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sigmabiomedical · 2 months

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Navigating The 510(k) Submission Consulting: Sigma Biomedical An Expert For Medical Device Approval

Are you a medical device manufacturer looking to bring your product to market in the United States? If so, you're likely familiar with the FDA's 510(k) submission process. This crucial step can be complex and time-consuming, but it's essential for ensuring your device meets regulatory requirements. That's where 510(k) submission consulting comes in. In this post, we'll explore the importance of expert guidance and how Sigma Biomedical can help streamline your path to market approval.

Understanding the 510(k) Submission Process

Before diving into the benefits of consulting, let's briefly review what a 510(k) submission entails. The 510(k) premarket notification is a regulatory pathway that demonstrates your medical device is substantially equivalent to a legally marketed predicate device. This process is designed to ensure new devices are safe and effective without undergoing the more rigorous premarket approval (PMA) process.

Key components of a 510(k) submission include:

1. Device description and intended use

2. Substantial equivalence comparison

3. Performance data and testing results

4. Labeling and packaging information

5. Quality system documentation

While this may seem straightforward, the reality is that navigating the 510(k) process can be challenging, especially for companies new to the regulatory landscape or those with innovative devices that push the boundaries of existing classifications.

The Value of 510(k) Submission Consulting

This is where 510(k) submission consulting becomes invaluable. Expert consultants bring a wealth of knowledge and experience to the table, helping you avoid common pitfalls and optimize your submission for success. Here are some key benefits of partnering with a consulting firm like Sigma Biomedical:

1. Regulatory expertise: Consultants stay up-to-date with the latest FDA guidelines and requirements, ensuring your submission meets current standards.

2. Strategic planning: Experienced consultants can help you develop a comprehensive regulatory strategy tailored to your specific device and market goals.

3. Time and cost savings: By streamlining the submission process and reducing the likelihood of delays or rejections, consultants can help you bring your product to market faster and more efficiently.

4. Quality assurance: Consultants can review your documentation and data to ensure it meets FDA expectations, minimizing the risk of deficiencies or requests for additional information.

5. Predicate device selection: Choosing the right predicate device is crucial for a successful 510(k) submission. Consultants can help you identify and justify the most appropriate comparator.

Sigma Biomedical: Your Partner in 510(k) Submission Success

When it comes to 510(k) submission consulting, Sigma Biomedical stands out as a leader in the field. With a team of seasoned regulatory experts and a track record of successful submissions, Sigma Biomedical offers comprehensive support throughout the entire process.

Here's how Sigma Biomedical's 510(k) submission consulting services can benefit your company:

1. Pre-submission strategy: We'll work with you to assess your device's regulatory pathway and develop a tailored strategy for success.

2. Submission preparation: Our team will guide you through document preparation, ensuring all required elements are included and presented effectively.

3. FDA communication: We'll serve as your liaison with the FDA, handling correspondence and addressing any questions or concerns that arise during the review process.

4. Post-submission support: Our assistance doesn't end with submission. We'll provide ongoing support to help you navigate any additional requests or requirements from the FDA.

5. Training and education: We believe in empowering our clients. Sigma Biomedical offers training sessions to help your team better understand the 510(k) process and regulatory landscape.

Maximizing Your Chances of 510(k) Clearance

While 510(k) submission consulting is crucial, there are additional steps you can take to improve your chances of success:

1. Start early: Begin planning your regulatory strategy as early as possible in the product development process.

2. Conduct thorough testing: Ensure your device performance data is comprehensive and well-documented.

3. Stay organized: Maintain clear, well-organized records throughout the development and submission process.

4. Be responsive: If the FDA requests additional information, respond promptly and thoroughly.

5. Consider a pre-submission meeting: This can provide valuable feedback from the FDA before your formal submission.

The Future of 510(k) Submissions

As medical technology continues to advance, the regulatory landscape is evolving to keep pace. Staying informed about upcoming changes and trends in the 510(k) process is essential. This is another area where 510(k) submission consulting can provide significant value, helping you anticipate and prepare for future regulatory requirements.

Conclusion: Partnering for Success

Bringing a new medical device to market is an exciting but challenging endeavor. The 510(k) submission process is a critical step in this journey, and having expert guidance can make all the difference. By partnering with a trusted 510(k) submission consulting firm like Sigma Biomedical, you can navigate the regulatory landscape with confidence, minimize delays, and maximize your chances of success.

