Our glossary for guidance - Letter F

The failure rate provides an objective measure of the reliability of a system by determining the number of failures - related to a specific type of failure and within a defined period of time.

A result where the device incorrectly indicates that the specimen tested negative for the condition, attribute or property under analysis.

[Definition according to MDCG 2022-2 No. 4]

‘Falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

[Definition under (EU) 2017/745 Article 2 No. 9 also corresponds to definition under (EU) 2017/746 Article 2 No. 10]

The fault record card uses attributive tests, i.e. only the number of faulty parts is recorded on the fault record card (no measured values). Thus, only an evaluation of the number of defects can be given.

First-Come First-Served storage method refers to a possible structure within a queue of goods or documents.

FDA is the abbreviation for the US Food and Drug Administration. It controls the safety and efficacy of human and veterinary medicines, biological and medical products, food and radiation-emitting devices. This applies to products produced in the USA as well as imported products.

‘Field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

[Definition under (EU) 2017/745 Article 2 No. 68 also corresponds to definition under (EU) 2017/746 Article 2 No. 71]

‘Field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

[Definition under (EU) 2017/745 Article 2 No. 69 also corresponds to definition under (EU) 2017/746 Article 2 No. 72]

First In – First Out refers to a possible structure within a queue of goods or documents.

Is a device intended to be used to detect a marker or analyte  and which may be followed by a confirmatory assay. Devices intended to be used solely to monitor a previously determined marker or analyte are not considered first-line assays.

[Definition according to MDCG 2020-16 rev.1 No. 2]

FMEA stands for Failure Mode and Effects Analysis. Like FMECA (Failure Mode and Effecty Critical Analysis), FMEA is an analytical method (reliability technique) for identifying potential weaknesses, evaluating them and introducing appropriate measures, as well as evaluating them until they are within the tolerance range.

The formal principle is applied in project management to translate imponderables and risks into calculable processes.

An unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth.
Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

[Definition according to MDCG 2020-16 rev.1 No. 2]

FPA is an acronym for "First / Internal Party Audit".

First Passed Yield = Rolled Throughput Yield

Shortcut for Field Safety Corrective Action.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for Field Safety Notice.

[Definition of terms according to MDCG 2019-9 Abbreviations]

‘Fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device.

[Definition under (EU) 2017/745 Article 2 No. 31 also corresponds to definition under (EU) 2017/746 Article 2 No. 24]