Embracing the Future: The FDA’s Guidance on AI in Medical Devices
As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good Machine Learning Practice” is a crucial milestone in steering this innovation, ensuring that the benefits of AI are realized alongside necessary safeguards.
Innovation Meets Responsibility
The potential of AI in healthcare is vast. We’re envisioning systems that can analyze medical images with remarkable speed and precision or predictive tools that flag patients at risk before any symptoms emerge. However, with such capabilities comes the need for careful oversight. The FDA’s guidance highlights the importance of solid scientific foundations in the creation of AI-based medical devices.
This guidance is more than a regulatory checklist; it encourages developers to engage in thorough design and rigorous evaluation. It prompts a consideration of the complexities inherent in healthcare environments, urging creators to reflect on how their AI technologies will function in practice and respond to diverse data inputs. The focus on “Good Machine Learning Practice” is a commitment to ensuring transparency, reliability, and accountability in these innovations.
Essential Principles
A central theme of the FDA’s guidance is the necessity for high-quality, diverse datasets. The success of AI tools hinges on the data they are trained with, meaning developers must prioritize representativeness to prevent bias—an increasingly important topic in discussions about ethical AI.
Additionally, the guidance underscores the significance of ongoing monitoring and adaptive learning. In a field where medical knowledge is constantly evolving, the ability of AI systems to update and improve over time is vital. This aspect can revolutionize patient care, allowing devices to learn from new information and enhance their effectiveness.
The Power of Collaboration
What stands out in the FDA’s approach is the emphasis on collaboration among all stakeholders—developers, healthcare professionals, and regulatory agencies. By working together, we can cultivate an environment that encourages innovation while prioritizing patient safety. This teamwork is essential in navigating the complexities associated with AI in medicine, ensuring we maximize the advantages of these technologies while mitigating potential risks.
Looking Forward
The FDA’s guidance on AI is more than a set of rules; it serves as a roadmap for the future of healthcare. As we harness the capabilities of machine learning, we must remain attentive to ethical considerations and patient outcomes.
As we anticipate the integration of AI into routine medical practices, let’s seize this chance to create a future where technology and healthcare collaborate seamlessly. While challenges will arise, a commitment to thoughtful regulation and high standards can help us navigate this exciting landscape together.
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If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we can help you. F2 Labs can provide the evaluation, testing, and label you need to turn the equipment on and turn it over to your customer – and move on to the next project.
When someone says, “UL or CSA Certification” or that your equipment be “UL/CSA Certified” or “UL/CSA Labeled”, that means your product must be evaluated to meet the government guidelines for installation and use of the equipment at that location. In these instances, the AHJ or inspector is asking for you to have your equipment “Field Labeled” by an OSHA approved NRTL (National Recognized Testing Laboratory) and is not asking you to specifically have Underwriters Laboratories (UL) or CSA Group (CSA) perform the evaluation. There are many different labs that can certify products to the UL and CSA standards. You have the freedom to use a different laboratory in almost all cases.
If you have a piece of equipment that is unlabeled and it is preventing you from starting production on your line or turning the equipment over to your customer at their site, F2 Labs can quickly quote and schedule our engineers to get you exactly what you need to get moving. We have three locations in the in the US from which to dispatch our experienced Safety Engineers to perform this testing quickly. Additionally, we collect information from you and review it prior to our visit to reduce inefficient and costly second visits.
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The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic Article Surveillance (EAS), Wireless Power Transfer (WPT), 5G Cellular, electrocautery, MRI, diathermy and electrosurgical devices. The technologies that these devices use are not covered under IEC 60601-1-2.
F2 Labs has developed test methods that are accepted by the FDA to demonstrate medical devices are safe in regard to Common Electromagnetic (EM) Emitters that are foreseeable in the intended use environment, and in some areas where you may not even realize that these technologies are present.
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F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device.
From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views as ‘essential performance’, does not align with the definition of ‘Essential Performance’ from IEC 60601-1.
They consider every function described by the product’s specification to be ‘essential’. If the device does not work as intended – what is the point? Who would want to buy or use it? These specifications will need to be proven through bench testing typically performed by the manufacturer, on the manufacturer’s behalf by an accredited laboratory. However – this is not the same as what 60601-1 intends when it defines Essential Performance.
For the purposes of 60601 testing, the definition Essential Performance is this:
Essential Performance: those clinical functions which ‘if degraded or not present, could result in an unacceptable risk’.
Blending the two ideas of essential performance together muddies the waters, and often creates confusion in developing the correct Essential Performance for a device.
