RAPs questions with verified answers
510(k) Ans✔✔✔-Premarket notification submission based on medical device
being substantially equivalent to a product already on the market
Active Implantable Medical Device (AIMD) Ans✔✔✔-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) Ans✔✔✔-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 directed, along with MDD and IVDD, provides the legislative
framework within with 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) Ans✔✔✔-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) Ans✔✔✔-Any medical device, whether used
along 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) Ans✔✔✔-Advices
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) Ans✔✔✔-
Consolidated reference document detailing the regulatory requirements for
medical devices in Australia
Authorized Representative (AR) Ans✔✔✔-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.
Banned Device Ans✔✔✔-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 Ans✔✔✔-FDA's Office of Device Evaluation guidance memoranda
regarding PMN [510(k)] submissions, PMPs, PDPs, device classifications, and IDEs
CE Mark Ans✔✔✔-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) Ans✔✔✔-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) Ans✔✔✔-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
Class I Device Ans✔✔✔-Requires general controls to ensure safety and
effectiveness
Class II Device Ans✔✔✔-Requires general and special controls to ensure safety
and effectiveness. Special controls may include mandatory performance
standards, patient registries for implantable devices and postmarket surveillance.
Requires 510(k) unless exempted; may require clinical trials. Class II devices are
divided into IIa and IIb
Class IIa Devices Ans✔✔✔-Class IIa are devices installed in the body in the short
term (usually 60 minutes to 30 days). These devices tend to exchange energy with
a patient in a therapeutic manner or are used to diagnose or monitor medical
conditions. They are generally invasive but only limited to natural orifices. If this
kind of device is in some way potentially hazardous to the patient, it automatically
becomes Class IIb.
Class IIb Devices Ans✔✔✔-Class IIb are slightly more complex devices than IIa
devices and are often installed within the body for more than 30 days. Class IIb
refers to most surgically invasive or active devices which are partially or entirely
implanted into the body. This class may also modify the composition of bodily
fluids.
Class III Device Ans✔✔✔-Requires general controls, special controls and PMA.
Includes devices that are life-sustaining, life-supporting, or pose potential risk to
patients. PMA may require clinical trials.
510(k) Ans✔✔✔-Premarket notification submission based on medical device
being substantially equivalent to a product already on the market
Active Implantable Medical Device (AIMD) Ans✔✔✔-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) Ans✔✔✔-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 directed, along with MDD and IVDD, provides the legislative
framework within with 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) Ans✔✔✔-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) Ans✔✔✔-Any medical device, whether used
along 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) Ans✔✔✔-Advices
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) Ans✔✔✔-
Consolidated reference document detailing the regulatory requirements for
medical devices in Australia
Authorized Representative (AR) Ans✔✔✔-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.
Banned Device Ans✔✔✔-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 Ans✔✔✔-FDA's Office of Device Evaluation guidance memoranda
regarding PMN [510(k)] submissions, PMPs, PDPs, device classifications, and IDEs
CE Mark Ans✔✔✔-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) Ans✔✔✔-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) Ans✔✔✔-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
Class I Device Ans✔✔✔-Requires general controls to ensure safety and
effectiveness
Class II Device Ans✔✔✔-Requires general and special controls to ensure safety
and effectiveness. Special controls may include mandatory performance
standards, patient registries for implantable devices and postmarket surveillance.
Requires 510(k) unless exempted; may require clinical trials. Class II devices are
divided into IIa and IIb
Class IIa Devices Ans✔✔✔-Class IIa are devices installed in the body in the short
term (usually 60 minutes to 30 days). These devices tend to exchange energy with
a patient in a therapeutic manner or are used to diagnose or monitor medical
conditions. They are generally invasive but only limited to natural orifices. If this
kind of device is in some way potentially hazardous to the patient, it automatically
becomes Class IIb.
Class IIb Devices Ans✔✔✔-Class IIb are slightly more complex devices than IIa
devices and are often installed within the body for more than 30 days. Class IIb
refers to most surgically invasive or active devices which are partially or entirely
implanted into the body. This class may also modify the composition of bodily
fluids.
Class III Device Ans✔✔✔-Requires general controls, special controls and PMA.
Includes devices that are life-sustaining, life-supporting, or pose potential risk to
patients. PMA may require clinical trials.
