30 Questions
Which category of medical devices includes products used in the chemical analysis of samples?
Chemistry
What is the regulatory class for companion diagnostics?
Class 3
Which act replaced the Pure Food & Drug Act in 1938?
Federal Food, Drug, and Cosmetics Act
What is the FDA's role in medical device regulation?
Overseeing the safety of food, drug, and cosmetic products
Which department within the FDA is responsible for regulating medical devices?
Center for Devices and Radiological Health
Which class of medical devices has the highest risk to the patient?
Class 3
Which amendment to the FD&C Act introduced the regulation of medical devices as class 1, 2, or 3 devices?
Medical Device Amendments of 1976
What percentage of all medical devices are classified as Class 1?
55%
Which one of the following is NOT considered a medical device according to the FDA?
CT scanner
Which of the following best describes a medical device?
An instrument used to diagnose diseases
Which of the following is an example of a diagnostic medical device?
CT scanner
Which section of the course will discuss medical device regulation and approval?
Section 2: Medical Device Regulation
Which pathway is preferred if a medical device does not have a substantially equivalent predicate device?
De Novo 510(k)
What is the advantage of the de novo 510(k) pathway over the PMA pathway?
Less expensive regulatory fees
What type of clinical trials are required for a medical device undergoing the de novo 510(k) pathway?
Safety trials only
Which regulatory statutes govern the manufacture and testing of medical devices in the United States?
Code of Federal Regulations
Which type of medical device requires the lowest level of regulatory oversight?
Class I
Which type of medical device carries the greatest risk to the patient?
Class III
Which type of medical device is likely to be easily detected if it malfunctions?
Class I
Which type of medical device requires biocompatibility testing?
Class II
Which country first introduced Good Laboratory Practices (GLP)?
Denmark
GLPs apply to which type of studies?
Nonclinical studies
What is the purpose of GLPs?
To ensure high-quality data in nonclinical studies
What does the saying 'If you didn't write it down... you didn't do it' refer to?
Good Laboratory Practices (GLP)
What do GLPs require in terms of laboratory management?
Strict control of laboratory maintenance, operations, and training
What do GLPs require in terms of the laboratory environment?
SOPs for cleaning and testing cleanliness and sterility
Which class of medical devices must go through premarket approval, including extensive clinical trials and facility inspection?
Class 3
Which class of medical devices requires facility inspection prior to product launch?
Class 3
What is the purpose of the 510(k) procedure for class 2 medical devices?
To establish substantial equivalence to a predicate device
What is a predicate device in the context of the 510(k) premarket notification process?
A medical device that is currently marketed in the United States
N/A
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