Do you live in the US and are related to the medical field? If yes, this US medical device regulations quiz will be very helpful to you. The Medical Device Regulation (MDR) works on the legal framework for medical devices and introduces new principal and supportive responsibilities in the assessment of certain categories of products. These questions will expand your knowledge in terms of medical device regulations and how they work. Let's go!
Regulation number
Product code
Classification
Submission type (regulatory pathway)
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Market comparator device
Placebo device
Predicate device
Substantially equivalent device
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Class I
Class II
Class III
Class IV
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Document the change in the Device Master Record
Obtain FDA approval before implementing the change
Verify or validate the change before implementing
Review and approve the change according to an established design change procedure
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Providing evidence that the Design Controls procedures were followed
Recording results of clinical trials
Archiving results of customer complaints
Documenting verification of sterilization testing
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Affects the structure of the human body.
Cures or prevents disease in humans or animals.
Achieves its effect through chemical action on the human body.
Is recognized by the United States Pharmacopoeia.
Corrective and Preventive Action procedures are used during clinical studies to collect adverse effects information.
Corrective and Preventive Action deficiencies are one of the most frequently cited problems in FDA warning letters to manufacturers.
Corrective and Preventive Action procedures involve investigating potential product quality problems.
Changes identified as part of the Corrective and Preventive Action procedures should be verified or validated before implementation.
Feasibility
Product Development
Product Validation
Product Verification
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Study protocol
Investigational Device Exemption approval
Informed consent
Institutional Review Board approval
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Pay FDA a User fee.
Submit a 510(k) application to a third-party reviewer.
Complete the facility registration and device listing prior to 510(k) submission.
Include a cost-effectiveness analysis with the 510(k) submission.
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Study results can be used to establish device safety.
Institutional Review Board approval is required before starting a study.
Studies can be used to evaluate device concepts and refine a study protocol.
Study data can be used to manage patient care.
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Design reviews and/or phase reviews are required prior to market launch.
Manufacturers must monitor the performance of their devices following the market launch and make corrections as needed.
Changes to design input after market launch require FDA approval.
Clinical studies should be conducted with prototypes manufactured using methods and procedures expected to be used for ongoing production.
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FDA usually inspects a manufacturer’s facility prior to granting 510(k) clearance.
FDA requires clinical data with all 510(k) submissions.
All class II devices require 510(k) clearance.
The de novo pathway provides a route to 510(k) clearance for low and moderate-risk new devices.
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Conducting laboratory studies to understand new technologies
Changing design input requirements
Building non-clinical prototype devices
Collecting human study data
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During testing in support of future human studies
Upon deciding to develop a commercial product and approving product requirements (design input)
During studies to demonstrate proof of concept.
While validating a manufacturing process
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Good manufacturing practices
Substantial equivalence
Clinical study requirements
Design controls
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FDA guidance documents
Patient registries
Misbranding
Performance standards
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Special 510(k)
Abbreviated 510(k)
Traditional 510(k)
PMA
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Risk analysis
Validation testing
Design reviews
Design input
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