FDA Org Structure & Regulatory Approval Process & EU MDR
The current Commissioner of the FDA
Who is Martin Makary, MD
Medical Device Reports are often provided to the FDA using MedWatch Form #
3500A
The codification of rules published in the Federal Register is documented in the
CFR (Code of the Federal Regulations)
The term used to describe the process of tracking all your components during manufacturing so that you can identify what components are used in each device?
What is traceability?
DHR stands for what?
Design history record?
The year that the Medical Device Amendments were passed, amending the FD&C Act.
What is 1976?
True or False. A manufacturer must get permission from the FDA prior to initiating a recall action.
False.
When (month and year) is the harmonization of 21 CFR 820 changing from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR)?
February 2026
P1 in Risk Management
What is the probability of a hazardous situation occurring (P2 is the probability the hazardous situation leads to harm)
Water, heat, fire (one from the list is fine).
The typical timeline for a Special 510(k) application to be cleared.
What is 30 days?
The FDA database for searching product event types including medical device reports (MDRs) of adverse events involving medical devices over the last ten years
What is MAUDE (Manufacturer and User Facility Device Experience) Database?
The section # of ISO 13485 titled "Design and development outputs."
What is 7.3.4?
Manufacturers must establish and maintain what to ensure that all purchased or otherwise received product and services conform to specifications.
What are procedures?
Which type of record is analogous to the recipe for making a device, comprising a compilation of records, procedures and specifications used to manufacture a device?
What is the Device Master Record (DMR)?
True or False. FDA does not have any jurisdiction outside the US, therefore they do not conduct inspections at foreign locations.
False. FDA can inspect manufacturers of products that are distributed in the US.
Manuf reporting requirements of deaths & SIs that a device may have cause or contributed to (for any employee becoming aware of an event) have this # of calendar days to report?
What is 30 days? (803.50)
Under 803.53, events that require remedial action to prevent an unreasonable risk of substantial harm to the public health and other types of events must report in 5 work days from becoming aware. Under 803.30, deaths & SIs from user facilities must reported w/in 10 working days to FDA and manufacturer (SIs to FDA is manuf unknown).
Action taken to eliminate a cause (after event) to prevent recurrence
What is a corrective action?
A correction is immediate at time; a preventive action stops from happening (before event)
These requirements describe what the device does while these requirements describe how well the device performs.
What are functional and performance?
These types of reports should be monitored for trends, and to see if any contain complaints.
What are service reports?
The European regulatory entity that is most analogous to the US FDA.
What is a Competent authority?
Addresses a problem with a medical device in the place where it is used or sold
What is a Correction?
A removal addresses a problem by removing it from where it is used or sold.
What is truthfully?
Never mislead, if you don't know the answer, ensure you state that and that you'll find the correct answer. Consult with your Quality Systems & Compliance team for additional best practices responding to FDA.
One of the processes required to ensure that measuring and test equipment continue to operate within specification.
What are calibration, inspection or maintenance processes? (will accept any of the 3 for answers)
This section of the CFR is new as part of the QMSR, and includes details on labeling and packaging inspections.
What is 21 CFR 820.45?