A De Novo grant classifies your device and sets ongoing obligations. Stay compliant with special controls, postmarket requirements, and monitor FDA references to maintain quality and anticipate competitive dynamics.
A De Novo grant classifies your device type into Class I or II and often establishes special controls in regulation. From that moment, you are responsible for complying with all applicable postmarket requirements, including Quality Management Systems (QMS), Medical Device Reporting (MDR), corrections and removals, Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) submissions, and any device-specific controls. Additionally, your device can serve as a predicate for future 510(k) submissions.
Treat the special controls as ongoing obligations by:
Monitor FDA’s database for subsequent 510(k) submissions referencing your device to anticipate competitive dynamics. Reviewing Class II special controls patterns helps you anticipate FDA’s expectations for ongoing maintenance.
If the FDA requires postmarket surveillance or additional controls, embed these activities into your postmarket surveillance (PMS) plan and management review cadence. When planning transitions to expanded indications, use Pre-Submission (QSub) meetings to confirm evidence needs and regulatory expectations.
