Successfully bringing a medical device to market in the United States requires careful adherence to FDA regulations to ensure compliance, patient safety, and operational efficiency. At Realistic Quality Solutions, we provide a strategic, results-driven approach to navigating regulatory complexities, minimizing delays, and streamlining marketing clearances and approvals across multiple FDA submission pathways.
Pathways Include:
513(g) Request – Determining Device Classification
FDA classification determination requests help businesses verify compliance requirements before investing in testing or submission efforts.
FDA Pre-Submission Meetings – Strategic FDA Engagement
Direct FDA interaction before submitting regulatory documentation can accelerate marketing clearances and approvals and resolve potential roadblocks early.
De Novo Request – Novel Medical Device Classification
A De Novo classification request can establish a new regulatory category for devices that lack a suitable predicate while demonstrating safety and effectiveness through risk-based evidence.
510(k) Submission – Substantial Equivalence & Market Entry
Most commercially available medical devices require 510(k) clearance, demonstrating that a new device is substantially equivalent to a legally marketed predicate device. Our team provides end-to-end support for this submission activity.
Premarket Approval (PMA) – High-Risk Medical Devices
Class III devices pose higher risks and require scientific validation through clinical trials and robust technical documentation. Our team also provides end-to-end support for this submission activity.
Comprehensive Regulatory Support
We ensure all required documentation meets FDA formatting, testing, and submission standards. Our FDA engagement experts streamline communications, and with the rise of digital health technologies, cybersecurity compliance plays a critical role in FDA marketing clearances and approvals. Medical devices require ongoing regulatory vigilance even after clearance or approval. We can assist with your Post-Market Compliance & Lifecycle Management activities.
With our deep expertise in FDA regulations, cybersecurity frameworks, and quality assurance, we help manufacturers accelerate clearances and approvals, reduce compliance risks, and achieve sustainable regulatory success. Ready to streamline your FDA marketing submission and secure market clearance or approval? Let’s collaborate on a regulatory roadmap for your medical device.