#US FDA’s 510(k) | Explore Tumblr posts and blogs

latestmarketresearchnews · 20 days ago

Text

In Vitro Diagnostics (IVD) Industry Sales, Demand, Regional Outlook And Supply Chain Analysis till 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Research #In Vitro Diagnostics (IVD) Market Forecast

0 notes

researchreportinsight · 20 days ago

Text

In Vitro Diagnostics (IVD) Industry Growth Analysis & Forecast Research Report, 2030

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

End-use Segmentation Insights:

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Research #In Vitro Diagnostics (IVD) Market Forecast

0 notes

marketanalysisdata · 1 month ago

Text

In Vitro Diagnostics (IVD) Industry Size, Trends, Value, Sales and Forecast 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Share #In Vitro Diagnostics (IVD) Market Trends #In Vitro Diagnostics (IVD) Market Growth

0 notes

marketstudyreport · 1 month ago

Text

In Vitro Diagnostics (IVD) Market Growth Analysis & Forecast Research Report, 2030

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Product Segmentation Insights:

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Share #In Vitro Diagnostics (IVD) Market Trends #In Vitro Diagnostics (IVD) Market Growth

0 notes

sigmabiomedical · 1 month ago

Text

510(k) Clearance vs. FDA Approval: What’s the Difference?

Navigating the regulatory landscape for medical devices can be daunting for manufacturers and developers. One of the key aspects of this landscape is understanding the difference between 510(k) clearance and FDA approval. Both are critical processes for bringing medical devices to market in the United States, but they serve different purposes and involve distinct pathways. This blog will explore these differences, providing insight into regulatory consulting for 510(k) submissions and the role of medical device 510(k) consulting in ensuring compliance.

Understanding the FDA's Role

The U.S. Food and Drug Administration (FDA) is the regulatory authority responsible for overseeing the safety and effectiveness of medical devices. The FDA categorizes medical devices based on their risk levels, which determines the regulatory pathway that must be followed before a device can be marketed.

The FDA's Device Classification System

Medical devices are classified into three categories:

Class I: Low-risk devices that are subject to the least regulatory control. These devices often require only general controls to ensure safety and effectiveness.

Class II: Moderate-risk devices that must comply with specific performance standards and typically require a 510(k) submission for clearance.

Class III: High-risk devices that require premarket approval (PMA) because they pose a greater risk to patients. This pathway is more rigorous than the 510(k) process.

What is 510(k) Clearance?

A 510(k) submission is a premarket notification that demonstrates a device is substantially equivalent to a device already on the market (known as a predicate device). The primary goal of the 510(k) process is to ensure that new devices do not introduce new safety or effectiveness concerns.

Key Aspects of 510(k) Clearance

Substantial Equivalence: To obtain 510(k) clearance, manufacturers must provide evidence that their device is as safe and effective as an existing device. This often involves comparing design, materials, and intended use.

Review Process: The FDA typically reviews 510(k) submissions within 90 days, although this timeline can vary based on the complexity of the device and the submission quality.

Documentation: A successful 510(k) submission requires thorough documentation, including data from preclinical and clinical studies, manufacturing processes, labeling, and more.

Role of Regulatory Consulting for 510(k)

Given the complexities involved in preparing a 510(k) submission, many manufacturers turn to regulatory consulting for 510(k). These consultants provide expertise in navigating the regulatory environment, helping to prepare comprehensive submissions that meet FDA requirements.

Guidance on Documentation: Consultants can guide manufacturers in gathering and presenting the necessary documentation, ensuring that the submission is complete and robust.

Predicates Identification: Finding appropriate predicate devices is critical for demonstrating substantial equivalence. Regulatory consultants help identify and evaluate these predicates.

Risk Assessment: Consultants can assist in assessing the risks associated with the device and developing strategies to mitigate them.

What is FDA Approval?

FDA approval, particularly for Class III devices, involves a more rigorous evaluation process known as premarket approval (PMA). Unlike the 510(k) process, PMA requires comprehensive scientific evidence to demonstrate a device's safety and effectiveness.

Key Aspects of FDA Approval

Extensive Testing: The PMA process often requires extensive clinical trials and testing to provide data on safety and effectiveness. This can be a time-consuming and costly endeavor.

