Podcast
Questions and Answers
Which federal agency is responsible for oversight of Medicare and Medicaid?
Which federal agency is responsible for oversight of Medicare and Medicaid?
- HHS
- HIPAA
- CMS (correct)
- FDA
What is the main focus of the FDA?
What is the main focus of the FDA?
- Approval
- Reimbursement
- Safety (correct)
- Surveillance
What type of test is described as a laboratory-developed test (LDT)?
What type of test is described as a laboratory-developed test (LDT)?
- Home brew test
- In Vitro Diagnostic (IVD)
- Commercial test
- DNA analysis (correct)
Which regulatory pathway is followed for clinical laboratories that will send samples to a single lab for testing?
Which regulatory pathway is followed for clinical laboratories that will send samples to a single lab for testing?
Which class of diagnostic tests requires the highest level of regulatory oversight?
Which class of diagnostic tests requires the highest level of regulatory oversight?
What type of diagnostic tests are routine tests like the determination of cholesterol and the urine home pregnancy test?
What type of diagnostic tests are routine tests like the determination of cholesterol and the urine home pregnancy test?
Which regulatory pathway requires substantial equivalence to a predicate diagnostic for approval?
Which regulatory pathway requires substantial equivalence to a predicate diagnostic for approval?
What is the average time to approval for class 2 diagnostics through the 510(k) regulatory pathway?
What is the average time to approval for class 2 diagnostics through the 510(k) regulatory pathway?
Which regulatory agency sets reimbursement rates for Medicare and Medicaid?
Which regulatory agency sets reimbursement rates for Medicare and Medicaid?
What is the purpose of analyte-specific reagents?
What is the purpose of analyte-specific reagents?
What is the advantage of Laboratory Developed Tests (LDTs)?
What is the advantage of Laboratory Developed Tests (LDTs)?
Which regulatory agency oversees and regulates medical or CLIA labs?
Which regulatory agency oversees and regulates medical or CLIA labs?
Which pathway is the preferred route for diagnostics that lack a clear predicate device?
Which pathway is the preferred route for diagnostics that lack a clear predicate device?
What is the range of submission fees for the de novo 510(k) pathway?
What is the range of submission fees for the de novo 510(k) pathway?
What is the range of development costs for the PMA pathway?
What is the range of development costs for the PMA pathway?
What is the range of approval time for the PMA pathway?
What is the range of approval time for the PMA pathway?
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?
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?
What is the purpose of the Oncotype DX test from Genomic Health?
What is the purpose of the Oncotype DX test from Genomic Health?
Which division within the FDA's Office of In Vitro Diagnostics and Radiological Health evaluates diagnostic tests related to chemistry and toxicology?
Which division within the FDA's Office of In Vitro Diagnostics and Radiological Health evaluates diagnostic tests related to chemistry and toxicology?
Which of the following statements about Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) is correct?
Which of the following statements about Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) is correct?
Which of the following best describes the difference between an In Vitro Diagnostic (IVD) and a Laboratory Developed Test (LDT)?
Which of the following best describes the difference between an In Vitro Diagnostic (IVD) and a Laboratory Developed Test (LDT)?
Which of the following best describes the differences in approval for IVDs and LDTs?
Which of the following best describes the differences in approval for IVDs and LDTs?
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)?
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)?
Which of the following best describes the importance of diagnostics in medicine?
Which of the following best describes the importance of diagnostics in medicine?
Which of the following is an example of an internal control in a clinical laboratory?
Which of the following is an example of an internal control in a clinical laboratory?
What is the purpose of running external controls in a clinical laboratory?
What is the purpose of running external controls in a clinical laboratory?
What type of diagnostics must be developed, tested, and manufactured following quality system regulations?
What type of diagnostics must be developed, tested, and manufactured following quality system regulations?
What is the purpose of a complaint-handling system in a diagnostic test manufacturer?
What is the purpose of a complaint-handling system in a diagnostic test manufacturer?
What are the requirements for labeling and registration of a diagnostic test with the FDA?
What are the requirements for labeling and registration of a diagnostic test with the FDA?
Are the requirements for the complaint-handling system and medical device reporting the same for devices and diagnostics?
Are the requirements for the complaint-handling system and medical device reporting the same for devices and diagnostics?
