11.1 FDA Regulatory Process and Medical Device Classification

The FDA's regulatory process for medical devices is crucial for ensuring patient safety and product effectiveness. It involves classifying devices into risk-based categories, from low-risk Class I to high-risk Class III, each with specific regulatory requirements and controls.

Premarket requirements vary based on device classification. The 510(k) process applies to most moderate-risk devices, while high-risk devices undergo the more rigorous Premarket Approval (PMA) process. Alternative pathways exist for unique situations, like the De Novo classification for novel devices.

FDA Regulatory Process

FDA Overview and Medical Device Classification

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• Food and Drug Administration (FDA) oversees medical device regulation in the United States
• FDA's Center for Devices and Radiological Health (CDRH) responsible for device evaluation and approval
• Medical Device Classification system categorizes devices based on risk level and regulatory controls needed
• Class I devices pose lowest risk (bandages, tongue depressors)
  • Subject to general controls
  • Most exempt from premarket notification
• Class II devices pose moderate risk (powered wheelchairs, infusion pumps)
  • Subject to general and special controls
  • Usually require premarket notification
• Class III devices pose highest risk (implantable pacemakers, breast implants)
  • Subject to general controls and premarket approval
  • Require clinical data for safety and effectiveness

Device Registration and Post-Market Surveillance

• Device Registration and Listing process requires manufacturers to register their establishments
• Manufacturers must list all devices they produce or distribute
• Annual registration renewal mandatory for continued compliance
• Post-Market Surveillance monitors device performance and safety after market release
• Includes adverse event reporting through MedWatch program
• Manufacturers required to submit Medical Device Reports (MDRs) for serious adverse events
• FDA conducts inspections of manufacturing facilities to ensure compliance with quality system regulations
• Post-approval studies may be required for certain high-risk devices

Premarket Requirements

Premarket Notification (510(k)) Process

• 510(k) submission demonstrates device is substantially equivalent to a legally marketed predicate device
• Applies to most Class II and some Class I devices
• Submission includes device description, intended use, and performance data
• FDA review typically takes 90 days
• Clearance allows device to be legally marketed in the US
• Special 510(k) program for certain device modifications
• Abbreviated 510(k) program for devices with established performance criteria

Premarket Approval (PMA) and De Novo Classification

• Premarket Approval (PMA) required for Class III devices
• PMA process more rigorous than 510(k), involves clinical trials
• Submission includes comprehensive scientific and regulatory documentation
• FDA review typically takes 180 days, may include advisory panel review
• Approval based on demonstration of safety and effectiveness
• De Novo Classification pathway for novel devices without predicates
• Allows low to moderate risk devices to enter market without PMA
• De Novo review considers device risk profile and proposed controls

Substantial Equivalence and Alternative Pathways

• Substantial Equivalence determination compares new device to predicate
• Considers intended use, technological characteristics, and performance data
• Device can be substantially equivalent even with different technological characteristics if equally safe and effective
• Humanitarian Device Exemption (HDE) pathway for rare disease devices
• Custom Device Exemption for devices designed for specific patients
• Emergency Use Authorization (EUA) for devices during public health emergencies (COVID-19 tests)