Longer Review Process: The FDA may take several months to years to review a PMA application, depending on the complexity of the device and the quality of the submitted data.

Post-Market Surveillance: Approved devices are often subject to post-market surveillance to monitor their performance and safety in real-world settings.

Key Differences Between 510(k) Clearance and FDA Approval

Purpose:

510(k): Demonstrates substantial equivalence to a predicate device.

FDA Approval: Establishes safety and effectiveness through extensive data and testing.

Timeframe:

510(k): Typically reviewed within 90 days.

FDA Approval: May take several months to years.

Data Requirements:

510(k): Requires less extensive data; relies on comparison with existing devices.

FDA Approval: Requires comprehensive scientific evidence, including clinical trials.

Class of Device:

510(k): Generally for Class II devices.

FDA Approval: Primarily for Class III devices.

Conclusion

Understanding the differences between 510(k) clearance and FDA approval is crucial for medical device manufacturers seeking to bring their products to market. While both processes are essential for ensuring the safety and effectiveness of medical devices, they serve distinct roles within the regulatory framework. Engaging in medical device 510(k) consulting can significantly enhance the chances of a successful submission, allowing manufacturers to navigate the complexities of the regulatory landscape efficiently. By leveraging the expertise of regulatory consultants, companies can ensure compliance and focus on what matters most: delivering safe and effective devices to patients.

#510(k) clearance #medical device 510(k) consulting

0 notes

freyrsolutions · 2 years ago

Text

#Medical Devices #Post-approval Changes #510(k) Clearance #US FDA #Regulations #510(K)#510(k) submissions #post-approval change management #medical device products

0 notes

tamanna31 · 2 months ago

Text

Exoskeleton Market Trends, Statistics, Segments, Graphs Growth Factors Forecast to 2030

Exoskeleton Industry Overview

The global exoskeleton market size was estimated at USD 419.5 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 16.6% from 2024 to 2030. In terms of volume, the market volume was 13,643 units in 2023 and is projected to grow at a CAGR of 9.3% from 2024 to 2030. Rapidly growing global geriatric population, rising adoption rates of medical devices in different industries such as automobile, military, defense, and construction, and rising incidence of stroke are some of the key driving forces responsible for the market growth.

Gather more insights about the market drivers, restrains and growth of the Exoskeleton Market

Furthermore, the growing incidence rate of spinal cord injuries (SCI) is expected to drive the demand across global markets. For instance, as per the National Spinal Cord Injury Statistical Center (NSCISC), in the U.S., 17,730 new SCIs are diagnosed annually, and approximately 291,000 live with SCIs.

Exoskeleton solutions are widely adopted across industries to support employee health and boost productivity. Growing demand has led to emergence of several startups expertizing in exoskeleton technology and providing solutions for rehabilitation. Furthermore, constantly evolving exoskeleton industry is driving market players to devise innovative product development strategies to boost adoption over the forecast period. For instance, in June 2022, Ekso Bionics received 510(k) FDA clearance for marketing the EksoNR robotic exoskeleton. It is the latest generation of devices that can be used for rehabilitation of multiple sclerosis patients.

Some of the most common musculoskeletal injuries and disorders affecting the construction industry are occupational overuse syndrome (OOS), cumulative trauma disorders (CTD), and repetitive strain injury (RSI). For instance, as per WHO data estimates published in July 2022, approximately 1.71 billion individuals across the globe have musculoskeletal disorders that include neck pain, lower back pain, fractures, amputation, rheumatoid arthritis, and osteoarthrit is. Similarly, in 2022, according to the U.S. Bureau of Labor Statistics, approximately 502,380 workers have occupation-related musculoskeletal disorders across several industries. These are some of the driving factors boosting adoption of exoskeleton solutions owing to benefits associated with exoskeleton technology, such as augmenting or assisting users’ physical activity or capability, improving users’ health & productivity, and reducing fatigue experienced by industrial workers.

Rapid technological advancements in the global market are expected to boost the demand for exoskeletons. Increasing popularity and growing adoption of exoskeletons by companies are expected to contribute to market growth. In addition, increasing adoption of exoskeletons in manufacturing sector, logistics, automotive, and construction is leading to a rise in penetration of exoskeletons, thereby fueling the market growth. For instance, in December 2021, IKEA and BMW are using Bionic’s fifth generation Cray X, an AI-enabled, powered exoskeleton capable of lifting an additional 70 pounds, reducing the risk of repetitive stress injuries and back injuries. Such advancements are expected to boost market growth over the forecast period.

