DEVICE RAC ALL QUESTIONS AND ANSWERS
SURE A+
✔✔If a company is planning to market a medical device that is substantially equivalent
to a device marketed before 1976, it can use which regulatory paths:
A. IDE
B. PMA
C. 510(k)
D. Special Assessment Protocol - ✔✔C. 510(k)
510(k). Regulatory Reference: 21 CFR 807, Subpart E
✔✔A defective product was released into distribution and has caused patient injuries.
The patients were treated in a local hospital for reversible medical consequences as a
result of the defective product. What type of recall classification would be assigned to
this product.
A. Class I
B. Class II
C. Class III
D. Class IV - ✔✔B. Class II
Exposure to this product may cause temporary or medically reversible adverse health
consequences. Regulatory Reference: 21 CFR 7.3; 21 CFR 7.41
✔✔A US device contract mfger has customers for whom it mfgs device components
(parts) and finished devices. To date, all products have been either parts for Class II
devices or Class II finished devices. The manager of new business contacts the
regulatory manager to assess the impact of a possible new customer involving a Class
III device. What is the first question the regulatory manager should as in order to begin
assessing the impact of Class III on plant operations?
, A. Is it a sterile device?
B. Is it a component or device that would be mfged?
C. Is it an implantable device?
D. Is it a single use device? - ✔✔B. Is it a component or device that would be mfged?
The cited QSR reference states that this regulation is not applicable to component (part)
manufacturing; so knowing that it is a component may eliminate QSR compliance. To
assess the regulatory impact, one must first know what is to be manufactured at the
site, i.e., component or finished device. Many contract device component manufacturers
do comply with the QSR; however, in this case, knowing that the new business for a
Class III device was to manufacture a component only, would help determine the
applicable regulations. For instance, if the job was to manufacture a component only,
the need for sterilization may be eliminated because the manufacturer of the finished
device may sterilize the component once configured in the finished device. If it were
ascertained that the new business was to produce the finished product, the QSR would
apply, and possibly other requirements such as 21CFR Part 821 Medical Device
Tracking as well. Regulatory Reference: 21CFR 820.1 (a) the Quality System
Regulation (QSR).
✔✔An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k) - ✔✔D. BLA or 510(k)
IVDs can be submitted as a 510(k) under the Food, Drug, and Cosmetic Act or a BLA
under the Public Health Service Act. Regulatory Reference: Public Health Service Act,
Food, Drug, and Cosmetic Act.
✔✔Procedures for identifying the control number for each unit, lot or batch of finished
devices is required for which type of medical device?
A. Surgical gloves
B. X-ray machines
C. Pacemakers
D. Syringes - ✔✔C. Pacemakers
According to 21 CFR 820.65, "Each manufacturer of a device that is intended for
surgical implant into the body or to support or sustain life and whose failure to perform
when properly used in accordance with instructions for use provided in the labeling can
be reasonably expected to result in a significant injury to the user shall establish and
maintain procedures for identifying with a control number each unit, lot, or batch of
finished devices and where appropriate components." The Pacemaker is a Class III
implantable device and is subject to 21 CFR 820.65. Regulatory Reference: 21 CFR
820.65 Traceability
SURE A+
✔✔If a company is planning to market a medical device that is substantially equivalent
to a device marketed before 1976, it can use which regulatory paths:
A. IDE
B. PMA
C. 510(k)
D. Special Assessment Protocol - ✔✔C. 510(k)
510(k). Regulatory Reference: 21 CFR 807, Subpart E
✔✔A defective product was released into distribution and has caused patient injuries.
The patients were treated in a local hospital for reversible medical consequences as a
result of the defective product. What type of recall classification would be assigned to
this product.
A. Class I
B. Class II
C. Class III
D. Class IV - ✔✔B. Class II
Exposure to this product may cause temporary or medically reversible adverse health
consequences. Regulatory Reference: 21 CFR 7.3; 21 CFR 7.41
✔✔A US device contract mfger has customers for whom it mfgs device components
(parts) and finished devices. To date, all products have been either parts for Class II
devices or Class II finished devices. The manager of new business contacts the
regulatory manager to assess the impact of a possible new customer involving a Class
III device. What is the first question the regulatory manager should as in order to begin
assessing the impact of Class III on plant operations?
, A. Is it a sterile device?
B. Is it a component or device that would be mfged?
C. Is it an implantable device?
D. Is it a single use device? - ✔✔B. Is it a component or device that would be mfged?
The cited QSR reference states that this regulation is not applicable to component (part)
manufacturing; so knowing that it is a component may eliminate QSR compliance. To
assess the regulatory impact, one must first know what is to be manufactured at the
site, i.e., component or finished device. Many contract device component manufacturers
do comply with the QSR; however, in this case, knowing that the new business for a
Class III device was to manufacture a component only, would help determine the
applicable regulations. For instance, if the job was to manufacture a component only,
the need for sterilization may be eliminated because the manufacturer of the finished
device may sterilize the component once configured in the finished device. If it were
ascertained that the new business was to produce the finished product, the QSR would
apply, and possibly other requirements such as 21CFR Part 821 Medical Device
Tracking as well. Regulatory Reference: 21CFR 820.1 (a) the Quality System
Regulation (QSR).
✔✔An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k) - ✔✔D. BLA or 510(k)
IVDs can be submitted as a 510(k) under the Food, Drug, and Cosmetic Act or a BLA
under the Public Health Service Act. Regulatory Reference: Public Health Service Act,
Food, Drug, and Cosmetic Act.
✔✔Procedures for identifying the control number for each unit, lot or batch of finished
devices is required for which type of medical device?
A. Surgical gloves
B. X-ray machines
C. Pacemakers
D. Syringes - ✔✔C. Pacemakers
According to 21 CFR 820.65, "Each manufacturer of a device that is intended for
surgical implant into the body or to support or sustain life and whose failure to perform
when properly used in accordance with instructions for use provided in the labeling can
be reasonably expected to result in a significant injury to the user shall establish and
maintain procedures for identifying with a control number each unit, lot, or batch of
finished devices and where appropriate components." The Pacemaker is a Class III
implantable device and is subject to 21 CFR 820.65. Regulatory Reference: 21 CFR
820.65 Traceability
