FDA’s Risk-Based Classification Scheme

• Understanding the concept of risk-based classification
• Three main classes of medical devices
• Device reclassification

The Premarket Review Process

• Potential changes to 510(k) process and changes to diagnostics
• 510(k) exemptions for low risk devices and the role of the
• Investigational Device Exemption (IDE)
• Understanding the selection of “predicate” devices when 510(k) submissions are made and the consequences of choosing the wrong predicate
• Premarket approval (PMA) process

Post-Market Requirements and Concerns

• What is the scope of the Quality System Regulation (QSR)?
• What are the reporting requirements under the Medical Device
  Reporting (MDR) and Reports of Corrections and Removals regulations?
• What other types of post-market requirements can FDA impose on medical devices, e.g., tracking?
• What claims can device manufacturers make regarding cleared/ approved devices, devices with pending 510(k) notices, and investigational devices?
• What are the consequences of illegal promotion of a device?
• What medical device recalls need to be reported to FDA?
• FDA seizure and injunction power
• When can product be reintroduced to the market?