Post-Market Requirements Flashcards
What is Medical Device Reporting (MDR) according to 21 CFR Part 803?
MDR is a mechanism for FDA to receive significant medical device adverse events from manufacturers, importers, and user facilities, to identify and monitor significant adverse events involving medical devices. It helps detect and correct problems in a timely manner.
What events must be reported under MDR regulations?
Manufacturers must report device-related deaths, serious injuries, and malfunctions that would likely cause or contribute to a death or serious injury if they were to recur. Importers must report deaths and serious injuries to both FDA and manufacturers, and malfunctions to manufacturers only.
What are the timeframes for MDR reporting?
Manufacturers must report deaths, serious injuries, and malfunctions within 30 calendar days of becoming aware of the event. Events requiring remedial action to prevent unreasonable risk of substantial harm to public health must be reported within 5 working days (5-day reports).
What is a correction versus a removal in the context of medical devices?
A correction is a repair, modification, adjustment, relabeling, destruction, or inspection of a device without physically removing it from its point of use. A removal is the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
When must a manufacturer report a correction or removal to FDA?
A manufacturer must report to FDA any correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health. Reports must be submitted within 10 working days of initiating the correction or removal.
What are the three classes of recalls and how do they differ?
Class I: Reasonable probability of serious adverse health consequences or death
Class II: May cause temporary or medically reversible adverse health consequences, or remote probability of serious adverse health consequences
Class III: Not likely to cause adverse health consequences
Describe post-market surveillance requirements under 21 CFR Part 822
Under 21 CFR Part 822, FDA can order post-market surveillance for certain Class II or III devices that are permanently implanted, life-sustaining/supporting, or pose serious health consequences. The surveillance plan must address study objectives, design, data collection, and reporting schedule.
What is the difference between a complaint and an MDR reportable event?
A complaint is any written, electronic, or oral communication that alleges deficiencies related to a device’s identity, quality, durability, reliability, safety, effectiveness, or performance. An MDR reportable event is specifically a death, serious injury, or malfunction that would be likely to cause or contribute to a death or serious injury if it were to recur.
What is the purpose of a Device Tracking System?
A device tracking system enables manufacturers to promptly locate devices and notify the appropriate persons when there is a recall or other safety issue. It’s required for certain Class II and III devices, including life-sustaining/supporting devices used outside a facility and permanently implantable devices.
What is the role of real-world evidence (RWE) in post-market surveillance?
RWE derived from real-world data (RWD) can complement traditional post-market surveillance by providing insights on device performance in actual use conditions across broader populations. It can be used to identify safety signals, expand indications, fulfill post-approval study requirements, and support regulatory decision-making.
