RAC (Device) -HJ Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. You work for a German-based device manufacturer (Company A) that produces
a power supply based on a US-based medical device company's (Company B)
design. The power supply is imported into your company's US-based
manufacturing site (Company C) for further processing and then sent to the US-
based medical device company (Company B) for final assembly. Which company
needs to register with FDA:
A. Company A
B. Company B
C. Company A &B
D. Company A, B &C - ANSWER B.
Company A qualifies as a foreign component manufacturer and as such, does not
require establishment registration under 21 CFR 807.65(a).
Company C is the initial imported of a component and does not need register
under 21 CFR 807.20.
,2. A company is developing a new device and the classification under which it
would fall is unclear. As the regulatory professional, you would submit the
following:
A. 510(k) Premarket Notification
B. Request for Designation
C. 513(g) Request for Information
D. Type A Meeting Request - ANSWER C.
A 513(g) Request for Information is submitted to ask FDA to determine a device's
classification and applicable requirements under the FD&C Act.
- A 510(k) submission is filed when a device's classification is known and the
device is compared to a predicate device to obtain FDA clearance.
- A Request for Designation asks FDA to determine whether a product is a drug,
device, biological product or combination product.
- A Type A Meeting is needed to help an otherwise stalled product development
program proceed.
3. A company's competitor is marketing a Class II suture that dissolves during the
third week of use. The company's current product has to be removed by a
physician. However, a change in weaving configuration gives this product the same
dissolving time as the competitor's. What needs to be done for the company to
market this new dissolving suture?
A. Filing a new 510(k) documenting changes in product instructions for use
B. Submission of changes in a periodic report
C. After-reporting clinical studies in an Annual Report
,D. After-submission of labeling change - ANSWER A.
A new intended use requires a 510(k).
4. While reviewing product complaint files for MDR reportability, you notice a
complaint regarding a common failure mode of an implantable screw. No patient
involvement or adverse consequences were reported in the complaint. Your firm
has initiated a Class I recall for this implantable screw due to safety issues
associated with this failure mode. As a regulatory professional your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode
likely will cause or contribute to death or serious injury
C. No MDR is needed as there is no patient involvement and no adverse
consequences were reported
D. No MDR is needed but you will file this complaint in the recall file - ANSWER
A.
5. When a recall is initiated for a particular product failure mode, such failure
mode automatically is MDR-reportable to FDA. Additionally, while the complaint
did not report an adverse event, the manufacturer should evaluate the potential
to cause an adverse event if the failure mode was to re-occur.
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
, D. BLA or 510(k) - ANSWER D.
IVDs could be submitted as a 510(k) under the FD&C Act or a BLA under the PHS
Act.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatorya
ssistance/ucm123682.htm
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatory
assistance/ucm123682.htm)
Regulatory Authority: IVDs are "medical devices" as defined in Federal Food, Drug,
and Cosmetic Act Section 210(h) or biological products subject to Public Health
Service Act Section 351.
6. Which federal law made it illegal for physicians reimbursed by federally funded
programs to prescribe or recommend a patient use a particular manufacturer's
medical products when the doctor receives payment from that manufacturer?
A. Medicare and Medicaid Patient Protection Act of 1987
B. Food, Drug, and Cosmetic Act of 1938 (FD&C Act)
C. Food and Drug Administration Modernization Act of 1997 (FDAMA)
D. Food and Drug Administration Amendments Act of 2007 (FDAAA) - ANSWER
A.
The Medicare and Medicaid Patient Protection Act of 1987 is also known as the
Federal Anti-Kickback Statute and makes it illegal for any person—e.g., healthcare
provider, office manager or sales agent—to knowingly and willingly solicit, offer,
pay or receive "remuneration" (including kickbacks, bribes, rebates or anything of
value) directly or indirectly in cash or in kind to any person to induce or cause that
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. You work for a German-based device manufacturer (Company A) that produces
a power supply based on a US-based medical device company's (Company B)
design. The power supply is imported into your company's US-based
manufacturing site (Company C) for further processing and then sent to the US-
based medical device company (Company B) for final assembly. Which company
needs to register with FDA:
A. Company A
B. Company B
C. Company A &B
D. Company A, B &C - ANSWER B.
Company A qualifies as a foreign component manufacturer and as such, does not
require establishment registration under 21 CFR 807.65(a).
Company C is the initial imported of a component and does not need register
under 21 CFR 807.20.
,2. A company is developing a new device and the classification under which it
would fall is unclear. As the regulatory professional, you would submit the
following:
A. 510(k) Premarket Notification
B. Request for Designation
C. 513(g) Request for Information
D. Type A Meeting Request - ANSWER C.
A 513(g) Request for Information is submitted to ask FDA to determine a device's
classification and applicable requirements under the FD&C Act.
- A 510(k) submission is filed when a device's classification is known and the
device is compared to a predicate device to obtain FDA clearance.
- A Request for Designation asks FDA to determine whether a product is a drug,
device, biological product or combination product.
- A Type A Meeting is needed to help an otherwise stalled product development
program proceed.
3. A company's competitor is marketing a Class II suture that dissolves during the
third week of use. The company's current product has to be removed by a
physician. However, a change in weaving configuration gives this product the same
dissolving time as the competitor's. What needs to be done for the company to
market this new dissolving suture?
A. Filing a new 510(k) documenting changes in product instructions for use
B. Submission of changes in a periodic report
C. After-reporting clinical studies in an Annual Report
,D. After-submission of labeling change - ANSWER A.
A new intended use requires a 510(k).
4. While reviewing product complaint files for MDR reportability, you notice a
complaint regarding a common failure mode of an implantable screw. No patient
involvement or adverse consequences were reported in the complaint. Your firm
has initiated a Class I recall for this implantable screw due to safety issues
associated with this failure mode. As a regulatory professional your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode
likely will cause or contribute to death or serious injury
C. No MDR is needed as there is no patient involvement and no adverse
consequences were reported
D. No MDR is needed but you will file this complaint in the recall file - ANSWER
A.
5. When a recall is initiated for a particular product failure mode, such failure
mode automatically is MDR-reportable to FDA. Additionally, while the complaint
did not report an adverse event, the manufacturer should evaluate the potential
to cause an adverse event if the failure mode was to re-occur.
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
, D. BLA or 510(k) - ANSWER D.
IVDs could be submitted as a 510(k) under the FD&C Act or a BLA under the PHS
Act.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatorya
ssistance/ucm123682.htm
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatory
assistance/ucm123682.htm)
Regulatory Authority: IVDs are "medical devices" as defined in Federal Food, Drug,
and Cosmetic Act Section 210(h) or biological products subject to Public Health
Service Act Section 351.
6. Which federal law made it illegal for physicians reimbursed by federally funded
programs to prescribe or recommend a patient use a particular manufacturer's
medical products when the doctor receives payment from that manufacturer?
A. Medicare and Medicaid Patient Protection Act of 1987
B. Food, Drug, and Cosmetic Act of 1938 (FD&C Act)
C. Food and Drug Administration Modernization Act of 1997 (FDAMA)
D. Food and Drug Administration Amendments Act of 2007 (FDAAA) - ANSWER
A.
The Medicare and Medicaid Patient Protection Act of 1987 is also known as the
Federal Anti-Kickback Statute and makes it illegal for any person—e.g., healthcare
provider, office manager or sales agent—to knowingly and willingly solicit, offer,
pay or receive "remuneration" (including kickbacks, bribes, rebates or anything of
value) directly or indirectly in cash or in kind to any person to induce or cause that
