RAC Devices Core Exam Questions and Answers All Correct
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RAC Devices Core
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RAC Devices Core
RAC Devices Core Exam Questions and Answers All Correct
The Medical Device User Fee and Modernization Act of 2002 - Answer- authorized FDA to assess fees for the review of premarket submissions
The following changes were included in the 2007 amendment to the Medical Device Directives (2007...
RAC Devices Core Exam
Questions and Answers All
Correct
The Medical Device User Fee and Modernization Act of 2002 - Answer- authorized FDA
to assess fees for the review of premarket submissions
The following changes were included in the 2007 amendment to the Medical Device
Directives (2007/47/EC) - Answer- - additional clinical data requirements
- labeling requirements
custom-made device in Europe - Answer- a device intended for the sole use of a
particular patient
criteria that must be met for an item to be regulated as an accessory to a medical
device in Europe - Answer- the article itself is not a device
in vitro diagnostic med device - Answer- used to analyze body fluids to provide info for
diagnosis, prevention or treatment of disease in humans and animals
in vitro diagnostic med device 2/3 - Answer- used to monitor therapeutic measures
in vitro diagnostic med device 3/3 - Answer- intended for primary containment and
preservation of specimens derived from the human body for the purpose of in vitro
diagnostic examination
Country with the Quality Systems Regulation (21 CFR 820) - Answer- US
Key issues to consider when preparing a regulatory strategy - Answer- - competitor
products that are already marketed and use a similar technology
- The Target Product Profile
items to be considered to develop a clinical evaluation strategy - Answer- - predicate
devices
- literature data
- country specific requirements for data in local patients
- differing standard of care/use environments in different countries
, - existing clinical data generated with concerned device
regulation of devices in Japan - Answer- - for certain devices, licensing applications are
reviewed by an independent, authorized 3rd party
- the PMDA is the regulatory agency overseeing medical devices in Japan
- Medical devices are regulated under the Pharmaceutical and Medical Device Act
According to the _________ system, when one device is intended to be used along with
a "parent device" classification rules apply to each of the devices separately - Answer-
IMDRF/ GHTF
PMA in the US for a companion diagnostic would incude: - Answer- - information on the
manufacturer's compliance with a Quality Management System
- Good Laboratory Practice (GLP) compliance information for selected nonclinical
studies
- Instructions for Use
clinical assessments - Answer- some countries require manufactures to present clinical
data from local patients
EU Nonsterile Class 1 devices without measuring function - Answer- do not need to
undergo a formal conformity assessment by a Notified Body
The EU recognizes _______ different types of conformity assessment procedures -
Answer- three
once a ______ has been affixed, the medical device can circulate freely within the EU
common market - Answer- CE mark
key components for a license application - Answer- - evidence of safety and
performance
- labelling
According to the GHTF/IMDRF conformity assessment procedures: - Answer- Class A
devices usually do not require submission and premarket approval of the technical
dossier to the regulatory authority
IMDR/GHTF device classification, Class C devices include all of the following: - Answer-
- devices involved in blood grouping for the Rhesus system
- devices used in screening for selection of patients for selective therapy and
management as companion diagnostics
- devices determining infective disease status or immune status, and where there is risk
that an erroneous result will lead to a patient management decision resulting in an
imminent life-threatening situation
non-IVD medical devices - Answer- - degree of invasiveness
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