A De Novo grant often establishes special controls that define safety, effectiveness, and future 510(k)s. Propose objective, testable, enforceable controls tied to risks—turning your evidence strategy into a lasting competitive advantage.
A De Novo grant often creates (or updates) a regulation with special controls for your new device type. These controls—combined with general controls—set the bar for safety and effectiveness and shape future 510(k) submissions using your device as a predicate.
Strong special controls are:
They commonly include defined performance testing, labeling requirements, design verification, software assurance, biocompatibility, electrical safety and electromagnetic compatibility (EMC), shelf life, and sometimes postmarket surveillance triggers.
Review existing Class II special controls for patterns and language to guide your proposals
Propose controls that FDA can enforce and that you can demonstrate through testing or process controls. This approach hardcodes your risk-based strategy into the market standard, providing a competitive advantage and helping ensure ongoing compliance.
