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RAC Practice exam 2 –HJ with correct answers
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RAC Practice exam 2 –HJ with correct answers
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RAC Practice exam 2 –HJ with correctanswers
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 - Answers -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.
The following biological products are regulated by CBER EXCEPT:
A. Immunizing toxoids
B. Monoclonal antibodies for in vitro use
C. Monoclonal antibodies for in vivo use
D. Infusion of animal sourced cells into a human - Answers -C.
PHS Act Section 351(a)
SOPP 8001.5 Intercenter Consultative/Collaborative Review Process
Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and
Research
http://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm136265.htm
(http://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm136265.htm)
Monoclonal antibodies for in vivo use were transferred to CDER's Office of New Drugs
(OND) effective 30 June 2003
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 - Answers -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.
Your company's commercial product is manufactured by a third-party manufacturer
(TPM). The manufacturing site undercharges one of the excipients. Without contacting
your company, the TPM decides to rework the batch and now would like the product to
be released upon completion of the investigation. Your technical team contacts you for
regulatory advice on whether the lot can be released upon approval of the investigation.
As a regulatory professional, as a first step you:
A. Recommend the lot be released
B. Recommend the lot not be released
C. Assess whether the rework steps are within the regulatory filing and whether there is
a potential regulatory impact
D. If the rework steps are not in the current filing, submit a postapproval change to
include the rework steps in order to release the material - Answers -C
Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls
Information
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0525gdl00001.PDF
(http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0525gdl00001.PDF)
Guidance for Industry: Immediate Release Solid Oral Dosage Forms
http://www.fda.gov/downloads/Drugs/Guidances/UCM070636.pdf
(http://www.fda.gov/downloads/Drugs/Guidances/UCM070636.pdf)
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm1
24826.htm
(http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm1
24826.htm)
Product release and disposition is a quality responsibility, not regulatory. The regulatory
professional is responsible for reviewing the event and assessing whether the additional
steps performed in the manufacturing process are allowed within the regulatory filing.
The team may decide to include the rework procedure; however, additional data may be
needed for the submission. Therefore the recommended first step is response 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 - Answers -A.
A new intended use requires a 510(k).
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 - Answers -A.
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) - Answers -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/ivdregulatoryassistanc
e/ucm123682.htm
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistan
ce/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.
The two mechanisms to amend an OTC Monograph are:
A. Time & Extent Application (TEA) or Annual Report
B. Time & Extent Application (TEA) or Citizen Petition
C. Annual Report or Preapproval Supplement
D. Citizen Petition or Preapproval Supplement - Answers -B.
21 CFR 10.30, 21 CFR 330.14, Regulation of Non-Prescription Drug Products ODE-IV
(Slide 23 to 25) located at
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdf
(http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdf)
Answer 2, TEA or Citizen Petition, is correct.
A company is developing a combination product consisting of a device that injects a
specially formulated small molecule drug for pain into the muscle tissue. Which of the
following describes the best US regulatory path:
A. The product is regulated as a drug
B. The product is regulated under CDRH
C. The company should file a BLA to obtain US marketing approval
D. The company should submit a request for designation to OCP - Answers -A.
21 CFR 3.4 (http://edocket.access.gpo.gov/cfr_2008/aprqtr/21cfr3.4.htm) is the
regulation regarding how FDA designates combination product review. Designation of
the lead FDA review center is based on the product's Primary Mode of Action (PMOA).
FDA issued a final rule on 25 August 2005 for the definition of PMOA.
Statutory provision regarding product classification and the Office of Combination
Products' roles and responsibilities can be found in FD&C Act Section 563
(http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticAc
tFDCAct/FDCActChapterVDrugsandDevices/ucm110768.htm).
Question Feedback
Primary mode of action is the pain drug and the device is a delivery system.
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) - Answers -A.
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