IVD Training

Technology

100

Gold standard for infectious disease

Culture

200

Gold standard for oncology

Pathology slides

300

What does LFA stand for?

Lateral Flow Assay

400

What is an IFU?

Instructions for Use - describes a product's Intended Use, how a sample is collected, tested, and results are viewed

COVID

100

How many positives are needed for EUA approval?

30

200

What is the current US COVID prevalence rate?

2.2%

300

What does EUA stand for?

Emergency Use Authorization

400

How long does it take NAMSA to run an EUA study?

4 months

Clinical

100

What is NAMSA's preferred EDC system?

iMedNet

200

Describe what POC and OTC user environments mean

POC-point of care-product is used right where patient is located, i.e. in ER, at urgent care, in battlefield

OTC-over the counter; at-home use; i.e. purchased at CVS

300

What is a usability study?

Study used to demonstrate product is safe and easy to use, and does not cause harm to user

400

What types of studies is NAMSA unable to support? 

Analytical validation

Pre-clinical

Feasibility

Verification and Validation

Reg

100

How much does NAMSA's pre-sub support cost?

$20K

200

What does NB stand for?

Notified Body

300

How many Notified Bodies have IVDR designation?

6

400

What is the regulatory body in China?

NMPA