Strategic Regulatory Support for US Market Entry

Navigating the US regulatory landscape is critical for ensuring the safety and efficacy of IVDs and medical devices entering the market. The process of FDA US Medical Device Registration is overseen by the Food and Drug Administration (FDA), which plays a vital role in regulating medical devices in the United States. For companies seeking to enter the US market, partnering with Pure Global offers a strategic advantage. Our team includes senior-level FDA medical reviewers, clinical trial development experts, and Regulatory Affairs Certification (RAC) holders, ensuring a comprehensive understanding of FDA US Medical Device Registration requirements. Strategically located on the East Coast in Maryland, New Jersey, and New York, and on the West Coast in California, our team facilitates efficient engagement with regulatory authorities and a deep understanding of US regulatory nuances.

Leveraging Expertise in Regulatory Affairs and Clinical Laboratories

Pure Standard Lab Corp, a CLIA/CAP certified clinical laboratory based in South Haven, Mississippi, specializes in molecular testing for infectious diseases and cancers. The lab was designed to support biomarker-driven development programs, focusing on assay development and clinical trial studies. Our approach begins with expertise in key biomarker analysis methods, such as immune monitoring, genomics, and bioanalysis. We then build on this foundation by developing cutting-edge technologies and customized biomarker assay approaches to generate rich, multi-omic data. This success sets Pure Global apart from other contract research organizations and biomarker labs, placing us at the forefront of innovative diagnostics.

This partnership with Pure Global provides clients with not only access to seasoned regulatory expertise in FDA US Medical Device Registration but also state-of-the-art clinical laboratory capabilities. This dual advantage is particularly valuable for navigating the complex regulatory environment, as our in-house laboratory accelerates the validation and approval processes for medical devices and IVDs.

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Q&A on above article

Thank you for your piece. I found it insightful and interesting. Especially the topic of diversity action plan, but what does this mean in simpler terms?

[YW]: The FDA’s diversity action plan for in vitro diagnostics (IVD) and medical devices is aimed at ensuring that clinical studies for these products involve patients from a variety of backgrounds. This means including people of different races, ethnicities, genders, and experiences in the testing process. The goal is to ensure that these devices are safe and effective for everyone, regardless of their background. In simpler terms, it means taking into account how these products might affect people differently based on their race, gender, or other factors so that they can be used safely and effectively by all.

Also, regarding eStar, what does the change in regulation mean in simpler terms and how are we as pure global leveraging supporting our clients.

[YW]: The FDA’s eSTAR program is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device premarket submission. This tool is designed to improve the quality of submissions for a wide range of medical devices and IVD products. By using eSTAR, submitters can ensure that their applications are complete, which helps the FDA review them more efficiently. As of October 1, 2023, all 510(k) submissions must be submitted through eSTAR via the CDRH/FDA Portal. At Pure Global, we support our clients by ensuring their submissions meet these new standards, which helps promote faster access to safe, high-quality medical devices.

 Pure Global's regulatory team has adapted to this change and is well versed in completing e-Star-based submission on behalf of our clients. Please see this link for more information: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program#submit

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