Remember, a successful 510(k) submission is not just about clearing a regulatory hurdle – it's about demonstrating the safety and effectiveness of your device to bring innovative healthcare solutions to patients in need. With the right expertise and support, you can achieve this goal efficiently and effectively.

Are you ready to take the next step in your 510(k) submission journey? Contact Sigma Biomedical today to learn how our 510(k) submission consulting services can help bring your medical device to market.

#510(k) submission consulting #510(k) preparation services #medical device 510(k) consulting #regulatory consulting for 510(k)

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i3c-global · 3 months

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FDA 510k Clearance for Medical Device and IVDs

FDA 510k - An Overview

FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III devices in the United States intended for human use must submit a 510(k) if pre-market approval is not required.

Most class 1 devices are exempt from FDA 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number.

We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with file drafting, e-copy conversion, and submission through the US Agent service. Few manufacturers opt for Q submission before final submission.

Role of I3CGlobal Consultants

As a prominent FDA 510k Consultants on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely file preparation for 510(k) clearance irrespective of the manufacturer’s size or the regulatory knowledge of their internal team.

With an impressive 85% success rate, a track record of over 350+ clearances worldwide, and a history of serving more than 150+ manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.

Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete files on behalf of our clients and take full responsibility until the 510k approval is obtained.

DA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

FDA 510k Predicate Device

Substantial Equivalence Definition

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

Get more Information : https://www.i3cglobal.com/fda-510k/

#510k Clearance #FDA 510k Clearance

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amanktreks · 3 months

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FDA 510k Clearance for Medical Device and IVDs

#FDA 510K #Medical Devices #Medical

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workmay · 4 months

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FDA 510k — An Overview

Most class 1 devices are exempt from 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number

Different Types of 510k

Traditional 510k is an original submission that normally has to be provided for the medical device, that requires 510k clearance according to 21 CFR 807. It can also be used to submit if there is any change in the previously cleared device. It generally takes 90 days for the 510k submission.

Abbreviated 510k submission is appropriate when FDA guidance exists for specific medical devices for the demonstration of compliance and any voluntary FDA-recognized consensus standards are available. It covers traditional, as well as a brief report on the usage of FDA guidance documents and FDA-approved standards.

Special 510k submission is for an already cleared device with some changes that don’t require the full review but only the summary document. These changes include indications of use, design, and labelling, but they should not affect the safety or performance of the new, modified device, and well-established methods.

#medicaltools #tools #510k

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myfdalawye · 5 months

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Core Responsibilities of an FDA Attorney: Safeguarding Public Health Through Law

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The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of the products we consume and use every day. From the medications we take to the food on our tables, FDA attorneys are essential members of this process, wielding the power of law to safeguard public health. Their responsibilities encompass a wide range of activities, demanding a unique blend of legal expertise, scientific understanding, and strategic thinking.

Navigating the Labyrinth: Regulatory Compliance

A core responsibility of an FDA attorney is to guide companies through the complex web of regulations that govern the development, manufacturing, marketing, and labeling of FDA-regulated products. This includes:

Understanding Regulations: FDA attorneys possess a deep understanding of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. They stay abreast of constant revisions and new guidance documents to ensure their clients are operating within the legal framework.

Product Review and Labeling: They review product labeling and marketing materials to ensure they comply with FDA requirements. This includes verifying the accuracy of claims, adherence to specific formatting guidelines, and avoiding misleading or deceptive language.

Pre-Market Submissions: For certain products, attorneys assist clients in preparing submissions for FDA approval, such as Investigational New Drug Applications (INDs) for clinical trials of new drugs or Premarket Approval Applications (PMAs) for high-risk medical devices.

Quality Systems Compliance: They advise clients on establishing and maintaining robust quality systems to ensure consistent product quality and adherence to good manufacturing practices (GMPs).

When Disputes Arise: Litigation and Enforcement

FDA attorneys are not just regulatory advisors; they are also skilled litigators who represent the agency or their clients in legal disputes. This encompasses:

Enforcement Actions: The FDA has the authority to take enforcement actions against companies that violate regulations. Attorneys on the government side may be involved in building cases, issuing warning letters, and pursuing civil or criminal penalties. Conversely, private practice FDA attorneys defend companies facing these actions, negotiating settlements and representing them in court.

