Controls

Types of Controls

General Controls
     • Adulteration/misbranding
     • Electronic establishment registration
     • Electronic device listing
     • Quality systems
     • Labeling
     • Medical device reporting (MDR)

Special Controls
     • Guidelines (device manuals)
     • Mandatory performance standards
     • Recommendations or other actions
     • Special labeling
     • Guidance documents

Premarket Notification (510k)
     • Marketing clearing process
     • Demonstration of “substantial equivalence” Required when:
     • Marketing for the first time
     • Significant change to existing device that can affect safety and effectiveness (S&E)

Premarket Approval (510k)
PMA is the most stringent type of device marketing application required by FDA reserved for Class III or de novo devices. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).