Browse through Grand View Research's Medical Devices Industry Research Reports.

• The global disposable hospital gowns market size was valued at USD 3.68 billion in 2023 and is projected to grow at a CAGR of 12.9% from 2024 to 2030. The heightened focus on infection control within medical settings fuels the demand for disposable gowns.

• The global knee braces market size was valued at USD 1.12 billion in 2023 and is projected to grow at a CAGR of 7.7% from 2024 to 2030. The rise in osteoarthritis (OA) cases, orthopedic knee surgeries, athletic injuries and other knee related injuries are fueling the growth of the knee brace industry.

Exoskeleton Market Segmentation

Grand View Research, Inc. has segmented the exoskeleton market report based on mobility, technology, extremity, structure, end-use, and region:

Exoskeleton Mobility Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Mobile • Fixed/Stationary

Exoskeleton Technology Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Powered • Non-powered

Exoskeleton Extremity Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Upper Body • Lower Body • Full Body

Exoskeleton Structure Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Rigid Exoskeletons • Soft Exoskeletons

Exoskeleton End-Use Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Healthcare • Military • Industry

Exoskeleton Regional Outlook (Volume, Revenue, USD Million, 2018 - 2030) • North America o US o Canada • Europe o Germany o UK o Spain o Italy o France o Denmark o Norway o Sweden • Asia Pacific o Japan o China o India o Australia o Thailand o South Korea • Latin America o Brazil o Mexico o Argentina • MEA o South Africa o Saudi Arabia o UAE o Kuwait

Key Companies profiled: • Ekso Bionics • Hocoma • Lockheed Martin Corporation • Suit X • Rex Bionics Plc. • RB3D • ReWalk Robotics • Cyberdyne, Inc. • ActiveLink (Panasonic Corporation)

Order a free sample PDF of the Exoskeleton Market Intelligence Study, published by Grand View Research.

Key Exoskeleton Company Insights

• Ekso Bionics specializes in bionic exoskeletons, robotics, and rehabilitation. Ekso Bionics received its first FDA clearance for exoskeleton for patients affected with spinal cord injuries and stroke. The company is a leader in technology innovation and is one of pioneers in the market. The company also focuses on partnering with established healthcare facilities to expand their distribution channels and enhance care delivery in newer business geographies

• Cyberdyne, Inc. develops and distributes exoskeleton suits widely used in medicine, caregiving, and living & labor support. The company has been devising various business expansion strategies such as mergers and technological collaborations. The company focuses on collaborating with different stakeholders of the supply chain, thereby increasing its clientele and expanding their business geography

• Lockheed Martin Corporation is a large company dealing in aerospace, security, defense, and other technologies. The company has expertise in developing exoskeleton or exo-robots for the military and defense industries. The company focuses on obtaining defense service contracts

Recent Developments

• In December 2023, German Bionic introduced the Apogee exoskeleton with robotic motors for healthcare workers to lift and move heavy patients with greater ease, less strain, and improved stamina

• In June 2022, CYBERDYNE Inc. formed a business and capital alliance with LIFESCAPES Inc. This collaboration highlighted the combined effort to further leverage the exoskeleton technology arena and improve rehabilitation options for patients with severe paralysis

• In June 2022, Ekso Bionics received 510(k) FDA clearance for marketing the EksoNR robotic exoskeleton. It is the latest generation of devices that can be used for the rehabilitation of multiple sclerosis patients

• In February 2020, Ekso Bionics launched EksoPulse platform, a cloud-deployed platform to measure and analyze EksoNR robotic exoskeleton. The platform is integrated with a user-friendly interface and dashboard to measure activity & progress in rehabilitation sessions

• In November 2018, Lockheed Martin received a USD 6.9 million development contract from the U.S. Army Natick Soldier Research, Development, and Engineering Center (NSRDEC) to further develop the Onyx exoskeleton for soldier demonstrations

0 notes

mysteriouslyelegantpanda · 2 months ago

Text

Navigating Medical Device Compliance: Expert Regulatory Consulting Services

In the highly regulated field of medical devices, ensuring compliance with industry standards and regulations is crucial for bringing products to market and maintaining their legality. Medical Device Regulatory Consulting Services are essential for companies looking to navigate complex regulatory landscapes and achieve successful product launches. Here’s how expert consulting services can help streamline the process and ensure your medical devices meet all necessary requirements.

