RAC Device Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Humanitarian Use Device (HUD) - ANSWER a device that is intended to
benefit patients in the treatment or diagnosis of a disease or condition
affecting fewer than 8,000 individuals in the US per year
2. Implantable Medical Device (IMD) - ANSWER A medical device intended
to be wholly introduced into the body by surgical intervention and stay in
place; to replace an epithelial surface or the surface of an eye in a human
by surgical intervention and stay in place; or to be partially introduced into
the body by surgical intervention and remain in place for at least 30 days
after the procedure.
3. In Vitro Diagnostic Device (IVDD) - ANSWER Any medical device which is
a reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment, or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for the examination of
specimens. Also IVD and IVMD.
,4. In Vitro Diagnostic Devices Directive (IVDD) - ANSWER Directive
98/79/EC, Covers devices used in vitro to examine specimens derived from
the human body, including reagents, instruments and specimen receptacles.
5. In Vitro Diagnostic Medical Devices Regulation (IVDR) - ANSWER
Regulation (EU) 2017/746 of the European Parliament and of the Council on
in vitro diagnostic medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU. Also known as EU IVDR.
6. In Vitro Diagnostic Medical Device (IVD per EU IVDR) - ANSWER Any
medical device which is a reagent, reagent product, calibrator, control
material, kit, instrument, apparatus, equipment, or system, whether used
alone or in combination, intended by the manufacturer to be used in vitro
for the examination of specimens, including blood and tissue donations,
derived from the human body, solely or principally for the purpose of
providing information on a physiological or pathological process or state; a
congenital physical or mental impairments; the predisposition to a medical
condition or a disease; the safety and compatibility with potential
recipients; predicting treatment response or reactions; or defining or
monitoring therapeutic measures. Specimen receptacles are also in vitro
diagnostic medical devices.
7. In Vitro Diagnostic Medical Device (IVD) - ANSWER Any medical device
which is a reagent, reagent product, calibrator, control material, kit,
instrument, apparatus, equipment, or system, whether used alone or in
combination, intended by the manufacturer to be used in vitro for the
examination of specimens. Also IVDD.
,8. In Vitro Medical Device (IVMD) - ANSWER Any medical device which is a
reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment, or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for the examination of
specimens. Also IVD and IVDD.
9. Installation Qualification (IQ) - ANSWER A series of tests designed to
provide documentary evidence that the system has been built and installed
correctly and that all required supporting services and capacity, water and
compressed air systems of the required quality and capacity are available
and connected correctly.
10.Instructions for Use (IFU) - ANSWER Information provided by a device
manufacturer to inform the device user of the medical device's intended
purpose and proper use and of any precautions to be taken.
11.Intellectual Property (IP) - ANSWER Creations of the mind, including
inventions, literary and artistic works, and symbols, names, images, and
designs used in commerce.
12.Intellectual Property Rights (IPRs) - ANSWER The area of law that
regulates the ownership and use of creative works, including patent,
copyright, and trademark law. Intellectual property rights have been
developed to protect creative people who have disclosed their work for the
benefit of humankind from having it copied or imitated without their
consent.
, 13.International Medical Device Regulators Forum (IMDRF) - ANSWER Body
comprising representatives from the medical device regulatory authorities
of Australia, Brazil, Canada, China, EU, Japan, Russia, and US that provides
guidance on strategies, policies, and directions for international medical
device regulatory harmonization. Replaced GHTF.
14.International Organization for Standardization (ISO) - ANSWER A
network of 161 national standards institutes working in partnership with
international organizations, governments, industry, business and consumer
representatives, ISO develops worldwide industrial and commercial
standards.
15.Interoperability - ANSWER Ability of two or more products,
technologies, or systems, which may include medical devices, to exchange
information and use the information that has been exchanged.
Invasive device - ANSWER A device, which, in whole or in part, penetrates
inside the body, either through a body orifice or through the surface of the body.
Investigational Device Exemption (DE) - ANSWER Allows the investigation
device to be used in a clinical study in order to collect safety and effectiveness
data required to support a PMA or PMN [510(k)] submission.
Labeling - ANSWER All written, printed or graphic matter accompanying an
article at any time while such article is in interstate commerce or held for sale
after shipment in interstate commerce; includes user manuals, brochures,
advertising, etc.
