Combining expert regulatory guidance with cutting-edge clinical laboratory support to streamline the FDA approval process.
The US regulatory process in the US plays a crucial role in ensuring tety and efficacy of IVD and medical devices entering the market. The regulatory landscape in the United States is overseen by the Food and Drug Administration (FDA).
When considering entering the US market, partnering with Pure Global can offer a strategic advantage. With a team comprising senior level FDA medical reviewers, extensive clinical trial development experts, and certified Regulatory Affairs Certification (RAC) holders, Pure Global brings a wealth of regulatory knowledge and experience. This team is strategically located in Maryland, New Jersey, and New York, on the East Coast and in California, on the West Coast. Our team facilitates efficient engagement with regulatory authorities and ensures a comprehensive understanding of US-based regulatory nuances.
Pure Standard Lab Corp, a CLIA/CAP certified clinical laboratory based in South Haven, Mississippi, specializes in molecular testing for infectious diseases and cancers. It was built specifically to support biomarker-driven development programs, with a strong focus on biomarker assay development and clinical trial studies. Our comprehensive approach starts with a foundation of expertise in key biomarker analysis methods such as immune monitoring, genomics, and bioanalysis. We then specialize in developing modern technologies and customized approaches for biomarker assay to generate rich, multi-omic biomarker data. The s uccess of this methodology distinguishes Pure Global from other contract research organizations and biomarker labs.
The partnership with Pure Global not only provides access to a seasoned regulatory team but leverages the company's state-of-the-art clinical laboratory capabilities. This is particularly advantageous for navigating the rigorous regulatory landscape, as having an in-house laboratory can expedite the validation and approval processes.
[YW]: The FDA's diversity action plan for in vitro diagnostics (IVD) and medical devices means they are working to ensure that the subjects or patients involved in developing and testing these devices in clinical studies come from a variety of backgrounds. This includes different races, ethnicities, genders, and experiences. The FDA hopes to improve the safety and effectiveness of these devices for everyone, regardless of their background. This means considering how these products might impact people differently based on factors like race, ethnicity, gender, and more, so they can be used safely and effectively by all. These also include multiple geographic site selection consideration to perform clinical research studies in design of the clinical trial for both IVD and medical devices development.
[YW]: FDA's eSTAR program is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device premarket submission. It is intended to enhance the quality of submissions for a wide range of medical devices and IVD products. It is helping to ensure submitters provide quality, comprehensive data for premarket review. With a standardized format, submitters can ensure their submissions are complete, and FDA can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices. As of October 1, 2023, all 510(k) submissions must be submitted using eSTAR through the CDRH/FDA Portal.
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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.