REVOLUTIONIZING URBAN MOBILITY WITH LIGHT RAIL VEHICLES (LRVs) Step into the future of public transportation with modern light rail vehicles, designed to balance mobility, sustainability, and urban planning excellence.

What is LRV: An Introduction

Light Rail Vehicles (LRVs) represent a versatile and efficient urban transit solution. Derived from tram technology, LRVs offer higher capacity and speed while maintaining compatibility with urban environments. They fill the gap between heavy rail systems like metros and buses, operating effectively on short to medium distances. Key features include:

Comparison Between LRVs & Road Traffic

Comparing LRVs to road traffic reveals several advantages and challenges, especially in urban areas where both types of transit coexist. LRVs often bring benefits in terms of efficiency, capacity, environmental impact, and safety, but they also interact closely with road traffic, impacting flow, road infrastructure, and overall urban mobility. Here’s a breakdown of how LRVs compare to road traffic:

Types of Light Rail Vehicles

Light Rail Vehicles (LRVs) are categorized based on their floor height, which impacts accessibility and infrastructure requirements. The two primary types are:

Technical Specifications of LRVs

Typical specifications for LRVs reflect their adaptability to various urban transit needs. Below are key technical attributes:

These specifications demonstrate the balance between capacity, speed, and accessibility that LRVs offer for efficient urban transit systems.

Challenges and Key Operational Considerations for LRVs

Cities face a diverse set of obstacles that require strategic planning, technological investment, community support, and sustainable funding. By acknowledging and preparing for these challenges—such as high costs, urban planning complexities, and technical hurdles—cities can create robust, reliable, and sustainable LRV systems that support broader goals of urban mobility and sustainability. This section provides a detailed exploration of these challenges:

Future Trends in Light Rail Vehicle

Future innovations and transformations in LRV systems are designed to make urban transit faster, more efficient, and sustainable. Here are some key areas of exploration:

Cyient’s LRV Capabilities

Cyient is set to revolutionize the Light Rail Vehicle (LRV) industry with its innovative and intelligent engineering solutions. By offering a comprehensive suite of services, Cyient enhances efficiency, safety, and passenger experience, making it a trusted partner for the development of modern, sustainable transportation systems.

By addressing the critical needs of efficiency, safety, and sustainability, Cyient is positioned as a key player in driving the transformation of the LRV industry and shaping the future of urban mobility.

Conclusion

Cyient stands out as a trusted leader in delivering innovative, sustainable, and efficient LRV solutions. By addressing critical urban mobility needs, Cyient contributes to transforming urban transit systems, paving the way for greener, smarter, and more efficient cities.

Conclusion

The United States Food and Drug Administration (FDA) plays a vital role in safeguarding public health through its regulatory oversight of various products. Key functions include product approval, inspections, enforcement actions, public health education, research, and emergency response. Drug approval pathways, such as 505(b)(2), ANDA, and standard approval processes, are essential for bringing new medications to market. Achieving market clearance in the United States requires careful planning, strict adherence to regulatory requirements, and active engagement with regulatory authorities. Although FDA approval fees are high, they contribute to expediting the drug approval process. Nonetheless, challenges in submitting IND/NDA applications to the FDA persist, including regulatory compliance, data requirements, communication, timelines, resource allocation, and acceptance of foreign clinical studies. Overcoming these challenges requires meticulous planning and close collaboration between sponsors and regulatory authorities.

About the Author

Karuna Nidhi Billa

Karuna Nidhi Billa holds a bachelor’s degree in mechanical engineering and has over 28 years of experience in the rail domain and engineering design. He is an expert in design optimization and product development, with specialized expertise in LRVs and metro system design. In the rail domain, his skills encompass the end-to-end design and engineering of LRVs and metro vehicles, including car body, interior and exterior systems. He has deep experience in developing ergonomic, efficient, and safe passenger spaces, optimizing for durability, and ensuring adherence to industry standards and regulations. His work includes structural design, weight reduction, and material selection to improve energy efficiency and operational costs. Additionally, he is adept at integrating advanced technologies to enhance passenger comfort, safety, and accessibility within the design of LRVs and metro vehicles, making him a versatile and highly knowledgeable professional in the rail engineering sector.

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

FDA's Review Process and Timeline for De Novo Submission Request

• Acceptance review (21 CFR 860.230)

  Upon receipt of a De Novo request, the FDA will conduct an acceptance review. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. If any of the acceptance elements are not included, a justification has to be provided for the omission.

  To aid in the acceptance review, it is recommended to submit an Acceptance Checklist as per the guidance document with the De Novo request that identifies the location of supporting information for each checklist element.

  The De Novo request will not be accepted and will receive a Refuse to Accept (RTA) designation if one or more of the elements noted as RTA items in the Acceptance Checklist are not present and no explanation is provided for the omission(s). However, during the RTA review, the FDA staff has the discretion to determine whether the missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted.

  Within 15 calendar days of the Document Control Center receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following:

  • The De Novo request has been accepted for substantive review;
  • The De Novo request has not been accepted for review (i.e., considered RTA) and the requester has 180 calendar days to fully address the RTA notification; or
  • The De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.

• Substantive review

  Once the De Novo request is accepted for substantive review, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm that the device is eligible for De Novo classification.

  During the substantive review of a De Novo request, the FDA may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information.

  If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. If an Additional Information letter is sent, then the De Novo request will be placed on hold. The requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.

  Note: The response must be sent to the DCC within 180 calendar days of the date of the Additional Information letter. No extensions beyond 180 days are granted. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the letter, the request will be considered withdrawn and deleted from the FDA's review system. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device.

  The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the DCC of the appropriate center. The response should—

  • Include the requester's name;
  • Identify the De Novo number;
  • Include the requester's name;
  • Identify the submission as a response to the Additional Information letter;
  • Identify the date of the FDA's request for additional information; and
  • Provide the requested information in an organized manner.

  The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to decide about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request.

CyARC—Accelerated Regulatory Platform

Cyient offers a one-stop solution, CyARC–Accelerated Regulatory Platform, for helping medical device companies to ensure regulatory compliance. Empowered by Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all the functions who have the required skillsets and expertise to support medical device companies throughout the life-cycle of their medical devices.

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

Conclusion

The De Novo submission pathway offers an important regulatory mechanism for launching novel medical devices in the United States market. By understanding the key components of De Novo submission, strategic considerations, and post-market obligations, medical device manufacturers can navigate the regulatory pathway effectively and obtain market clearance for innovative technologies that address unmet clinical needs and improve patient care. While most medical device companies face challenges in their De Novo submissions, collaboration, resource allocation, and strategic planning are essential for achieving successful market entry through the De Novo pathway.

References

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

About the Author

Abhishek Kumar is an SME in Medical Device Regulatory Affairs, Quality Assurance, and Clinical Affairs with over 13 years of experience. He has led the EU MDR-2017/745 sustenance program, identifying business opportunities for sales teams, and managed the engagement program for a US-based medical device company. He has supported the gap assessment, remediation, and submission of 45+ Technical Documentations as per EU MDR, and created 40+ CERs for Class I, II, and III medical devices according to MEDDEV 2.7.1 Rev-4. Additionally, Abhishek has developed proposals for global markets, including Europe, US, ASEAN, China, Taiwan, and Japan, and prepared and implemented regulatory plans for NPD in 90+ countries by analyzing feasibility, defining requirements, and coordinating cross-functional teams.