Product Recalls: When safety issues arise, attorneys play a crucial role in product recalls. They advise clients on the appropriate course of action, ensuring compliance with FDA recall procedures and communicating effectively with the public.

Freedom of Information Act (FOIA) Requests: Attorneys may handle FOIA requests, which allow the public to access certain FDA documents. This requires balancing transparency with protecting confidential commercial information.

Shaping the Future: Policy and Rulemaking

FDA attorneys are also involved in shaping the regulatory landscape through:

Rulemaking: Attorneys participate in the development of new regulations or revisions to existing ones. This involves drafting legally sound and scientifically grounded proposals, considering public comments, and navigating the complex rulemaking process.

Policy Development: They contribute to the development of internal agency policies that guide the interpretation and enforcement of regulations.

Legislative Affairs: FDA attorneys may work with Congress on drafting and advocating for legislation that strengthens FDA's authority and promotes public health goals.

Beyond Legal Expertise: Communication and Collaboration

An effective FDA attorney goes beyond just legal knowledge. Here are some additional crucial skills:

Scientific Understanding: FDA-regulated products often involve complex science. Attorneys need a basic understanding of scientific principles to interpret data, assess risks and benefits, and communicate effectively with scientists and healthcare professionals.

Communication Skills: The ability to translate complex legal and scientific concepts into clear and concise language is essential. Attorneys must effectively communicate with clients, regulatory agencies, the public, and other stakeholders.

Collaboration: FDA regulations often involve multiple agencies and disciplines. Effective collaboration with scientists, regulatory reviewers, and other attorneys is key to achieving successful outcomes.

Problem-Solving and Critical Thinking: FDA attorneys must be adept at problem-solving and critical thinking. They analyze complex situations, identify potential legal and regulatory issues, and develop creative solutions.

The Rewards and Challenges of an FDA Attorney Career

A career as an FDA attorney offers a unique blend of intellectual challenge, professional satisfaction, and the opportunity to make a real difference in public health. However, it also comes with its own set of challenges:

High Pressure: The stakes are high when dealing with products that can impact people's health. FDA Attorney must be able to work effectively under pressure and meet deadlines.

Constant Change: The regulatory landscape is constantly evolving, demanding continuous learning and adaptation.

Work-Life Balance: The demanding nature of the work can sometimes lead to long hours and work-life balance challenges.

Despite these challenges, a career as an FDA attorney offers a rewarding opportunity to combine legal expertise with a passion for public health.

#marketing #alternative

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elexesofficalblog · 9 months

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FDA - Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics.

The advisory committee protects and promotes public health while meeting the requirements established in the Federal Advisory Committee Act.

Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services.

The advisory committee has multiple roles in developing and evaluating New Drugs, Biologics, and Medical Devices.

Their primary goal lies in assisting the FDA to evaluate applications for Pre-Market Approvals (PMAs) of medical devices, New Drug Applications (NDAs), and Product Licensing Agreements (PLAs) for biologics. The committees include chairperson, members, a consumer, industry and sometimes a patient representative.

Medical Devices Advisory Committee

Medical Devices Advisory Committee supports the FDA to protect and promote public health. The committee consists of 18 panels with a maximum of 159 standing members.

The selection of members is carried out by the Commissioner or designee from among authorities in Clinical and Administrative Medicine, Engineering, Biological, and Physical Sciences, etc.

The panel advises the FDA on the safety and efficacy of the medical devices except for the Medical Device Dispute Resolution Panel.

According to the respective specialty area, the panel advises the commissioner of Food and Drugs regarding recommended classification or reclassification of devices into one of three regulatory categories.

For recommendations of medical devices with respect to regulatory aspects, the committee reviews and evaluates the issues related to clinical study designs on the safety and effectiveness of marketed and investigational medical devices.

Overall, the 17 panels except for the Dispute Resolution Panel (DRP) of the medical device advisory committee, advise the Commissioner in accomplishing the constraints in assuring the safety and effectiveness of the medical devices in accordance with their specialty ****area and authorization.

The advisory committee also plays a major supportive role to agency professionals and influence agency decisions. FDA calls meetings with the committee or with the advisory panel as necessary. Generally, each of the panels meet once a year or as per the requirements by the FDA and important regulatory decisions or discussions are carried out in these meetings.

It is important that Manufacturers have a regulatory and quality team that stays abreast of decisions concerning their products and any such decisions or discussions are preemptively taken into account for a speedy FDA clearance, approval or compliance activities.