Understanding Medical Device Regulations

1. Global Regulatory Landscape

Medical device regulations vary significantly across different regions, including the U.S., Europe, and other international markets. In the U.S., the FDA (Food and Drug Administration) sets rigorous standards for medical devices, while the European Union has its own set of regulations under the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). Understanding these regulations is essential for global market access.

2. Classification and Requirements

Medical devices are classified based on their risk levels, intended use, and technological characteristics. Each classification has specific regulatory requirements that must be met. Consulting services help determine the appropriate classification for your device and guide you through the corresponding regulatory pathways.

Key Benefits of Medical Device Regulatory Consulting Services

1. Expert Guidance on Compliance

Regulatory consultants provide expert advice on navigating the complex regulatory requirements for medical devices. They ensure that your device meets all necessary standards, including safety, effectiveness, and quality, helping you avoid costly delays and non-compliance issues.

2. Streamlined Submission Processes

Consultants assist in preparing and submitting regulatory documents, including 510(k) submissions, PMAs (Premarket Approvals), CE Mark applications, and other necessary paperwork. They help ensure that submissions are complete, accurate, and compliant with regulatory requirements, expediting the approval process.

3. Risk Management and Quality Assurance

Effective risk management and quality assurance are critical for medical device compliance. Consultants help implement robust risk management plans, conduct thorough documentation reviews, and establish quality management systems (QMS) that align with ISO 13485 standards, ensuring ongoing compliance throughout the product lifecycle.

4. Market Access and Strategy

Consultants provide strategic advice on market access, helping you understand and meet the specific requirements for different regions. They assist in developing regulatory strategies that align with your business goals and facilitate smoother entry into international markets.

5. Ongoing Support and Updates

Regulatory requirements are constantly evolving, and staying up-to-date is essential. Consulting services offer ongoing support and updates on regulatory changes, helping you adapt to new requirements and maintain compliance over time.

Choosing the Right Regulatory Consulting Partner

1. Experience and Expertise

Select a consulting firm with extensive experience and expertise in medical device regulations. Look for consultants who have a proven track record of successful submissions and regulatory approvals in your specific device category.

2. Understanding of Your Industry

Choose a consultant who understands your particular industry segment and the unique challenges associated with your device. Their industry knowledge will be invaluable in addressing specific regulatory concerns and ensuring compliance.

3. Personalized Service

Opt for a consulting firm that offers personalized service and is responsive to your needs. Effective communication and a tailored approach are crucial for addressing your specific regulatory challenges and achieving successful outcomes.

Conclusion

Medical device regulatory consulting services play a vital role in helping companies navigate the complex regulatory landscape and achieve compliance. By leveraging expert guidance, streamlined submission processes, and ongoing support, you can ensure that your medical devices meet all necessary requirements and successfully enter the market. Partnering with a reputable consulting firm will provide you with the expertise and resources needed to achieve regulatory success and maintain ongoing compliance.

#Medical Device Regulatory Consulting Services

0 notes

markjasonstubblefield · 2 months ago

Text

Understanding the Importance of Regulatory Compliance in Device Sales with Sales Professionals including Jason Stubblefield

Mark Jason Stubblefield

Understanding the Importance of Regulatory Compliance in Device Sales with Sales Professionals including Jason Stubblefield

Selling medical devices in the United States involves navigating a complex regulatory landscape. Regulatory compliance is not only crucial for legal operations but also ensures that products meet safety and efficacy standards critical to protecting patient health. The U.S. Food and Drug Administration (FDA) oversees the regulation of medical devices, enforcing stringent guidelines that manufacturers and sellers must follow. Understanding and adhering to these regulations is essential for successfully entering and thriving in the medical device market.

This blog will explore the importance of regulatory compliance in medical device sales, covering key aspects such as FDA requirements, documentation and labeling, and quality management systems. Additionally, we will address the significance of post-market surveillance, navigating compliance challenges, and the role of legal and regulatory advisors. By comprehending and implementing these regulatory measures, businesses can ensure their products are compliant, safe, and market-ready.