Defining Essential Performance can be simplified by breaking it down into manageable pieces as follows:
1. Create a list of your device’s clinical functions (there could be one, none, or many). 2. Review each one individually and ask “If this function is not performing correctly (inaccurately or at all), could it result in an unacceptable risk?”
(a) If the answer is no, that particular function is notEssential Performance. (b) If the answer is yes, that particular function is Essential Performance.
3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring.
That’s it – you could end up with one, none, or many. The rationale you use for making these decisions should be detailed in your Risk Management File.
Let’s follow the above steps using the simple example of a basic thermometer.
1. List of clinical functions:
(i) Measure temperature accurately. (ii) Display that measurement on a cell phone app.
2. Review each clinical function individually, and ask the question – is this Essential Performance?
(i) Measure temperature accurately:
Yes – treatment decisions will be made based on this measurement (i.e. administer medication)
(ii) Display that measurement on a cell phone app:
No – if the result is ‘unavailable’, a different thermometer could be used, no treatment decisions would be made, etc.
3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring it.
(i) Measure temperature accurately.
(a) Define the exact requirement(s): measure temperature within +/- 0.10 degrees (b) Define the method of monitoring/measuring: use a calibrated thermometer or calibrated water bath to verify the measurement accuracy.
In this example, the Essential Performance and Method of Monitoring for this thermometer is:
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What exactly is the environmentally conscious design file? You need documentation/policies that show how you are addressing the requirements of that standard. You really should use the standard as guidance (IEC 60601-1-9). Here is some good information on what this standard covers. Note – you must have documentation – but it does not have to be fancy or complicated, it can be ‘simple’.
IEC 60601-1-9 addresses the environmental aspects of medical electrical equipment. Its primary purpose is to guide manufacturers in designing medical devices that are environmentally conscious throughout their lifecycle.
Key Purposes of IEC 60601-1-9:
Environmental Impact Reduction:
It focuses on reducing the environmental impact of medical devices, including energy consumption, resource use, and waste production, during the design, manufacturing, usage, and end-of-life phases.
Life-Cycle Assessment:
The standard encourages the consideration of the entire life cycle of the product, from raw material extraction to disposal, ensuring that environmental impacts are minimized at each stage.
Sustainability:
It promotes the use of materials and processes that are less harmful to the environment, such as reducing hazardous substances and increasing the recyclability of the equipment.
Compliance and Certification:
Compliance with IEC 60601-1-9 can be necessary for regulatory approvals in certain markets, and it demonstrates a commitment to sustainable practices in medical device manufacturing.
Is this a mandatory requirement? This is a mandatory requirement coming from Brazil.
For the RMF, can we substitute it with our existing risk management file? Yes, these are the same thing.
Summary:
IEC 60601-1-9 is intended to ensure that medical electrical equipment is designed with environmental considerations in mind, promoting sustainability and reducing the ecological footprint of these devices.
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As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing, lucrative growth opportunity. Entry into this market comes with its prerequisites, however, one of which is CE certification. This certification is a regulatory mark that signifies a product’s compliance with EU legislation, primarily focusing on health, EMC, safety, and environmental protection. Products ranging from electrical equipment to toys to medical devices all require CE certification to be sold within the European market.
CE certification is more than just a sticker on your product; it’s a passport for your products’ arrival into the European Union. It applies to a broad range of goods, including consumer electronics, machinery, and medical devices. CE certification upholds basic principles of health, safety, and environmental protection, ensuring that products sold within the EU do not compromise the well-being of its users or the environment.
Understanding the CE marking process and ensuring compliance is pivotal for manufacturers aiming for market entry, as it not only facilitates smoother customs clearance but also boosts consumer confidence in product safety and standards.
The CE Certification Process: A Step-by-Step Guide
Navigating the CE certification process requires meticulous attention to detail and a thorough understanding of the European Union’s regulatory environment. Before a product can proudly display the CE mark, manufacturers must embark on a multi-faceted journey that begins with identifying the specific legal frameworks applicable to their product. This initial stage lays the groundwork for the entire certification process, underscoring the necessity for precision and expertise in regulatory compliance.
1. Identifying Relevant EU Directives and Standards: The first step in obtaining CE certification is to identify which specific EU directives and harmonized standards apply to your product. This involves a detailed analysis of your product’s features and functionalities to match them with the relevant legal requirements.
2. Assessing Product Compliance: Once the applicable directives are identified, manufacturers must assess whether their product complies with these requirements. This can be done through self-assessment or by engaging third-party CE certification services, which can provide an unbiased evaluation of your product’s conformity.