#medical device #510k #regulatory #cemarking #fda #medical devices

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universalinfo · 11 months

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Unraveling FDA Medical Device Classes and the Value of Medical Device Consultants

In the multifaceted world of healthcare, medical devices stand out as essential tools that aid in the diagnosis, treatment, monitoring, and prevention of various ailments. These devices are incredibly diverse, ranging from everyday items like bandages to highly specialized tools such as robotic surgical systems.

The Food and Drug Administration (FDA) plays a pivotal role in ensuring that medical devices are safe and effective for their intended use. This involves classifying the devices into different categories based on their risk levels. Alongside the FDA’s work, medical device consultants offer their expertise to manufacturers, ensuring compliance with regulations and paving the way for innovations.

In this guide, we’ll delve into the nuances of FDA medical device classes, and explore real-life examples. Also, we’ll discover the crucial role that a medical device consultant plays in this complex ecosystem. Let’s begin, shall we?

The Basics of FDA Medical Device Classes

Medical devices permeate our healthcare system, and their regulation is vital to patient safety. The FDA categorizes these devices into three distinct classes:

Class I

Comprising low-risk devices, Class I includes products that have a minimal chance of causing harm. Examples include bedpans, manual stethoscopes, and examination gloves.

Most Class I devices are exempt from the premarket notification process, and the regulatory controls are relatively relaxed. However, they still must comply with general controls like proper labeling and quality manufacturing processes.

Class II

These moderate-risk devices require more extensive regulatory oversight. Products like powered wheelchairs, infusion pumps, and surgical drapes fall into this category. Manufacturers of Class II devices must adhere to special controls such as performance standards, postmarket surveillance, and patient registries to mitigate risks.

Class III

Class III devices represent the highest risk category and include life-sustaining or life-supporting products. Examples are implantable pacemakers, heart valves, and breast implants. These devices undergo the most rigorous review process, usually requiring a Pre-Market Approval (PMA), which demands clinical trials and extensive data collection to demonstrate safety and effectiveness.

How the FDA Determines Device Classification

Classifying medical devices is a multifaceted process, often requiring the expertise of a medical device consultant. The FDA considers several factors:

Intended use. What is the device supposed to do? What medical conditions does it diagnose or treat?

Risks associated with use. How invasive is the device? What could go wrong, and what are the potential consequences?

Technology and design. How does the device function, and what materials are involved?

Comparison to existing devices. Is it similar to a device already on the market?

A medical device consultant helps manufacturers navigate this complex process, offering insights into regulatory pathways and assisting with necessary documentation and testing.

Real-Life Examples of Medical Device Classes

Real-life examples can shed light on the practical applications of FDA classifications:

Class I: Dental floss, hand-held surgical instruments, elastic bandages. These are common products with well-understood risks, and their regulation focuses mainly on quality manufacturing and accurate labeling.

Class II: Hearing aids, powered wheelchairs, glucose monitors. These devices have more complex functions, and special controls may include clinical trials, postmarket surveillance, or specific guidelines for use.

Class III: Artificial hearts, deep brain stimulation devices, spinal cord stimulators. These are often groundbreaking technologies that may be first-of-their-kind, requiring extensive data and meticulous review.

The Role of a Medical Device Consultant

A medical device consultant is a specialized professional who provides guidance and expertise to medical device manufacturers and other stakeholders in the healthcare industry. They possess in-depth knowledge of the regulatory landscape, quality standards, clinical trials, and market dynamics, ensuring that medical devices meet all requirements from conception to post-market surveillance.

Leveraging their experience and industry insights, medical device consultants play an essential role in navigating the complex world of medical devices. Here’s a closer look at what they do:

Regulatory strategy. They advise on the most appropriate pathway for regulatory approval, whether it’s a 510(k) clearance, Pre-Market Approval (PMA), or a De Novo classification. This involves understanding the device’s classification, risk factors, and corresponding regulations.

Quality management systems. Medical device consultants assist in developing and implementing systems that comply with FDA’s Quality System Regulation (QSR) and international standards like ISO 13485. This helps in ensuring consistent quality and performance of the device.

Clinical trial design and oversight. They collaborate with manufacturers and research institutions in designing and monitoring clinical trials. This includes defining trial protocols, selecting appropriate endpoints, and ensuring ethical compliance, all of which are crucial in generating the required safety and effectiveness data.

