30 Questions
Which federal agency is responsible for oversight of Medicare and Medicaid?
CMS
What is the main focus of the FDA?
Safety
What type of test is described as a laboratory-developed test (LDT)?
DNA analysis
Which regulatory pathway is followed for clinical laboratories that will send samples to a single lab for testing?
CLIA pathway
Which class of diagnostic tests requires the highest level of regulatory oversight?
Class 3
What type of diagnostic tests are routine tests like the determination of cholesterol and the urine home pregnancy test?
Class 1 diagnostics
Which regulatory pathway requires substantial equivalence to a predicate diagnostic for approval?
510(k) regulatory pathway
What is the average time to approval for class 2 diagnostics through the 510(k) regulatory pathway?
6 months
Which regulatory agency sets reimbursement rates for Medicare and Medicaid?
CMS
What is the purpose of analyte-specific reagents?
To identify and measure the amount of a specific substance in a sample
What is the advantage of Laboratory Developed Tests (LDTs)?
They do not require FDA approval
Which regulatory agency oversees and regulates medical or CLIA labs?
CMS
Which pathway is the preferred route for diagnostics that lack a clear predicate device?
De novo 510(k) pathway
What is the range of submission fees for the de novo 510(k) pathway?
$100,000 - $200,000
What is the range of development costs for the PMA pathway?
$100 million - $200 million
What is the range of approval time for the PMA pathway?
7-9 months
Which prenatal test detects fetal DNA in the mother's blood to test for Down's Syndrome and can also detect excess chromosomes 13 and 18?
MaterniT21
What is the purpose of the Oncotype DX test from Genomic Health?
To calculate the risk of breast cancer recurrence
Which division within the FDA's Office of In Vitro Diagnostics and Radiological Health evaluates diagnostic tests related to chemistry and toxicology?
Division of Chemistry and Toxicology
Which of the following statements about Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) is correct?
LDTs must be approved by the FDA, while IVDs can be self-approved by the lab that created the diagnostic.
Which of the following best describes the difference between an In Vitro Diagnostic (IVD) and a Laboratory Developed Test (LDT)?
An IVD is a test developed by a single laboratory, while an LDT is a test developed by multiple commercial laboratories.
Which of the following best describes the differences in approval for IVDs and LDTs?
IVDs require regulatory approval, while LDTs do not require regulatory approval.
Which of the following best describes the differences in oversight for the Center of Medicare and Medical Services (CMS) with the Food and Drug Administration (FDA)?
CMS oversees the approval process for LDTs, while FDA oversees the approval process for IVDs.
Which of the following best describes the importance of diagnostics in medicine?
Diagnostics are critical for accurate disease diagnosis, treatment decisions, and patient management.
Which of the following is an example of an internal control in a clinical laboratory?
Ensuring a reliable power supply
What is the purpose of running external controls in a clinical laboratory?
To verify test accuracy, sensitivity, and specificity
What type of diagnostics must be developed, tested, and manufactured following quality system regulations?
All diagnostics
What is the purpose of a complaint-handling system in a diagnostic test manufacturer?
To process medical device reporting
What are the requirements for labeling and registration of a diagnostic test with the FDA?
All diagnostics
Are the requirements for the complaint-handling system and medical device reporting the same for devices and diagnostics?
Yes, they are the same
N/A
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