FDA Requirements for Medical Devices

The FDA plays a pivotal role in regulating medical devices in the U.S. Each device must meet specific regulatory requirements before it can be marketed. These requirements vary based on the device's classification, which ranges from Class I (low risk) to Class III (high risk). Class I devices generally require less regulatory control, while Class II and III devices undergo more rigorous scrutiny, including premarket notification (510(k)) or premarket approval (PMA).

Understanding the classification of your device is essential for determining the appropriate regulatory pathway. For example, Class II devices often require a 510(k) submission demonstrating that the device is substantially equivalent to an already legally marketed device. Conversely, Class III devices typically require a more extensive PMA process, including clinical trials and comprehensive data analysis. Adhering to these requirements ensures that your device meets safety and efficacy standards, paving the way for successful market entry as highlighted by leaders like Jason Stubblefield.

Documentation and Labeling Requirements

Proper documentation and labeling are crucial aspects of regulatory compliance in medical device sales. The FDA mandates that all medical devices have accurate and comprehensive labeling that includes information on the device's intended use, directions for use, and any warnings or contraindications. This labeling helps ensure that healthcare providers and patients use the device correctly and safely.

Documentation requirements also extend to maintaining detailed records of design, manufacturing, and testing processes. These records must be readily available for FDA inspections and audits as emphasized by industry leaders such as Jason Stubblefield. Comprehensive documentation supports the device's approval process and provides a clear trail of compliance, which is essential for addressing any regulatory queries or issues that may arise.

Quality Management Systems

A robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical devices. The FDA requires manufacturers to implement a QMS that adheres to the principles outlined in 21 CFR Part 820, also known as the Quality System Regulation (QSR). This system ensures that devices are consistently produced and controlled to meet quality standards.

Key components of a QMS include quality planning, risk management, design control, and corrective and preventive actions. Implementing these practices helps identify and mitigate potential risks, ensure product reliability, and maintain compliance with regulatory requirements. Sales professionals including Jason Stubblefield convey that regular internal audits and inspections are also part of a QMS, helping to identify and address any non-compliance issues before they become significant problems.

Post-Market Surveillance and Reporting

Post-market surveillance is essential for monitoring the performance and safety of medical devices once they are on the market. The FDA requires manufacturers to collect and analyze data on device performance, adverse events, and user feedback. This ongoing surveillance helps identify potential issues early and ensures that devices continue to meet safety standards throughout their lifecycle.

Manufacturers must also report any adverse events or device malfunctions to the FDA in a timely manner. These reports contribute to a broader understanding of device safety and effectiveness, and may lead to additional regulatory actions or product recalls if necessary. Effective post-market surveillance and reporting are critical for maintaining regulatory compliance and protecting patient health as underscored by leaders like Jason Stubblefield.

Navigating Compliance Challenges

Navigating regulatory compliance can present challenges, particularly for businesses new to the medical device industry. Common issues include understanding complex regulatory requirements, managing extensive documentation, and maintaining up-to-date knowledge of regulatory changes. Addressing these challenges requires a proactive approach and a thorough understanding of FDA guidelines.

Engaging with regulatory experts, consultants, or legal advisors can help overcome these challenges. These professionals can provide guidance on regulatory strategy, assist with documentation and submission processes, and help ensure that your device remains compliant with evolving regulations. Leveraging their expertise can streamline compliance efforts and mitigate potential risks associated with regulatory non-compliance.

Role of Legal and Regulatory Advisors

Industry leaders such as Jason Stubblefield express that legal and regulatory advisors play a crucial role in ensuring that medical device sales adhere to all applicable regulations. These professionals offer valuable insights into regulatory requirements, assist with navigating complex approval processes, and provide support during FDA inspections and audits. Their expertise helps ensure that your device complies with all necessary regulations and minimizes the risk of legal issues.

Advisors can also assist in developing and implementing effective regulatory strategies, addressing compliance challenges, and managing any disputes or issues that arise. By collaborating with these experts, businesses can enhance their understanding of regulatory requirements, streamline their compliance efforts, and focus on successfully bringing their medical devices to market.