3. Technical Documentation: Compiling comprehensive technical documentation is a critical step in the CE certification process. This documentation should provide evidence of compliance with the relevant directives and standards, including design, manufacture, and operation details. It serves as a dossier that demonstrates your product’s eligibility for the CE mark.
4. CE Marking and Declaration of Conformity: After ensuring compliance and compiling the necessary documentation, manufacturers can then affix the CE mark on their products. Alongside this, a Declaration of Conformity must be drafted, declaring that the product meets all the relevant requirements. This declaration must be available to the European authorities upon request.
Challenges and Solutions in Obtaining CE Certification
Manufacturers often face challenges such as navigating the complex landscape of EU directives, ensuring accurate product classification, and managing the comprehensive documentation required for compliance. A practical solution is to leverage the expertise of CE certification services, which can guide you through the intricacies of the process, from initial assessment to the final declaration. Engaging with these services early in the product development phase can mitigate risks and streamline the path to compliance.
CE certification is a crucial milestone for manufacturers aiming to enter the European market. It not only ensures that products adhere to high safety, EMC, health, and environmental standards but also opens the door to a vast and diverse marketplace. By integrating compliance into the early stages of product development and utilizing the expertise of CE certification services, manufacturers can navigate the certification process more efficiently, avoiding common pitfalls and accelerating market entry.
Let F2 Labs be your guide to success in the European market, ensuring that your products are welcomed by consumers and regulators alike.
Reese’s Law was signed by President Biden on August 16, 2022 and as of March 19, 2024 all products that incorporate button batteries or coin cell batteries must comply with UL 4200A as the safety standard for performance and labeling per 16 CFR 1263. The intent of this law is to reduce the risk of injury from the ingestion of button cell or coin cell batteries by children six years or younger.
Per UL 4200A products that contain these battery types or are designed to use these battery types must:
Have compartments that hold such batteries be secured such that they require a tool or at least two independent hand movements to open
These compartments cannot be accessed or the batteries contained therein accessed as a result of repeated use and abuse
The packaging must contain a warning label
The product itself must contain a warning label
Manuals and instructions must include all applicable warnings.
F2 Labs can assist in the required testing necessary to comply with Reese’s Law. Reach out to us today to begin a discussion with one of our technical sales staff to guide you through the process.
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The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2 Labs performed a deep dive into the two EU regulations to figure out what is new, what is staying, and what has been removed.
Not much has changed, but it is different. The major new thing is that Annex IV from 2006/42/EC has been split into two categories in (EU)2023/1230 – Annex I, Part A and Part B. Part A has stricter requirements than Part B. Part A requires a compliance procedure from Article 25(2.) while Part B requires a compliance procedure from Article 25(3.) Keep in mind – most machinery does not fall into Annex I. Machinery that does not match the equipment in the Annex I list requires a compliance procedure from Article 25(4.).
Let’s break these compliance procedures down for each of the three scenarios.
Annex I, Part A covers –
Removable mechanical transmission devices. including their guards.
Guards for removable mechanical transmission devices.
Vehicle servicing lifts.
Portable cartridge-operated fixing and other impact machinery.
Safety components with fully or partially self-evolving behavior using machine learning approaches ensuring safety functions.
Machinery that has embedded systems with fully or partially self-evolving behavior using machine learning approaches ensuring safety functions that have not been placed independently on the market, with respect only to those systems.
Annex I, Part A equipment can use these compliance modules:
Internal Production Control + Conformity to Type (EU type-examination)
Conformity based on Full Quality Assurance
Conformity based on Unit Verification
Annex I, Part B covers –
Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics of the following types: 1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed; 1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage; 1.3. sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading; 1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
Hand-fed surface planing machinery for woodworking.
Thicknesses for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types: 4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece; 4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
Hand-fed tenoning machinery with several tool holders for woodworking.
Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
Portable chainsaws for woodworking.
Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
Injection or compression plastics-moulding machinery with manual loading or unloading.
Injection or compression rubber-moulding machinery with manual loading or unloading.
Machinery for underground working of the following types: 12.1. locomotives and brake-vans; 12.2. hydraulic-powered roof supports.
Manually loaded trucks for household refuse collection, incorporating a compression mechanism.
Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 m.
Protective devices designed to detect the presence of persons.
Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this Part.
Logic units to ensure safety functions.
Roll-over protective structures (ROPS).
Falling-object protective structures (FOPS).
