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Navigating the complex landscape of FDA approval for medical devices can be daunting. At Vigilare Biopharma, we specialize in guiding companies through every step of this process, ensuring that your medical device meets all regulatory requirements and reaches the market efficiently.
The first step to FDA approval is accurately classifying your device and determining the appropriate regulatory pathway. Whether your device falls under Class I, II, or III, we help you identify whether a 510(k) submission, Premarket Approval (PMA), De Novo classification, or another pathway is necessary. This crucial step sets the foundation for a smooth approval process.
Before you submit your application, we provide Pre-Submission (Pre-Sub) support to gather feedback from the FDA. Our experts help draft and review your Pre-Sub package, ensuring that your regulatory strategy, clinical study protocols, and other key documents align with FDA expectations. Early feedback from the FDA can significantly increase the chances of a successful submission.
Our team coordinates all necessary bench testing, animal studies, and clinical trials, ensuring they meet FDA standards. We manage the entire process, from protocol development to data collection, analysis, and reporting. If an Investigational Device Exemption (IDE) is needed, we handle the submission to allow your clinical trials to proceed in the U.S.
Preparing a 510(k), PMA, or De Novo application involves compiling extensive documentation. Vigilare Biopharma takes the lead in assembling, reviewing, and submitting your application. We ensure that your submission includes all required information, such as device descriptions, substantial equivalence claims, labeling, and clinical data.
Once your application is submitted, we act as your primary point of contact with the FDA. We respond promptly to any questions or requests for additional information, providing the FDA with everything they need to evaluate your device. Our goal is to facilitate a smooth and efficient review process, reducing delays and increasing the likelihood of approval.
After your device is approved or cleared, Vigilare Biopharma continues to support you in meeting post-market requirements. We assist with labeling and advertising compliance, post-market surveillance, and maintaining Quality System Regulation (QSR) standards. Our ongoing support ensures that your device remains compliant throughout its lifecycle.
We help you list your device with the FDA and register your manufacturing facility, completing the final steps to market entry. Vigilare Biopharma also offers continuous compliance services, including monitoring regulatory changes, managing adverse event reporting, and preparing for FDA inspections.
Our deep expertise in FDA regulations, combined with our hands-on approach, allows us to provide unparalleled support throughout the FDA approval process. We understand the unique challenges medical device companies face, and we are committed to helping you bring safe and effective products to market as efficiently as possible.
This comprehensive approach ensures that you have a partner at every stage of the FDA approval process, from initial classification to post-market compliance. With Vigilare Biopharma by your side, you can focus on innovation while we handle the regulatory complexities.
