Devices & Diagnostics

Medical devices and diagnostics: the 510(k) and PMA pathways, ISO 13485, design controls and the Design History File, UDI, biocompatibility, and assay sensitivity and specificity.

Key terms & definitions

16 terms in this pack

ANALYTE

The substance a diagnostic test actually measures

BIOCOMPATIBILITY

Whether device materials are safe in contact with the body (ISO 10993)

CEMARK

EU conformity symbol letting a device be sold in Europe (two words)

CLEARANCE

FDA go-ahead for a moderate-risk device via the 510(k) pathway

CLIA

U.S. law regulating the quality of clinical laboratory testing (acronym)

DENOVO

Pathway for a novel low-to-moderate-risk device with no predicate

DESIGNCONTROL

Procedures ensuring a device is safe and meets user needs (two words)

DHF

Design History File documenting a device's development (acronym)

EQUIVALENCE

Substantial ___: the 510(k) standard versus a predicate device

INTENDEDUSE

The official statement of what a device is for (two words)

PMA

Premarket Approval, the strict pathway for high-risk Class III devices (acronym)

PREDICATE

An existing device a 510(k) shows you're substantially equivalent to

SENSITIVITY

A diagnostic's ability to correctly catch true positives

SPECIFICITY

A diagnostic's ability to correctly rule out true negatives

UDI

Unique Device Identification code that tracks devices in the supply chain (acronym)

VERIFICATION

Design check confirming outputs meet the input requirements