Navigating FDA pre-market submissions requires deep knowledge of both the regulatory framework and the technical evidence standards. We prepare submissions that are complete, well-documented, and built to clear — not just filed and hoped for.
FDA pathway selection is one of the most consequential early decisions in device development. Choosing wrong adds 12–18 months and significant cost. We get it right from the start.
The most common pathway for Class II devices. Requires demonstrating substantial equivalence to a legally marketed predicate device. We identify the strongest predicate strategy, structure the SE argument, and manage the full submission lifecycle.
For novel Class II devices without an appropriate predicate. De Novo creates a new device classification and establishes the special controls future 510(k)s will reference. More rigorous than 510(k) but far less demanding than PMA.
Required for most Class III devices — implantable cardiac devices, neurological stimulators, high-risk diagnostics. Requires valid scientific evidence (typically clinical data) demonstrating safety and effectiveness. We build and manage the full PMA strategy.
From device classification analysis through FDA response management, we handle every component of a complete, first-time-ready FDA submission.
Definitive classification determination under 21 CFR Parts 862–892, product code identification, and pathway recommendation before any resources are committed.
Identification and analysis of the strongest predicate device(s) for a 510(k), including SE argument structure for intended use and technological characteristics.
Every section of the 510(k), De Novo, or PMA — device description, indications, substantial equivalence, performance testing, labeling, and eCopy — written and formatted to FDA standards.
If FDA issues an Additional Information (AI) request or deficiency letter, we respond fast and comprehensively — addressing each point with targeted technical evidence.
QMS design and implementation aligned to FDA's updated Part 820, which now incorporates ISO 13485. SOPs, design history files, CAPA, and complaint handling built submission-ready.
Most submission delays aren't caused by FDA review time — they're caused by incomplete or poorly structured submissions that trigger AI requests. We see the same issues repeatedly:
Our submissions are structured to anticipate and pre-empt every one of these. The goal is a single review cycle — not a deficiency letter followed by months of back-and-forth.
Book a free discovery call — we'll assess your device and recommend the right pathway and strategy.