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

September 19, 2014 10:15am


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

Gael Diane Tisack
Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property
Terumo Medical Corporation (Ann Arbor, MI)

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?