Regulatory compliance is a fundamental aspect of selling medical devices in the U.S., ensuring that products meet safety and efficacy standards while protecting patient health. Understanding FDA requirements, maintaining proper documentation, implementing a robust Quality Management System, and engaging in effective post-market surveillance are essential for achieving compliance. Additionally, navigating compliance challenges and leveraging the expertise of legal and regulatory advisors further support successful market entry.

By prioritizing regulatory compliance, businesses can enhance their credibility, avoid potential legal issues, and ensure that their medical devices meet the highest standards of safety and effectiveness. This commitment to compliance not only facilitates market success but also contributes to the overall advancement of healthcare.

#Mark Jason Stubblefield

0 notes

biotech-news-feed · 3 months ago

Link

The FDA has issued 510(k) clearance for Think Surgical’s Tmini miniature robotic system to be used with Zimmer Biomet's Persona knee system. The post FDA issues 510(k) clearance for Think Surgical’s Tmini use with Persona system appeared first on Me #BioTech #science

#Blockchain #Crypto

0 notes

poojapandit · 3 months ago

Text

Right time to Submit USFDA 510(k): Timing Your FDA Application Strategically

Understanding the USFDA 510(k) Submission: A Key to Medical Device Success

Navigating the USFDA 510(k) submission process is crucial for medical device manufacturers aiming to enter the U.S. market. This regulatory step ensures that your device is substantially equivalent to an existing legally marketed device in terms of safety and effectiveness. Proper execution of this process can significantly enhance market success, provide a competitive edge, and ensure patient safety.

Why Timeliness and Accuracy Matter

Timely and accurate 510(k) submissions offer several distinct advantages:

Market Advantage: Submitting your 510(k) early allows you to seize market opportunities and gain a competitive edge. To learn more about the right timing for your submission, visit this guide.

Efficient Review: A well-prepared submission provides the FDA with the necessary information for a thorough review, reducing the likelihood of delays. Ensure your submission aligns with guidelines by checking out our detailed advice.

Swift Approval: Accurate submissions result in quicker approvals, accelerating your device's market entry. For tips on optimizing your submission timing, refer to this resource.

Key Points About the 510(k) Process

The 510(k) process involves demonstrating that your device is similar to an existing, legally marketed device. This submission is primarily required for moderate-risk Class II devices but may also apply to some Class I and Class III devices.

Identifying a suitable predicate device is crucial. Ensure it matches your device in intended use and technological characteristics. If significant modifications or new performance data are involved, a new 510(k) submission is necessary. For further details on submission timing and requirements, visit our guide.

For expert guidance on your 510(k) submission, Operon Strategist offers comprehensive support to streamline the process and ensure regulatory success. Explore our services to learn more.

Need Expert Assistance? Contact Operon Strategist today for expert advice on your 510(k) submission and achieve a successful market entry.

0 notes

ronkilgarlinjr · 3 months ago

Text

Ron Kilgarlin & American Screening Corp: Shaping the Future of Diagnostics at ADLM 2024 in Chicago

ADLM is the Association for Diagnostics & Laboratory Medicine. It was previously known as the American Association for Clinical Chemistry (AACC). The annual convention of ADLM is conducted every year in Chicago. ADLM 2024 provides opportunities for networking, learning, and professional development. This year ADLM 2024 brought together Global Leaders having extensive experience in Diagnostics & Laboratory Medicine. It features 5 plenary, 70 scientific sessions, more than 170 roundtables, and a showcase of over 700 posters.

American Screening Corporation is an ISO 13485 manufacturer and distributor of Rapid Drug Testing Devices. Incepted in the year 2004 by the great vision of Ron Kilgarlin, ASC supplies medical testing accessories and supplies. Serving its clients for the last 20 years, ASC has grown to be a reliable concern with the highest satisfaction of all its customers in 27 countries.

Owing to the reason that drug consumption at work places is becoming very hazardous, drug testing is necessary to provide a safe and secured atmosphere both to the concern and people.

American Screening Corporation is playing a significant role in Shreveport, Louisiana by supplying rapid drug testing kits to employers and health workers, thus creating a safe and clean environment.

ASC offers high quality drug testing kits which are FDA 510(K) approved and CLIA waived and medical accessories with high quality. ASC distributes Drug Test Kits, which uses Urine, Blood, Saliva, Hair and Sweat to screen for prohibited drugs and alcohol.