Post-market compliance. Once the device is on the market, a medical device consultant helps ensure that it continues to meet regulatory requirements. This encompasses areas such as adverse event reporting, recalls, and periodic reviews, maintaining the device’s compliance throughout its lifecycle.

Market analysis and commercialization strategy. Beyond regulatory compliance, medical device consultants offer insights into market trends, the competitive landscape, and optimal strategies for market entry and growth. Their expertise can identify opportunities, challenges, and best practices for successful commercialization.

Challenges and Pitfalls in Medical Device Classification

Despite clear guidelines, the classification process is not without its challenges:

Ambiguous cases. Innovative devices may not fit neatly into existing categories, leading to confusion.

Changing regulations. Global regulatory landscapes can differ significantly, requiring tailored strategies for different markets.

Cost and time constraints. The regulatory process can be time-consuming and expensive, particularly for small manufacturers. A medical device consultant can streamline the process, but the challenges remain.

The Future of Medical Devices and the FDA

The field of medical devices is continually evolving. New technologies such as 3D printing, artificial intelligence, and personalized medicine are reshaping the industry. A medical device consultant will continue to play an essential role in navigating the regulatory challenges these innovations present.

Future trends may include:

Increased focus on patient-centric devices: Products designed with patient input and tailored to individual needs.

Emerging technologies: Incorporation of advanced technologies like augmented reality and machine learning into medical devices.

Harmonization of global regulations: Efforts to create more standardized regulatory frameworks across different countries and regions.

Conclusion

Understanding FDA medical device classes is a critical aspect of healthcare innovation and safety. The intricate process of classification reflects the multifaceted nature of medical devices, and the role of a medical device consultant is paramount in navigating this landscape. For more details visit us at https://gmppros.com/.

As we continue to explore the possibilities of medical technology, the collaboration between regulators, manufacturers, medical professionals, and consultants will be key to ensuring that these innovations reach patients safely and effectively.

Whether you are a manufacturer, healthcare provider, or simply an interested individual, we hope this guide has illuminated the complex and exciting world of medical devices, demonstrating the crucial balance between technological advancement and patient safety.

Excelling in Regulatory Compliance: Key Principles and Strategies

The Influence of Regulatory Affairs on the Pharmaceutical Industry with pharmaceutical regulatory compliance

Basics of the Pharmaceutical Distribution Process

#medical device consultants

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soelim-blog · 1 year

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The Future of Medical Device Regulation in South Korea: Trends and Challenges

South Korea, with its advanced healthcare system and technological prowess, has emerged as a key player in the global medical device industry. If you're a manufacturer looking to enter the Korean market, understanding and complying with the country's medical device regulations is crucial. In this blog post, we'll explore Soelim, a vital aspect of medical device regulation in korea, and how it impacts manufacturers and consumers alike.

Medical Device Regulation in Korea

Before we delve into Soelim, let's establish a basic understanding of medical device regulation in Korea. Like many countries, South Korea has stringent regulatory requirements in place to ensure the safety and efficacy of medical devices. These regulations are overseen by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA).

Key components of medical device regulation in Korea include:

1. Classification: Medical devices are categorized into classes based on their potential risks. The classification determines the level of scrutiny and documentation required for approval.

2. Quality Management Systems: Manufacturers must adhere to international quality standards such as ISO 13485 to ensure the consistent quality of their devices.

3. Clinical Trials: Depending on the device class and intended use, clinical trials may be required to demonstrate safety and effectiveness.

4. Labelling and Packaging: Strict labelling and packaging requirements are in place to provide essential information to users and healthcare professionals.

5. Post-Market Surveillance: Continuous monitoring of devices in the market to identify and address safety concerns.

Understanding Soelim Soelim, also known as "Pre-Market Approval (PMA)," is a critical component of the Korean medical device regulatory framework. It's the process through which medical devices gain official approval.

visit-http://soelim.com/

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cert3global · 1 year

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A US FDA 510K is a filing that contains enough details about a device to show that it is at least as safe and efficient as similarly advertised medical products that do not require PMA approval. If pre-market approval is not required, companies wanting to introduce Class I, II, and III medical devices for human use in the United States must submit a 510k.

#UKCA Marking

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firstbuzz · 1 year

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Airlines, repair shops in North America rely on used, generic parts to keep aircraft flying

Airlines and aircraft repair shops in North America are increasingly relying on used and generic parts to keep jets flying, a symptom of the rising costs and supply-chain shortages plaguing the aerospace industry.

