Quiz: US IVDs

Which regulatory pathway is typically used for IVDs that are low to moderate risk and have a predicate device on the market?

510(k) Clearance

Which of the following documents is typically required as part of a premarket submission for an IVD device in the US?

All of the above

Which of the following is a requirement for a premarket submission of an In Vitro Diagnostic (IVD) device in the United States?

All of the above

What does the term "IVD Companion Diagnostic" refer to?

An IVD device used alongside a specific therapeutic product

What role does the Clinical Laboratory Improvement Amendments (CLIA) play in regulating laboratory-developed tests (LDTs)?

CLIA establishes performance standards for LDTs

Who develops and uses Laboratory Developed Tests (LDTs)?

Clinical laboratories

What criteria does the FDA use to classify in vitro diagnostic devices (IVDs) in the United States?

Complexity of the device and intended use

Which regulatory pathway is often used for IVDs that introduce new technologies but are low to moderate risk with no predicate device?

De Novo classification

Which regulatory pathway typically applies to IVDs that are low to moderate risk and have no predicate device?

De Novo classification

Which regulatory agency oversees the approval and oversight of IVDs in the European Union?

EMA (European Medicines Agency)

True or False: ASRs (Analyte Specific Reagents) are complete diagnostic tests that can be used independently for patient diagnosis.

False

True or False: ASRs (Analyte Specific Reagents) are intended for clinical diagnostic use and can be marketed as standalone diagnostic tests.

False

True or False: Emergency Use Authorizations (EUAs) are typically granted to IVDs during public health emergencies without prior FDA review.

False

True or False: In the US, RUO (Research Use Only) IVDs can be legally marketed for clinical diagnostic purposes.

False

True or False: In vitro diagnostic devices (IVDs) do not require regulatory approval before they can be marketed in any country.

False

Which of the following statements about GPR (General Purpose Reagents) is true?

GPRs are versatile reagents that are used in various laboratory procedures

Which of the following is an example of a Point-of-Care (POC) IVD device?

Glucose meter used by diabetic patients

In what context would an IVD be labeled as "IUO"?

Investigational studies for clinical trials

Which of the following is a requirement for an IVD to be labeled as an ASR (Analyte Specific Reagent)?

It must be specific to a single analyte

What aspect of an IVD's performance is assessed during analytical validation?

Its ability to generate accurate and reliable results

Which of the following is an example of a molecular diagnostic in vitro diagnostic (IVD)?

PCR-based test for detecting genetic mutations

Which regulatory pathway is typically required for high-risk IVDs in the US that have no predicate device?

PMA (Pre-market Approval)

Which phase of clinical trials typically involves testing an IVD on a large group of patients to confirm its safety and efficacy?

Phase III

What is the primary intended use of an IVD labeled as "RUO"?

Research purposes only, not for clinical diagnostic use

What is the primary role of the FDA's Center for Devices and Radiological Health (CDRH) in the approval of IVD devices in the US?

Reviewing premarket submissions and issuing marketing approvals

Which regulatory agency oversees the approval of IVDs in Australia?

TGA (Therapeutic Goods Administration)

What is the primary difference between the "traditional" and "special" 510(k) pathways for IVD devices?

The traditional pathway requires clinical trial data, while the special pathway does not

During the FDA review process, what is the purpose of the pre-submission meeting for an IVD manufacturer?

To discuss regulatory requirements and submission strategy

What is the purpose of analytical validation for an IVD?

To ensure the accuracy and reliability of test results

What is the primary purpose of CLIA regulations in the United States?

To establish standards for clinical laboratory testing

What is the purpose of a 510(k) submission for an IVD device?

To obtain FDA clearance for marketing based on substantial equivalence

What is the primary purpose of a GPR (General Purpose Reagent) in laboratory testing?

To perform routine quality control checks

What is the primary purpose of a companion diagnostic IVD?

To predict patient response to a specific treatment

What is the primary goal of the pre-analytical phase in laboratory testing?

To prepare and handle clinical samples properly

What is the primary purpose of an ASR in the context of IVDs?

To quantify specific analytes in laboratory samples

True or False: LDTs (Laboratory Developed Tests) are exempt from FDA oversight under certain conditions.

True

True or False: LDTs (Laboratory Developed Tests) must comply with FDA regulations even if they are developed and used within a single laboratory.

True

True or False: The De Novo classification pathway can be used for IVD devices that are not substantially equivalent to any predicate device on the market.

True

True or False: The FDA's Breakthrough Device designation is primarily intended for IVD devices that offer significant advantages over existing alternatives for serious or life-threatening diseases.

True