Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns

March 11, 2015 9:00am

Jennifer L. Bragg
Skadden, Arps, Slate, Meagher & Flom LLP

Seth A. Mailhot
Michael Best & Friedrich LLP (Washington, DC)

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?