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Humanitarian Use Device (HUD) - ANSWER a device that is intended to
benefit patients in the treatment or diagnosis of a disease or condition
affecting fewer than 8,000 individuals in the US per year
2. Implantable Medical Device (IMD) - ANSWER A medical device intended
to be wholly introduced into the body by surgical intervention and stay in
place; to replace an epithelial surface or the surface of an eye in a human
by surgical intervention and stay in place; or to be partially introduced into
the body by surgical intervention and remain in place for at least 30 days
after the procedure.
3. In Vitro Diagnostic Device (IVDD) - ANSWER Any medical device which is
a reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment, or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for the examination of
specimens. Also IVD and IVMD.
,4. In Vitro Diagnostic Devices Directive (IVDD) - ANSWER Directive
98/79/EC, Covers devices used in vitro to examine specimens derived from
the human body, including reagents, instruments and specimen receptacles.
5. In Vitro Diagnostic Medical Devices Regulation (IVDR) - ANSWER
Regulation (EU) 2017/746 of the European Parliament and of the Council on
in vitro diagnostic medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU. Also known as EU IVDR.
6. In Vitro Diagnostic Medical Device (IVD per EU IVDR) - ANSWER Any
medical device which is a reagent, reagent product, calibrator, control
material, kit, instrument, apparatus, equipment, or system, whether used
alone or in combination, intended by the manufacturer to be used in vitro
for the examination of specimens, including blood and tissue donations,
derived from the human body, solely or principally for the purpose of
providing information on a physiological or pathological process or state; a
congenital physical or mental impairments; the predisposition to a medical
condition or a disease; the safety and compatibility with potential
recipients; predicting treatment response or reactions; or defining or
monitoring therapeutic measures. Specimen receptacles are also in vitro
diagnostic medical devices.
7. In Vitro Diagnostic Medical Device (IVD) - ANSWER Any medical device
which is a reagent, reagent product, calibrator, control material, kit,
instrument, apparatus, equipment, or system, whether used alone or in
combination, intended by the manufacturer to be used in vitro for the
examination of specimens. Also IVDD.
,8. In Vitro Medical Device (IVMD) - ANSWER Any medical device which is a
reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment, or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for the examination of
specimens. Also IVD and IVDD.
9. Installation Qualification (IQ) - ANSWER A series of tests designed to
provide documentary evidence that the system has been built and installed
correctly and that all required supporting services and capacity, water and
compressed air systems of the required quality and capacity are available
and connected correctly.
10.Instructions for Use (IFU) - ANSWER Information provided by a device
manufacturer to inform the device user of the medical device's intended
purpose and proper use and of any precautions to be taken.
11.Intellectual Property (IP) - ANSWER Creations of the mind, including
inventions, literary and artistic works, and symbols, names, images, and
designs used in commerce.
12.Intellectual Property Rights (IPRs) - ANSWER The area of law that
regulates the ownership and use of creative works, including patent,
copyright, and trademark law. Intellectual property rights have been
developed to protect creative people who have disclosed their work for the
benefit of humankind from having it copied or imitated without their
consent.
, 13.International Medical Device Regulators Forum (IMDRF) - ANSWER Body
comprising representatives from the medical device regulatory authorities
of Australia, Brazil, Canada, China, EU, Japan, Russia, and US that provides
guidance on strategies, policies, and directions for international medical
device regulatory harmonization. Replaced GHTF.
14.International Organization for Standardization (ISO) - ANSWER A
network of 161 national standards institutes working in partnership with
international organizations, governments, industry, business and consumer
representatives, ISO develops worldwide industrial and commercial
standards.
15.Interoperability - ANSWER Ability of two or more products,
technologies, or systems, which may include medical devices, to exchange
information and use the information that has been exchanged.
Invasive device - ANSWER A device, which, in whole or in part, penetrates
inside the body, either through a body orifice or through the surface of the body.
Investigational Device Exemption (DE) - ANSWER Allows the investigation
device to be used in a clinical study in order to collect safety and effectiveness
data required to support a PMA or PMN [510(k)] submission.
Labeling - ANSWER All written, printed or graphic matter accompanying an
article at any time while such article is in interstate commerce or held for sale
after shipment in interstate commerce; includes user manuals, brochures,
advertising, etc.
