BME 302 FINAL PAPER 2026 QUESTIONS WITH
ANSWERS GRADED A+
◉ 3 FDA classes. Answer: Class 1- little/ no risk: tongue depressors and
bandages. Only few need PMN
Class 2- some risk: Wheelchairs and hearing aids. Almost all need PMN
Class 3- serious risk: pacemakers, breast implants. All require PMA
◉ Medical device definition FDA. Answer: any apparatus, implant, in-
vitro reagent, etc, including any component or accessory used for
migration, treatment, diagnosis or prevention of disease or intended to
affect the structure or function of the body without reaching its primary
purpose through chemical action on or within the body and which is not
dependent on being metabolised is a medical device
◉ substantial equivalence (SE). Answer: A new device which is as safe
and effective as it's predicate device(s)
◉ Predicate device. Answer: A legally marketed device to which
equivalence is drawn is commonly known as the "predicate"
, ◉ GMP. Answer: good manufacturing practice is a quality assurance
system that gives a manufacturer control over any process variables
critical to the performance of the product
◉ Approval Routes. Answer: 1- 510k PMN- Pre market Notification
needed for some Class 1 and all Class 2 products
2- PMA- Premarket Approval, needed for all Class 3 devices
◉ harmonised standard. Answer: A harmonised standard is a European
standard developed by a recognised european standards organisation e.g
CEN which can be used by manufacturers to demonstrate that they
comply with relevant EU legalisation
◉ Medical Ethics. Answer: study of moral values and judgements as
they apply to medicine
◉ Principles of Medical Ethics. Answer: respect for patient autonomy,
beneficence, non-maleficence, justice
◉ respect for patient autonomy. Answer: the physician has a
responsibility to respect patients' decisions and choices about their own
healthcare
◉ Beneficence. Answer: Promotion of what is best for the patient
ANSWERS GRADED A+
◉ 3 FDA classes. Answer: Class 1- little/ no risk: tongue depressors and
bandages. Only few need PMN
Class 2- some risk: Wheelchairs and hearing aids. Almost all need PMN
Class 3- serious risk: pacemakers, breast implants. All require PMA
◉ Medical device definition FDA. Answer: any apparatus, implant, in-
vitro reagent, etc, including any component or accessory used for
migration, treatment, diagnosis or prevention of disease or intended to
affect the structure or function of the body without reaching its primary
purpose through chemical action on or within the body and which is not
dependent on being metabolised is a medical device
◉ substantial equivalence (SE). Answer: A new device which is as safe
and effective as it's predicate device(s)
◉ Predicate device. Answer: A legally marketed device to which
equivalence is drawn is commonly known as the "predicate"
, ◉ GMP. Answer: good manufacturing practice is a quality assurance
system that gives a manufacturer control over any process variables
critical to the performance of the product
◉ Approval Routes. Answer: 1- 510k PMN- Pre market Notification
needed for some Class 1 and all Class 2 products
2- PMA- Premarket Approval, needed for all Class 3 devices
◉ harmonised standard. Answer: A harmonised standard is a European
standard developed by a recognised european standards organisation e.g
CEN which can be used by manufacturers to demonstrate that they
comply with relevant EU legalisation
◉ Medical Ethics. Answer: study of moral values and judgements as
they apply to medicine
◉ Principles of Medical Ethics. Answer: respect for patient autonomy,
beneficence, non-maleficence, justice
◉ respect for patient autonomy. Answer: the physician has a
responsibility to respect patients' decisions and choices about their own
healthcare
◉ Beneficence. Answer: Promotion of what is best for the patient