These alternatives to new parts made by the original manufacturer must be certified and deemed safe. While they account for a fraction of the estimated $35 billion spent annually on components for repairs, sales are growing, analysts and executives say.Driving demand is the struggle aerospace suppliers face to fill new orders as air traffic soars and the supply chain for aircraft parts recovers from the Covid-19 pandemic, when labor shortages and lockdowns slowed production.Higher costs and a shortage of available new parts are also delaying aircraft repairs, which risk pushing up air fares. That has spurred demand from airlines and repair shops for alternatives that cost roughly 20% to 40% less than new parts, analysts and executives said. Some makers of brand-name parts like General Electric Co stand to benefit because they also sell used parts, known as used serviceable material.Some planemakers are also benefitting. Business jet maker Bombardier Inc uses a teardown venture to gain parts for its growing "aftermarket" business that provides maintenance and repairs for planes.The venture has helped the company source parts for older aircraft models that are harder to find in the current market, or are no longer being produced, a spokesman said.American Airlines, meanwhile, says it has helped develop certified parts that were not made by the original manufacturer to mitigate "increased costs and other supply chain constraints."Companies spent $35 billion in 2019 on materials for aviation repairs and overhauls, including $5 billion on used parts and $725 million on generic components, aerospace specialist Naveo Consultancy estimates.It declined to disclose figures for the following years, but analysts at Naveo and others say demand for alternatives to new parts is rising.Honeywell Aerospace Trading, the U.S. conglomerate's used parts business, is among companies enjoying higher demand since 2021. It expects demand to continue through at least the first half of 2024 as the supply chain recovers, said Heath Patrick, president for the Americas aftermarket segment at Honeywell Aerospace.The market for new generic parts with a Parts Manufacturer Approval stamp from the U.S. Federal Aviation Administration (FAA) may be small - representing just 2% to 3% of spending on materials - but growth is outstripping overall market trends, said Adam Guthorn, managing director at aerospace consultancy Alton.HEICO Corp, a major independent supplier of new FAA-approved parts not made by the original manufacturer, expects demand to continue even after supply bottlenecks improve, vice president Patrick Markham said."Growth will be stronger than pre-pandemic" in the next few years, he said. HEICO's profit in its latest fiscal year ending Oct. 31 rose 16% to a record $351.7 million, helped by booming sales of parts with the PMA stamp.Companies like GE could lose some demand to such independent companies producing certified components that perform the same fit and function, as they can be cheaper and easier to procure in the current environment, said Abdol Moabery, CEO of Florida-based GA Telesis, which repairs and overhauls jet engines.GE, in response, says it provides customers with used material that can "significantly lower shop visit costs."The market for certified used and generic parts has its limits. For example, parts makers face the same labor shortages that have hit all companies, analysts said.

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medicaldeviceconsultantinus-blog · 2 years

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Medical Device FDA 510 k consulting company | Operon Strategist

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre-market clearance ” is took from the FDA the device can be distributed commercially immediately.

There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).

In the United States, this frequently means submitting a 510( k). A 510( k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration( FDA) for “ clearance ” before you can deal your device in the U.S. In order to receive clearance from the FDA, your 510( k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device).

What Exactly is Substantial Equivalence?

Now that we know what a 510( k) is, let’s talk about the substantial equivalence standard. You ’ll recall from the intro that your 510( k) must show that the new( or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.

Operon Strategist is a leading medical device consultant providing FDA 510k Clearance process consulting to the customers to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.

We helps during the process of submitting operations for class I, II, III medical devices at any stages of the product development. Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU.S and international customers. These operations include

510( k) Premarket Notifications

Premarket Approval Applications( PMAs)

De Novo Request( Application)

513( g) Requests for Classification

Investigational Device Exemption Applications( IDEs

Investigational New Drug Applications( INDs)

510( k) Premarket Notifications

Operon Strategist provides answers to related questions

Which groups( Class I, II, and III) do we require an FDA 510( k)?

How many stages consist of the 510( k) application process?

