Navigating Market Authorization
The pathway to medical device market authorization varies significantly by device classification, intended use, and target market. In the United States, FDA offers multiple routes—510(k), De Novo, and PMA.
RegOps provides end-to-end submission support across FDA pathways and international markets. We help you select optimal regulatory strategies, develop compliant submission packages, and navigate agency interactions throughout the review process. Our submission specialists combine regulatory knowledge with technical understanding to ensure your submissions address agency expectations accurately.
Our Capabilities
Comprehensive support for FDA and global regulatory submissions.
Complete 510(k) development including predicate selection strategy, substantial equivalence, performance testing protocols, and submission compilation for Traditional, Abbreviated, and Special 510(k)s.
Strategic support for novel devices without predicates. We help develop risk-based classification arguments, propose special controls, and prepare De Novo submissions for new device types.
Comprehensive Class III support from pre-submission strategy through approval. We assist with clinical study design, manufacturing documentation, and managing the review of safety and effectiveness data.
Development of Pre-Sub requests to elicit meaningful FDA feedback on regulatory pathway, testing strategies, clarity on clinical data requirements before committing to a submission.
Regulatory submission support for Health Canada, TGA, ANVISA, PMDA, NMPA, and other global authorities. We adapt US submissions to meet specific international requirements.
Support for 510(k) modifications, PMA supplements (panel-track, 180-day, real-time, 30-day), annual reports, and design change documentation to maintain authorization.
The RegOps Advantage
We've navigated hundreds of agency interactions and understand review dynamics across FDA divisions and international authorities.
Pathway Optimization
We evaluate all pathways to recommend approaches balancing time-to-market, evidentiary burden, and long-term flexibility.
Technical Integration
Our professionals work closely with engineering and clinical teams so submissions accurately reflect device design and performance.
Agency Relationships
We understand common deficiency themes and effective response strategies across various regulatory bodies.
Deficiency Prevention
Submissions are developed with the reviewer in mind, anticipating questions to facilitate efficient review and reduce RTA deficiencies.