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RAC Practice exam 2 -HJ/100 Questions With Compete Solutions Rated (A+)
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RAC Practice exam 2 -HJ/100 Questions With CompeteSolutions Rated (A+)
Quiz :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.
Quiz :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 -√Answer :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/ucm1362
65.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
,Quiz :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.
Quiz :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 -
√Answer :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/ucm124826.htm
(http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm124826.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.
Quiz :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).
Quiz :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.
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.
Quiz :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/
ivdregulatoryassistance/ucm123682.htm
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulat
oryassistance/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.
Quiz :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 -√Answer :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.
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