A class I, II, and III device intended for human use, for which a Premarket Approval FDA operation( PMA) isn't needed, must submit a 510( k) to FDA unless the device is pure from 510( k) conditions of the Federal Food, Drug, and Cosmetic Act( the FD&C Act) and doesn't exceed the limitations of exemptions in.9 of the device classification regulation chapters(e.g., 21 CFR862.9, 21 CFR864.9). Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States. typically, the FDA shall be subject to a provision of 510( k), should manufacturers intend to deal the Class II Medical Devices and some needed Class I and III bias or IVDs on the US market. Apre-market 510( k) approval is also required for already approved medical devices( Predicate) if the manufacturer( s) modifies the technology or changed the intent of device operation in a way that significantly affects patient safety or device performance.

The 510( k) is generally the most effective route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, rather of demanding to present more expansive clinical trial data.

There are three types of 510( k) Traditional, shortened, and Special. This eBook will begin with a general overview of the 510( k) process, including its purpose and benefits. Next, we will explore the Traditional 510( k) and the sections and factors needed in depth. Finally, we will look at the Special and shortened 510( k).

When is a 510( k) needed?

A 510( k) is needed for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is needed for high- risk or new devices which bear a advanced position of scrutiny to be verified safe and effective.

Complaints

Still, the end user can file a complaint with the FDA or the manufacturer, If a FDA 510( k) cleared medical device isn't performing as intended.

The user or client can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or incorrectly promoting the performance of their device. This is a straightforward process to insure that medical devices on the market are being held to strict standards to make sure it's being used safely and effectively

Things to Consider

Before choosing a product with a FDA 510( k) clearance, it's important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It's also important to make sure to read the indications for use to know how to use the product properly. Eventually, test data that has been transferred to the FDA should be available to the end user, frequently in a confirmation guide or test report.

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

#FDA 510 k consultant #FDA 510 k #FDA 510 k clearance #FDA 510 k submission #medical devices

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freyrsolutions · 3 years

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#DHF #Design History File #medical device #USFDA #DHF guidance #PMA #Pre-market Approval #510(k) clearance letter

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kellyshelton-blog1 · 6 years

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#Medical device classification #510k submission #Medical device recalls #Combination products #IDE submission #Pre-market requirements #Post-market requirements #De Novo submission #Pre-market approvals (PMA)#Medical device registration & listing #Importing/ exporting medical devices #FDA communications

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pranalipawarshinde · 2 years

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Coronary Stents Market to reach the value of US$ 25.7 Bn by the end of 2028

Coronary Stents Market Outlook 2028

The global coronary stents market was valued at US$ 10.1 Bn in 2020

It is estimated to expand at a CAGR of 12.9% from 2021 to 2028

The global coronary stents market is expected to reach the value of US$ 25.7 Bn by the end of 2028

Report Overview: https://www.transparencymarketresearch.com/coronary-stents-market.html

Increase in Demand Due to Rise in Prevalence of Cardiovascular Diseases

The growing incidence of cardiovascular disorders in people across the globe is a major factor driving the coronary stents market during the forecast period. Coronary stents are tubes placed in the coronary artery to clear artery blockages or coronary artery stenosis. They are utilized in a procedure called percutaneous coronary intervention (PCI) or coronary angioplasty. This procedure is a minimally invasive procedure to treat stenosis or narrowing of the coronary arteries. Technology plays an indispensable role in the global coronary stents market. Manufacturers have been undertaking rigorous research and development initiatives to develop nascent products that are functionally superior to their previous versions.

Changes in lifestyle and need of controlling rapidly rising obesity rate are major factors for the treatment of cardio vascular disease (CVD). Percutaneous coronary intervention has become a standard treatment option preferred across the globe for CVD. Increase in awareness about the technological innovations in interventional cardiology and cost effectiveness of the procedure propel stents production.

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Stringent Regulations for Product Approvals in Developing Nations

The approval of medical devices is considered to be expensive. Coronary stents fall under the category III devices of the U.S. FDA. These devices require submission and approval of pre-market approval (PMA) application prior to commercial marketing in the U.S. The requirements of clinical and pre-clinical data for stents engage the sponsor and manufacturer for a long period of time. Resources of manufacturers and investors such as time and money are spent on conducting safety testing and clinical pharmacology and toxicology testing of drug substance in case of DES. The FDA’s regulatory procedures are comparatively time-consuming as compared to that of EMA. Thus, prolonged procedures of drug approval by regulatory authorities in the U.S. deter manufacturers from opting for development and commercialization of stents.