Annex I, Part A equipment can use these compliance modules:
Internal Production Control
Internal Production Control + Conformity to Type (EU type-examination)
Conformity based on Full Quality Assurance
Conformity based on Unit Verification
Equipment that is in scope of the Machinery Regulation but does not match any of the equipment listed in Annex I is only able to use Internal Production Control (Module A) as the compliance module. This means there is no legal reason to involve a Notified Body in your Machinery Regulation evaluation unless your equipment is listed in Annex I. Even then you can possibly avoid it. This is the same policy as in the current Machinery Directive.
What are each of these compliance modules and what do they mean?
Internal Production Control, Module A – this means you have the equipment tested by an accredited lab using applicable harmonized standards, compile all documentation that validates compliance (your Technical File with all reports, critical component data sheets, manuals, drawings, schematics, etc), draft an EU declaration of conformity, mark the equipment with a CE marking, and then sell as many as you can to customers in the EU.
Interestingly – Internal Production Control is allowed for all Annex IV (under the current Machinery Directive 2006/42/EC) equipment as long as all applicable to MD Annex I EHSR’s (essential health and safety requirements) are validated by checking against harmonized standards. The new Machinery Regulation (EU)2023/1230 split Annex IV from 2006/42/EC and made it into two sections: Annex I, Part A and Part B in the new regulation. Part A requires Notified Body involvement no matter what. Part B equipment can be made compliant by following Module A only if harmonized standards under the Machinery Regulation that address each risk matching an EHSR from Annex II of that regulation. That means you can, possibly, comply with the Machinery Regulation without contracting with a Notified Body.
EU Type-Examination, Module B – this means you have the above evaluation (Internal Production Control, Module A) performed by an accredited test lab and send the documentation (Technical File including EU declaration of conformity) along with a sample of the product to an EU Notified Body that is authorized to issue a certificate for your product category. That can be a little tricky for a few reasons – one: you probably want one that speaks English and two: you cannot change Notified Bodies once you start, so if your product does not pass the EU type-examination you will not be able to go to another Notified Body. You will need to work with the original Notified Body that gave you the failing report and resolve the identified issues, if there are any. Note that you are not finished with an EU type-examination. That is a Notified Body checking that the product was tested to the appropriate standards and the resultant evaluation and test data is valid. In other words, it is a part of a process you may need to follow.
Conformity to Type Based on Internal Production Control, Module C – this is Internal Production Control (Module A) + EU type-Examination of your product (Module B). So, this module is A + B = Module C. This is the usual process for Annex IV equipment under the current Machinery Directive 2006/42/EC that we deal with at F2 Labs. Essentially, it means this: You have the product tested by a lab, the resulting documentation is sent to a Notified Body. They approve it and issue the EU type-examination certificate. Then it is up to you and your quality system to manufacture each unit identically to the unit that passed the evaluation(s).
Conformity to Type Based on Full Quality Assurance, Module H– this is Internal Production Control (Module A) + EU type-Examination of your product (Module B) + audits of your quality system = Module H. These audits can be unannounced as well and they are performed by a Notified Body.
Conformity Based on Unit Verification, Module G – this involves completing Internal Production Control, Module A, for the product and then releasing the Technical File to a Notified Body – and then the Notified Body conducts the testing on the equipment. This is the most stringent method as it requires a Notified Body to perform the testing, presumably after you have already assured compliance: through testing pre-emptively with an ISO accredited test laboratory. You also must involve a Notified Body for every unit that is destined for the EU.
Other Changes in the Machinery Regulation –
Article 1, 2., (f) in the Machinery Directive 2006/42/EC is moved to Article 1, 2., (p), (i-vi) in the Machinery Regulation (EU)2023/1230. The new regulation also added reference to the Radio Equipment Directive (RED) 2014/53/EU along with the Low Voltage Directive (LVD)2014/35/EU. It addresses the below equipment that can now be excluded from the Machinery Regulation in favor of the LVD or RED. See below –
This Regulation does not apply to:
(p) the following electrical and electronic products, insofar as they fall within the scope of Directive 2014/35/EU or of Directive 2014/53/EU: (i) household appliances intended for domestic use which are not electrically operated furniture; (ii) audio and video equipment; (iii) information technology equipment; (iv) ordinary office machinery, except additive printing machinery for producing three-dimensional products; (v) low-voltage switchgear and control gear; (vi) electric motors;
This is relevant because presently our methodology is to apply the RED to equipment in scope of the Machinery Directive which requires safety testing to the LVD, Anenx I. While the LVD is addressed the same way in the Machinery Directive (Annex I, 1.5.1 Electricity Supply) and the Machinery Regulation (Annex II, 1.5.1 Electricity Supply), the wording is different in the RED.
