RAC Device Exam 2026 Expert
Verifed Ace the Test
Form FDA 1572 - ANSWER ✔✔Statement of Investigator- required to
be completed by investigators prior to participating in the conduct of a
clinical trial
Form FDA 482 - ANSWER ✔✔Notice of Inspection- issued by FDA to
an entity prior to the conduct of an inspection to inform the entity that the
agency will conduct an inspection
EIR - ANSWER ✔✔Establishment Inspection Report - FDA
summarizes the inspection and classifies it as No Action Indicated,
Voluntary Action Indicated, or Official Action Indicated.
,Form FDA 483 - ANSWER ✔✔Issued to firm management at the
conclusion of an inspection to review observations.
510(k) - ANSWER ✔✔premarket notification submission based on
medical device being substantially equivalent to a product already on the
market
Active Implantable Medical Device (AIMD) - ANSWER ✔✔An active
device that is intended to be introduced wholly or partially, by surgical or
medical intervention, into the body or introduced into a natural orifice of
the body by medical intervention and to remain in place after the
procedure
Active Implantable Medical Devices Directive (AIMDD) - ANSWER
✔✔Council Directive 90/385/EEC of 20 June 1990 on the approximation
of the laws of the Member States relating to active implantable medical
devices. First EU medical device legislation, implemented in 1995,
applies to active implantable medical devices. This directive, along with
MDD and IVDD, provides the legislative framework within which Member
State Competent Authorities and Notified Bodies regulate the CE-
marking process for placing and maintaining devices on the market
within the EC.
,Active Medical Device (AMD) - ANSWER ✔✔Any medical device, the
operation of which depends on an electrical or other energy source and
acts by converting this energy.
Active Therapeutic Device (ATD) - ANSWER ✔✔Any active medical
device, whether used alone or in combination with other medical
devices, to support, modify, replace, or restore biological functions or
structures with a view to treatment or alleviation of an illness, injury or
handicap.
Advisory Committee on the Safety of Medical Devices (ACSMD) -
ANSWER ✔✔Advises and makes recommendations to the Minister
for Health and TGA on the safety, risk assessment, risk management,
and performance of medical devices supplied in Australia.
Australian Regulatory Guidelines for Medical Devices (ARGMD) -
ANSWER ✔✔Consolidated reference document detailing the
regulatory requirements for medical devices in Australia
Authorized Representative (AR) - ANSWER ✔✔A natural or legal
person established in the EU, explicitly designated by a non-European
manufacturer, who acts on the manufacturer's behalf to carry out certain
tasks required in applicable directives.
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
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, Banned Device - ANSWER ✔✔A device that presents a substantial
deception, unreasonable risk of injury or illness, or unreasonable direct
and substantial danger to the public health
Blue Book - ANSWER ✔✔FDA;s Office of Device Evaluation
guidance memoranda regarding PMN [510(k)] submissions, PMPs,
PDPs, device classifications, and IDEs.
CE Mark - ANSWER ✔✔European Conformity, Conformite
Europeene mark. Mandatory European mark for products falling under
one of the new approach directives (including medical devices) to
indicate conformity with essential health and safety requirements
Center for Devices and Radiological Health (CDRH) - ANSWER
✔✔US FDA center responsible for regulating firms that manufacture,
repackage, re-label and/or import medical devices sold in the US, and
radiation-emitting electronic products (medical and non-medical) such as
lasers, x-ray systems, microwave ovens and color televisions.
Changes Being Effected (CBE) - ANSWER ✔✔A supplement
submission to FDA for a change in a drug, device, production process,
quality controls, equipment, or facilities with a moderate potential to
adversely affect the product's identity, strength, quality, purity, or potency.
Change can be made immediately.
Verifed Ace the Test
Form FDA 1572 - ANSWER ✔✔Statement of Investigator- required to
be completed by investigators prior to participating in the conduct of a
clinical trial
Form FDA 482 - ANSWER ✔✔Notice of Inspection- issued by FDA to
an entity prior to the conduct of an inspection to inform the entity that the
agency will conduct an inspection
EIR - ANSWER ✔✔Establishment Inspection Report - FDA
summarizes the inspection and classifies it as No Action Indicated,
Voluntary Action Indicated, or Official Action Indicated.
,Form FDA 483 - ANSWER ✔✔Issued to firm management at the
conclusion of an inspection to review observations.
510(k) - ANSWER ✔✔premarket notification submission based on
medical device being substantially equivalent to a product already on the
market
Active Implantable Medical Device (AIMD) - ANSWER ✔✔An active
device that is intended to be introduced wholly or partially, by surgical or
medical intervention, into the body or introduced into a natural orifice of
the body by medical intervention and to remain in place after the
procedure
Active Implantable Medical Devices Directive (AIMDD) - ANSWER
✔✔Council Directive 90/385/EEC of 20 June 1990 on the approximation
of the laws of the Member States relating to active implantable medical
devices. First EU medical device legislation, implemented in 1995,
applies to active implantable medical devices. This directive, along with
MDD and IVDD, provides the legislative framework within which Member
State Competent Authorities and Notified Bodies regulate the CE-
marking process for placing and maintaining devices on the market
within the EC.
,Active Medical Device (AMD) - ANSWER ✔✔Any medical device, the
operation of which depends on an electrical or other energy source and
acts by converting this energy.
Active Therapeutic Device (ATD) - ANSWER ✔✔Any active medical
device, whether used alone or in combination with other medical
devices, to support, modify, replace, or restore biological functions or
structures with a view to treatment or alleviation of an illness, injury or
handicap.
Advisory Committee on the Safety of Medical Devices (ACSMD) -
ANSWER ✔✔Advises and makes recommendations to the Minister
for Health and TGA on the safety, risk assessment, risk management,
and performance of medical devices supplied in Australia.
Australian Regulatory Guidelines for Medical Devices (ARGMD) -
ANSWER ✔✔Consolidated reference document detailing the
regulatory requirements for medical devices in Australia
Authorized Representative (AR) - ANSWER ✔✔A natural or legal
person established in the EU, explicitly designated by a non-European
manufacturer, who acts on the manufacturer's behalf to carry out certain
tasks required in applicable directives.
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
3
, Banned Device - ANSWER ✔✔A device that presents a substantial
deception, unreasonable risk of injury or illness, or unreasonable direct
and substantial danger to the public health
Blue Book - ANSWER ✔✔FDA;s Office of Device Evaluation
guidance memoranda regarding PMN [510(k)] submissions, PMPs,
PDPs, device classifications, and IDEs.
CE Mark - ANSWER ✔✔European Conformity, Conformite
Europeene mark. Mandatory European mark for products falling under
one of the new approach directives (including medical devices) to
indicate conformity with essential health and safety requirements
Center for Devices and Radiological Health (CDRH) - ANSWER
✔✔US FDA center responsible for regulating firms that manufacture,
repackage, re-label and/or import medical devices sold in the US, and
radiation-emitting electronic products (medical and non-medical) such as
lasers, x-ray systems, microwave ovens and color televisions.
Changes Being Effected (CBE) - ANSWER ✔✔A supplement
submission to FDA for a change in a drug, device, production process,
quality controls, equipment, or facilities with a moderate potential to
adversely affect the product's identity, strength, quality, purity, or potency.
Change can be made immediately.
