markdown file. We get stuff done really fast. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. user profile (section below), but not necessarily. A second example, cited in Blue Book Memorandum #K86-3, relates to powered suction-aspiration devices, which were initially cleared to remove tissue and fluid from the body during surgery. Updated October 20, 2022 Writing An Intended Use for Software as a Medical Device Dr. Oliver Eidel The Intended Use is the most important document, ever, if you want to certify your software as a medical device. Repair of medical device and re-exportation. : Privacy source url There are multiple factors that influence those determinations. Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements. Those devices are similar to medical devices in terms of functioning and risk profile, even though the manufacturers only claim non-medical purposes (for example, aesthetic ones). See template license. One of the conditions for benefiting from the transitional provisions is that the legacy device does not undergo "significant changes in design or intended use ". In these Regulations, unless the context otherwise requires . The agency believes it could not formulate such a rule without compromising the ability of FDA reviewers to factor in the important public health and regulatory considerations that are essential to making appropriate classification determinations. Its kind of a stretch to describe the operating principle of software. The term intended use includes medical devices, strictly speaking in two aspects: The actual medical purpose, that is, which disease or injury you can diagnose, treat or monitor The authorised use, including the intended use, but also other planned actions of the user with this medical device such as storage, transport, update or cleaning. General indication for use- identify known or suspected peptic ulcer patients with H. pylori, Specific indication for use- identify known or suspected pediatric peptic ulcer patients with H. Pylori. Some ideas for characteristics to describe: Age catheters to deploy a stent) is defined based on their use duration. This was a situation where an overriding potential public health benefit, an established safety profile, and an identical mechanism of action were weighed against concerns regarding the level of available effectiveness data in deciding that 510(k) was the appropriate regulatory pathway for this indication for use. These information will help us to learn, how the users are using our website. It is important to highlight that the intended use has to be consistent throughout the entire technical documentation and in all future documents on the device. It is passed to HubSpot on form submission and used when deduplicating contacts. Nor should the list be viewed as a scale which can be used to calculate a particular outcome. This guidance also indicates that some modifications in indications will be considered a new use, "even though the intended effect of the new device is very similar to that of the predicate device." All written comments should be identified with this document's docket number: FDA-2020-D-0957. How to determine if your product requires medical device CE marking. 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 require a premarket submission. These cookies are needed to let the basic page functionallity work correctly. 3 Borderline products, drug-delivery . have a smartphone with a compatible operating system (iOS / Android). 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? The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) Jon Speer. These criteria should be evaluated in connection with the Levels of Specificity4described earlier in this document. The criteria that follow are provided as guidance on the Agencys decision-making process for determining substantial equivalence or non-equivalence for general/specific uses. 180.010. The intended purpose should, therefore, be formulated by a medical, regulatory or quality professional (providing the crucial understanding of the regulatory and clinical consequences) and for the intended user group (either medical professional or patients) in the appropriate medical language. Once you have the ingredient GRAS for use in conventional foods, the ingredient is placed in the food supply. This category only includes cookies that ensures basic functionalities and security features of the website. The definition mentions documents such as label, instructions for use, and promotional or sales materials as well as the clinical evaluation. Tracking and analys of traffic on our websites. Intended Use and Indications of Use of Medical Device. The Senate committee report which preceded the final FDAMA bill stated that "this clarification [with respect to general/specific use] is important because FDA has not established a consistent pattern upon which persons who submit premarket notifications may rely." The device is stand-alone software. Content for Videoplatforms und Social Media Platforms will be disabled automaticly. Knowledge base: As opposed to other gynecologic applications of cryosurgery, which are widely reported in current published literature, the scant supporting literature for this indication for use dates back 2-3 decades and reports preliminary investigations or is anecdotal in nature. out, e.g. Just document the intended use of your device and check if it falls under the medical device definition. 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.". The Court's reasoning however is interesting and of course, it's the . Medical indication (for example, illness), Intended use environment / usage environment. (b) the basis for the classification of the future planned device into one of the four classes of device, as required by Article 51. These requirements are specific for non-device or non-product tools - most commonly software. UDI. 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. First, intended use is EXACTLY what your product is used for. Intended use: Medical Device Manufacturers must designate all the potential applications of a medical device (i.e. When should the intended purpose be defined and by whom? : Provider 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). Class C They're often . whether or not a product is a medical device, the classification rules could lead to a different risk class, conformity assessment route for the device, a medical, regulatory or quality professional, Swiss authorised representatives for medical device manufacturers, How to obtain a CE mark for a medical device, Is my product a medical device in Europe? Those indications for use for which a considerable body of knowledge or experience exists to demonstrate that the specific use falls within accepted parameters for the general use of the device, as defined by the clinical community (see below, example 7). : Cookiename This document supersedes Determination of Intended Use for 510 (k) Devices; Guidance for Industry and CDRH Staff issued January 30, 1998 U.S. Department of Health and Human Services Food and. One of the challenges in risk analysis of medical devices is the diversity of use scenarios based on the target medical purpose and use environments. with our social media, advertising and analytics partners. Office of Device Evaluation. The intended purpose of a device should be defined early in the medical device development process, as it is the basis for various significant decisions, and the wording will influence the subsequent steps. Knowledge base- The new indication for use is not well-described in the published literature, and clinical information from other sources are not available. 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. Alternatively, a new competing device may enter the market with a specific claim resulting in a potential loss of market share for the device without that claim. In this post, we will discuss the intended purpose of medical devices with reference to the regulatory framework of the European Medical Device Regulation (EU) 2017/745. IFE. MDR allows one to use clinical data sourced from clinical investigations, other studies, and reports published in peer-reviewed scientific literature on a device for which equivalence to the device in question can be demonstrated. The first example, cited in the same 1997 Senate report, relates to a substantial equivalence determination made for condoms, using the general indication for use of prevention of sexually transmitted disease as a predicate for condoms labeled to prevent the transmission of HIV. If the goal is to add the ingredient to conventional foods, the GRAS pathway is best. The list of criteria should not be considered to be all-inclusive. A Unique Device Identification (UDI) system is intended to provide a harmonized system for the positive identification of medical devices throughout their distribution and use. Methods used to assess other laser applications do not apply. Conversely, when does a specific indication for use become a new intended use that requires submission of a PMA to establish the safety and effectiveness of the device? While the US FDA uses the term intended use, intended purpose and intended use are often used synonymously in the EU, and both terms are mentioned in the MDR. In any case, Id just generally state what sort of input goes in and what output comes Describe variants and/or accessories of/to this device, if applicable. 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. The use of essential medical devices such as ventilators, oxygen concentrators, syringes and test kits have contributed to the efforts of pandemic responses around the world, as have other products regulated in some countries such as surgical face masks. Google uses cookies to identify and track users. Scroll down for a preview! 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. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Therapeutic Devices 5. (ii) The . 801.40. 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. The list of examples cited above include some of the relatively few cases that have not been found substantially equivalent in order to illustrate a spectrum of situations where FDA may make a NSE determination. Harmonize the regulatory requirements for medical devices that are intended for a . 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