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