Medical Devices Flashcards
Class I Devices
Lowest risk and their safety is through adherence to general standards
Class II Devices
Moderate risk and must adhere to the general standards plus other standards set for the products in the class
Class III Devices
Either high risk or are new to FDA and without prior safety information
Premarket Notification 510(k)
A 510(k) determination indicates that FDA determined that the device is substantially equivalent to a device that was already allowed on the market. Occasionally no clinical experience is included in the evidence of substantial equivalence information sent to FDA for clearance and it can enter the market without prior clinical trials.
Premarket Approval (PMA)
The PMA route resembles the new drug application (NDA) for investigational drugs entering the market. It involves FDA review of all prior clinical investigation results to support the safety and effectiveness of the device.
SR Device
Significant Risk Device, must be under an IDE application
NSR Device
Non-significant Risk Device, abbreviated IDE regulatory requirements.
IDE Exempt Device
Does not include an invasive sampling procedure that is greater than minimal risk; Does not introduce energy into the subject; device will not be used in a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic produce of procedure.
HUD
Humanitarian Use Device: intended to benefit patients in the treatment or diagnosis of a disease or condition affecting fewer than 8000 individuals in US per year. Only safety, not efficacy evidence needs to be provided to the FDA.
ISO 14155:2020 GCP Standard
describes GCP for the ethical design, conduct, recording, and reporting of clinical investigations involving human subjects to assess the safety and performance of medical devices to meet regulatory requirements.
Does the FDA have jurisdiction over an EU trial
yes, if it is performed under an IDE
UP
Unanticipated problems