The main focus of ASC is bringing to limelight the significance of medical laboratory testing which plays a pivotal role in the early detection, diagnosis and treatment of disease in patients. When a patient regularly undergo lab testing, preventative treatment is possible immediately in the case of any health problem, which could save the patient life.

ASC has participated in ADLM 2024 and have displayed their modern, highly sophisticated and newly introduced drug testing kits in the conference and also displayed posters on new devices and gadgets.

The Role of Ron & American Screening Corp in Diagnostics

American Screening Corporation strives to fulfil its Mission, “We pledge to give you the ultimate in customer service and product support to meet your Drug Test, Point of Care and Medical Supply needs.” ASC holds its core values of Inspirational, Disciplined, Accountable, Execution, Aligned and Transparency to be the supreme ideal.

ASC manufactures Drug Test Specimen Cups, 4 Panel to 21 Panel Drug Test Cups, Urine Test Kits, Alcohol Test Kits, Medical Test Kits, Pregnancy Test Kit, Oral Swab Drug Test Kit, CLIA Waived Saliva Drug Test Kits, Urine Dip Stick, Specimen Collection Kits, Drug and Alcohol Testing Breathalyzers and Home Drug Test Kits along with Medical Supply, Nitrile Gloves and Earloop Mask.

ASC’s drug test kits are used extensively in many places like Work Places, Educational Institutions, Law Enforcement Agencies, Medical Facilities, Rehabilitation Centres, Research Facilities and Shelters for disabled people.

American Screening Corporation has recently launched their new drug testing products which are highly accurate and updated to give quick and reliable results. Precision Plus Drug Test Cups, Discover Drug Test Cups, Psilocybin Mushroom Test Dip Card, Reveal Premium Saliva Drug Test Kit and Specimen Cup with Temp Strip are the new products which are very helpful in screening for abused substances in the most comfortable and convenient way.

ADLM 2024: A Premier Event in Diagnostic Medicine

The main aim of ADLM 2024 conference is to listen to the experts of Diagnostics & Laboratory Medicine instruments and devices, exchange ideas, present innovative ideas, share the merits and demerits and develop collaborations. It also serves to promote scientific and technical advances in Diagnostics & Laboratory Medicine, by providing a platform for communication and visibility.

ADLM 2024 conference offer the opportunity to meet people in person, which can help you build stronger and more meaningful connections with people who are working on diagnostic instruments and devices. This get to gather helps in exchanging ideas, creates network between people who share common vision and ideas and builds lasting relationships.

ADLM 2024 paves a way for attendees to build bridges, both personally and professionally, and to learn about what can be applied to your home institution or to your home field. This is a meeting that is complimentary and synergistic with the diversity of roles that clinical laboratories have in their day-to-day lives.

Medical laboratory testing plays a crucial role in the early detection, diagnosis and treatment of disease in patients. If a patient routinely submits to lab testing, this may allow doctors to respond swiftly with preventative treatment, which could save the patient time, money, and possibly sickness in the future.

ADLM 2024 had 70 Scientific Sessions which brought the latest scientific advances and practical tools on all aspects of laboratory medicine. The conference had variety of formats from case-based discussion, point-counterpoint, mock courtroom, and more. Scientific Sessions also include specially developed and invited sessions from ADLM collaborations and divisions.

The sessions included topics such as:

Laboratory Medicine’s Lead Role in Ensuring Health Equity, Point-of-Care Diagnostics Provide Equitable Access to Healthcare and Interdisciplinary Approaches to Eliminate Maternal Health Inequities.

Real-Time Mass Spectrometry: Strategies for Rapid Drug and Metabolite Detection to Enhance Clinical Decision Making Moderator, Past, Present, and Future Clinical Mass Spectrometry Applications and Design and Implementation of Direct to Mass Spectrometry Drug Screening in Children.

Emerging Nano-Engineering Technologies for the Management of Chronic Diseases and Cancers Moderator, Performance Characteristics and Validation in Non-Blood Analysis, Saliva Based Technologies for the Management of Chronic Disease and Cancer and Application of Nano-Engineering Technologies in Cancer.