Drug Eluting Stent to be Highly Lucrative Segment

Advancements in the coronary stent technology are expected to augment the market during the forecast period. The drug eluting stent segment is expected to account for a major market share in the upcoming years. There is an increasing risk of stent thrombosis in patients after stopping the antiplatelet therapy. The management of CAD has improved to advances in the drug eluting stent (DES) technology. The advanced technology can be efficiently used to treat patients with coronary artery diseases. New materials are being developed for the treatment such as biodegradable metals, etc. Technological advancements in coronary stents and lucrative presence of manufacturers are driving the global coronary stents market growth.

North America Coronary Stents Market to Expand at Rapid Pace

North America is expected to dominate the global coronary stents market, followed by Europe and Asia Pacific nations such as Japan and China. CVDs are listed as a major cause of mortality across the world, responsible for one in every three deaths in the U.S. The occurrence of restenosis after angioplasty procedure boosts the adoption of novel stents, such as drug-eluting and bioresorbable, which are known to drastically reduce the frequency of restenosis. This factor boosts the demand for coronary stents in North America. High geriatric population, lifestyle changes leading to obesity and related health complications, and advent of advanced technologies such as bio-absorbable and next generation stents are major factors driving the North America coronary stents market.

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Coronary Stents Market: Overview

According to Transparency Market Research’s latest report on the global coronary stents market for the historical period 2017–2019 and forecast period from 2021 to 2028, rise in prevalence of coronary artery diseases (CADs) and increase in global obesity rate are projected to drive the global coronary stents market during the forecast period

Rise in Prevalence of Cardiovascular Diseases: Key Driver

Cardiovascular diseases (CVD) overtook cancer as the leading cause of chronic disease morbidity and mortality in the 20th Century. It has peaked and begun to fall in many countries, while it is rising in developing countries. Risk factors, sociocultural changes, and medical care all play a role in understanding these disease patterns.

According to the World Health Organization, 17.9 million people succumbed to CVDs in 2019, constituting 32% of all global deaths. Around 85% of these deaths were caused by a heart attack or a stroke.

More than three-quarters of CVD deaths occur in low- and middle-income countries. In 2019, non-communicable diseases claimed the lives of 17 million people under the age of 70, accounting for 38% of all premature deaths.

High systolic blood pressure and smoking are the first and second leading risk factors for years of life lost globally in 2019. In the same year, the first and second leading years lived with disability and injury risk factors were high fasting plasma glucose and high body mass index.

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Improvement in Coronary Stents Technology Boosts Market Growth

Coronary stent technology has progressed from a mechanical solution to abrupt vessel closure and elastic recoil after simple balloon angioplasty to a vector for local drug delivery and modification of coronary plaque pathophysiology. The introduction of drug-eluting stents (DES) has significantly reduced restenosis, but there is growing concern about the risk of late stent thrombosis, particularly after stopping antiplatelet therapy.

Management of coronary artery disease has improved to advances in drug eluting stent (DES) technology. They improve long-term patency rates by inhibiting restenosis through the controlled release of an antiproliferative agent, such as Paclitaxel, after deployment.

In the field of stent technology for treating patients with coronary artery disease, there has been a rapid technological advancement. As potential materials for the next generation of cardiovascular system treatment are developed, the use of biodegradable metals as implants will be revolutionized. Hence, enhancement in the coronary stents technology is expected to augment the market during the forecast period.

Stringent Regulatory Approvals to Hamper Market

Stringent regulatory approvals for coronary stents is likely to hamper market growth. The stringent regulatory environment could act as a restraint of the global coronary stents market over the next few years. Various governments and organizations establish guidelines and rules for the safer and more effective use of stents.

The European Association of Percutaneous Cardiovascular Interventions (EAPCI) provides clinical and non-clinical stent guidelines. Additionally, before approving stents, the FDA conducts a thorough systemic review of the literature as well as pre-clinical trials in human.

The Office of Combination Products (OCP) has published regulations for surgeons and physicians to use drug-eluting stents. These stringent rules for the use of stents are projected to hamper the growth of the global market.

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Coronary Stents Market: Competition Landscape

Abbott Laboratories Inc.

Boston Scientific Corporation

Medtronic Inc.

Johnson & Johnson

Terumo Corporation

B. Braun Melsungen AG

C. R. Bard Inc.

Cook Medical Inc.

AMG International GmbH

Biotronik SE & Co. KG

Stentys SA

and MicroPort Scientific Corporation

among others

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