The Regulatory Process for Medical Device Approval

Which category of medical devices includes products used in the chemical analysis of samples?

What is the regulatory class for companion diagnostics?

Which act replaced the Pure Food & Drug Act in 1938?

What is the FDA's role in medical device regulation?

Which department within the FDA is responsible for regulating medical devices?

Which class of medical devices has the highest risk to the patient?

Which amendment to the FD&C Act introduced the regulation of medical devices as class 1, 2, or 3 devices?

What percentage of all medical devices are classified as Class 1?

Which one of the following is NOT considered a medical device according to the FDA?

Which of the following best describes a medical device?

Which of the following is an example of a diagnostic medical device?

Which section of the course will discuss medical device regulation and approval?

Which pathway is preferred if a medical device does not have a substantially equivalent predicate device?

What is the advantage of the de novo 510(k) pathway over the PMA pathway?

What type of clinical trials are required for a medical device undergoing the de novo 510(k) pathway?

Which regulatory statutes govern the manufacture and testing of medical devices in the United States?

Which type of medical device requires the lowest level of regulatory oversight?

Which type of medical device carries the greatest risk to the patient?

Which type of medical device is likely to be easily detected if it malfunctions?

Which type of medical device requires biocompatibility testing?

Which country first introduced Good Laboratory Practices (GLP)?

GLPs apply to which type of studies?

What is the purpose of GLPs?

What does the saying 'If you didn't write it down... you didn't do it' refer to?

What do GLPs require in terms of laboratory management?

What do GLPs require in terms of the laboratory environment?

Which class of medical devices must go through premarket approval, including extensive clinical trials and facility inspection?

Which class of medical devices requires facility inspection prior to product launch?

What is the purpose of the 510(k) procedure for class 2 medical devices?

What is a predicate device in the context of the 510(k) premarket notification process?