federal regulations exam 1

Question 1

what is class I of medical devices

Answer 1

present minimal potential for harm to the user; general regulatory control

exempt or premarket notification 510K

Question 2

what are examples of class I medical devices

Answer 2

bandages, gloves, dental floss

Question 3

what is class II of medical devices

Answer 3

general and special control to assure safety and effectiveness (special labeling, performance standards, premarket surveillance)

510K or exempt (few)

Question 4

what are examples of class II medical devices

Answer 4

powered wheelchairs, infusion pumps, surgical drapes

Question 5

what is class III of medical devices

Answer 5

used to support/sustain human life/prevent impairment of human health

premarket approval or 510K for those introduced before 5/28/1976

Question 6

what are examples of class III medical devices

Answer 6

heart valve, silicone gel-filled breast implants, engineered tissue constructs, nanoparticle-drug formulations

Question 7

what devices are exempt from 510K

Answer 7

preamendment devices not significantly changed or modified since 5/28/1976 or class I/II devices specifically exempted by the FDA

Question 8

what is a 510K

Answer 8

a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective to a legally marketed device that is not subject to PMA

Question 9

what are the 510K requirements

Answer 9

laboratory testing and submission of 510K at least 90 days before marketing, must compare the device to one or more similar legally marketed devices that is not subject to PMA

Question 10

what is premarket approval (PMA)

Answer 10

FDA process of scientific and regulatory review to evaluate the safety and efficacy of clas III medical devices

Question 11

what are the data requirements of PMA

Answer 11

good science and scientific writing, technical sections include non-clinical laboratory studies and clinical investigations

Question 12

how long does FDA take to review PMA and make decision

Answer 12

180 days

Question 13

what is phase I of PMA

Answer 13

Small # of patients to determine a safe dosage range for safety

Question 14

what is phase II of PMA

Answer 14

Large # of patients to determine efficacy and further evaluate safety

Question 15

what is phase III of PMA

Answer 15

Large # of patients to confirm efficacy and safety and compare to
commonly used treatments

Question 16

what is phase IV of PMA

Answer 16

Post FDA approval to further collect data on safety and efficacy

Question 17

what are investigational new drug (IND) or investigational device exemption (IDE)

Answer 17

allows the investigational new drug or device to be used in a clinical study to collect safety and efficacy data required to support a PMA application or 510K submission

Question 18

what do clinical evaluation of new drugs or devices that have not been cleared for marketing require

Answer 18

• An IND or IDE approved by an institutional review board (IRB)
  or FDA if involving significant risk
• Informed consent from all patients
• Labeling for investigational use only
• Monitoring of the study and
• Requiring records and reports

Question 19

what marketing classes require 510K if not exempt

Answer 19

I and II

Question 20

what marketing classes require PMA

Answer 20

III and new drugs