Ethical Decision Making for Laboratory Professionals Moderator, Ethical Issues in Laboratory Medicine and Ethical Issues Arising From Direct-To-Consumer Genetic Testing.

Other major exhibits of ADLM 2024 are The MAGLUMI X series which is a new diagnostic technology which gives a high performance with a small footprint.

Another new technology is SATLARS-T8 which offers total laboratory automation solutions. This powerful system is designed for high throughput and flexibility, featuring intelligent functions and compatibility with multidisciplinary equipment. In addition to these advancements, unique solutions in biochemistry were also presented, as well as the latest equipment for molecular diagnostics and haemostasis testing, to their global partners.

Ron & American Screening Corp’s Participation at ADLM 2024

American screening Corporation has introduced Precision Plus 14 Panel Drug Test Mega Cups in ADLM 2024, which are 2 times bigger strips with very clear visibility. Precision Plus 14 Panel drug test mega cups are widely used in work places to screen for 18 as well as 20 different illegal drugs and substances along with pH, SG and Creatinine from the urine sample. They are very easy to use and the instructions are given

Another noteworthy introduction is AT800 Police-Grade Accuracy Breathalyzer which can detect alcohol immediately the moment one breathes into the device. It is a hand held device in the shape of an old mobile phone model.

Other new introductions are Discover Plus 21 Panel Drug Test Cup is self-contained, tamper resistant and can test up to 23 drugs. Custom configurations are available on all 21 panel drug test Discover Plus. It is engineered with Advanced Drug Screen (ADS) technology, which gives accurate, efficient, and comprehensive drug testing.

American Screening Corporation’s another significant device is Psilocybin Dip Card test, which is a rapid, qualitative immunoassay screening, designed for the specific detection of psilocybin, the primary psychoactive compound found in magic mushrooms.

Reveal Premium Saliva Drug Test Kits are offered by American screening Corporation. This test provides an accurate, rapid and non-invasive method for detecting 12 various drugs simultaneously from human saliva. This test is an alternative to traditional urine drug tests.

Shaping the Future of Diagnostics

Ron Kilgarlin and American Screening Corporation are highly interested in innovative ideas to make diagnosis accurate, quick and easy and all the above newly introduced devices and instruments are designed for convenient use and with modern technology.

Artificial intelligence plays a significant role in healthcare and there is almost no area of medical care where AI cannot be used. The recent trend in Technology shows that AI can be used widely ranging from diagnosing a disease like cancer and up to its treatment using radiotherapy. AI helps the human kind by its accurate application. Also AI is used in Eye Care, Pregnancy test, Ultrasound Scanning, CT Scanning, ECG, Cardiology, MRI and Plastic Surgery and indeed very helpful for patients undergoing treatments. The accurate information given by AI assists in making definite decisions by the doctors on the treatment which certainly saves time and lower costs. In short AI is a game changer in the field of healthcare, improving the quality of treatment, thus ensuring that patients get well soon and return to their normal routine very quickly.

Ron Kilgarlin strongly believes that AI can completely redefine patient care management, drug discovery and healthcare administration. AI-driven robots can provide round the clock monitoring, treatment plans and enhancing patient support. In drug discovery, AI enhances the drug development process by analysing how different drugs will function and react in the body, thereby decreasing the time and cost of treatment.

Ron Kilgarlin is of deep conviction that that in a very short time AI would be dominating healthcare industry both in diagnosis and treatment which would surely be highly beneficial to the people. This adoption of Artificial Intelligence will certainly improve the scenario of medical diagnosis in recent future and treatment in hospitals and clinics.

Conclusion

American Screening Corporation has exhibited their new innovative products and gadgets in ADLM 2024. The instruments used for medical diagnosis attracted many participants to the booth. ASC offered its support to medium and small sized distributors and also offered great discounts to all their new advanced drug testing kits along with free delivery. It turned out to be a huge success with lot of customers taking interest in the diagnostic gadgets. One can visit the website of ADLM 2024 and ASC’s face book to know more about the proceedings and the instruments displayed in the booth.

Visit our website www.americanscreeningcorp.com and our customer care team will help you to select the drug testing needs and medical supplies as per your need and specification.

For bulk ordering and volume discounts please call us at (866) 526–2873 or email us at [email protected]

#ronkilgarlin #americanscreeningcorp #healthcare

0 notes