That brings us to another change. The EU started New Legislative Framework in 2008 that sought to align all Directives and Regulations regarding certain common elements… like the EU declaration of conformity and the Technical File. Since the Machinery Directive 2006/42/EC was written in 2006 it does not align with the “NLF” as it is called.
The requirement for an EU address, which is an EU Contact listed on EU declarations of conformity, is not in the new Machinery Regulation. This requirement is listed in Annex II, 1., A, 2. in the Machinery Directive but is conspicuously absent in the Machinery Regulation.
The last new change we will address in this article is Article 10 in the new Machinery Regulation. Article 11 spells out, in plain English, what your obligations are as manufacturer. It is a short, succinct list of 10 items. It is very easy to read and understand.
More later. We will take this Regulation apart word by word before the 2027 implementation date. Finally, yes, you can claim compliance with both the Machinery Directive and the Machinery Regulation now if your equipment complies with both. No need to wait.
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Today, I read an email from our HazLoc engineering department that I think is extremely useful not only for F2 Labs personnel, but also for our clients who are working on what is required and how to comply. Your first steps in any compliance project will determine the two most important metrics: how much money will it cost and how long will it take?
See the correspondence below and reach out to us with any questions about this or any compliance questions you have.
Since this came up in a meeting today: With US and Canadian Intrinsic safety approvals, we can use several different standards. It’s a bit of an unusual situation and came about because manufacturers pushed back years ago when the new standards came out and did not want to have design their equipment to meet the new requirements.
In Canada, the most current intrinsic safety standard is CSA C22.2 No. 60079-11:2014 (R2023). However, we are still allowed to certify products to the previous intrinsic safety standard CSA C22.2 No. 157-1992. We are able to use CSA 157 through 9-1-2027. Those listings would be able to stay approved to CSA 157 to end of life of the product unless the mfg makes a major change to their equipment after 9-1-2027.
In the USA, the most current version of the intrinsic safety standard is UL913, 8th edition. However, in the USA, we are allowed to use UL913, 5th edition as an alternate (indefinitely, or at least for the foreseeable future). We are also allowed to use UL913, 6th edition if the product is required to be certified to that specific standard. This typically applies to PASS device and other firefighter equipment that is certified to NFPA 1981/1982/1983
The reason why a customer may want to use CSA C22.2 No. 157 and UL913, 5th edition instead of the more current standard is because the requirements in the new standards are more stringent and in some cases will require major re-designs of their equipment. One example is for non-metallic enclosures. The newer standard requires that we assess the enclosure for potential static ignition concerns while the older standards do not. There are a lot of these types of situations between the standards.
1. New Electrostatic Hazard Requirements for Non-Metallic Enclosures and Enclosure Parts.
2. Increased scrutiny for Metallic Enclosures and Enclosure Parts.
3. Increased Safety Factor Requirements for Spark Ignition.
4. Higher level of required conformance for many Protective Components.
5. New requirements for fuses.
6. New enclosure requirements for both Class I and Class II & III.
7. New Drop Test Requirements.
8. New Battery Requirements.
9. New Requirements for Small Components, PC Boards, and Wiring.
10. New requirements for connections (field, internal, and permanently-connected-cables).
11. New PC Board Coatings requirements.
12. Addition of new required testing, both type and routine testing.
13. New requirements for isolating elements (transformers, blocking capacitors, optos).
NOTE: If a customer is also going for an ATEX and/or IECEx approval, then we would always use UL913, 8th edition and CSA 60079-11 since those are harmonized with ATEX/IECEx requirements. The above would only apply for customers that only need US and Canadian approvals.
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The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices that they should always be vigilant in verifying the accuracy of third party testing data that they are using for premarket submissions under 510K, DeNovo, or EUA type approvals. The letter indicates that FDA has seen an uptick in recent years of third-party labs fabricating data, copying test data used in similar submissions, or unreliably characterizing the equipment under use. Although, specific companies are not named, the FDA does point to “numerous such facilities based in China and India.” In cases where this type of data is used, the FDA has no choice but to reject the premarket submission.
F2 Labs is an ASCA (Accreditation Scheme for Conformity Assessment) accredited test laboratory with years of experience in testing and certifying medical devices for use in the United States, Canada, the EU, and elsewhere. F2 Labs stands behind the data that we produce as a result of such an evaluation and has worked hand in hand with the FDA in implementing new testing procedures such as testing for Immunity against EAS, X-Ray Machines, and 5G Cellular devices. Using F2 Labs for your testing effort in preparation for premarket submission should provide confidence in the success of your endeavor. Reach out to us today to begin a discussion with one of our technical sales staff to guide you through the process.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
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You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
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