The Regulatory Process for Medical Device Approval

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

Chemistry (correct)

Microbiology

Anesthesiology

Hematology

What is the regulatory class for companion diagnostics?

Class 4

Class 3 (correct)

Class 1

Class 2

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

Food Drug & Cosmetic Act

Federal Food, Drug, and Cosmetics Act (correct)

Federal Meat Inspection Act

Pure Food & Drug Act

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

Overseeing the safety of food, drug, and cosmetic products Signup and view all the answers

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

Center for Devices and Radiological Health Signup and view all the answers

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

Class 3 Signup and view all the answers

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 Signup and view all the answers

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

55% Signup and view all the answers

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

CT scanner Signup and view all the answers

Which of the following best describes a medical device?

An instrument used to diagnose diseases Signup and view all the answers

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

CT scanner Signup and view all the answers

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

Section 2: Medical Device Regulation Signup and view all the answers

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

De Novo 510(k) Signup and view all the answers

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

Less expensive regulatory fees Signup and view all the answers

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

Safety trials only Signup and view all the answers

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

Code of Federal Regulations Signup and view all the answers

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

Class I Signup and view all the answers

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

Class III Signup and view all the answers

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

Class I Signup and view all the answers

Which type of medical device requires biocompatibility testing?

Class II Signup and view all the answers

Which country first introduced Good Laboratory Practices (GLP)?

Denmark Signup and view all the answers

GLPs apply to which type of studies?

Nonclinical studies Signup and view all the answers

What is the purpose of GLPs?

To ensure high-quality data in nonclinical studies Signup and view all the answers

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

Good Laboratory Practices (GLP) Signup and view all the answers

What do GLPs require in terms of laboratory management?

Strict control of laboratory maintenance, operations, and training Signup and view all the answers

What do GLPs require in terms of the laboratory environment?

SOPs for cleaning and testing cleanliness and sterility Signup and view all the answers

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

Class 3 Signup and view all the answers

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

Class 3 Signup and view all the answers

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

To establish substantial equivalence to a predicate device Signup and view all the answers

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 Signup and view all the answers

The Regulatory Process for Medical Device Approval

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Questions and Answers

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?

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