RAC Sample Exam Questions and Revised Answers (All are Correct) Update
3 views 0 purchase
Course
RAC
Institution
RAC
RAC Sample Exam Questions and Revised Answers (All are Correct) Update
When would you report a malfunction of a device that injured a patient to FDA?
a) Withing 24 hours
b) Within 14 days
c) Within 30 days
d) When you have found a fix for the malfunction and are ready to implement it in ...
RAC Sample Exam Questions and
Revised Answers (All are Correct)
2024-2025 Update
When would you report a malfunction of a device that injured a patient to FDA?
a) Withing 24 hours
b) Within 14 days
c) Within 30 days
d) When you have found a fix for the malfunction and are ready to implement it in the
field. - Answer ✔ c) Within 30 days
FDA and FTC share responsibilities in regulating healthcare products. FDA has
authority over labeling plus:
a) the advertising of OTC drugs
b) the advertising or prescription drugs
c) the advertising of restricted devices
d) a and b
e) b and c(20:1) - Answer ✔ e) b(the advertising or prescription drugs) and c(the
advertising of restricted devices)
The Supreme Court in Kordel v United States provided a new interpretation on:
a) the definition of label
b) the definition of labeling
c) the physical grouping of labeling and the device was not necessary
d) a and c(20:2) - Answer ✔ c) the physical grouping of labeling and the device was not
necessary
a) not providing adequate directions for use
b) not stating performance claims for the device
c) not providing enough information on the risks
d) a and c
,e) a,b and c(20:4) - Answer ✔ e) a(not providing adequate directions for use), b(not
stating performance claims for the device) and c(not providing enough information on
the risks)
FDA approved labeling is part of the submission process with:a) PMA, 510(k)b) PMA,
BLA, and NDAc) PMA and IDEd) ASR, 510(k), and PMA(20:5) - Answer ✔ b) PMA,
BLA, and NDA
True or False: An IVD can be either a device or a biologic.(21:1) - Answer ✔ True
True or False: "IVDMIA" stands for In Vitro Diagnostic Multivariate Index Analyte.(21:2) -
Answer ✔ False. "IVDMIA" stands for In Vitro Diagnostic Multivariate Index Assay.
True or False: A Class III novel analyte will be referred by FDA to an advisory panel
before approval and will require prospective clinical data.(21:3) - Answer ✔ False. A
novel analyte is likely to be referred to an advisory panel, but panel review is not
mandatory. While some PMAs require prospective clinical data, FDA accepts the use of
remnant or banked specimens under certain conditions and for certain types or
products.
For a device to be cleared under a traditional 510(k), a product sponsor must prove to
FDA that:
a) the new device has the same intended use as a previously cleared device
b) the new device is substantially equivalent to a previously cleared device
c) the new device improves on the technology of a previously cleared device.(21:4) -
Answer ✔ b) the new device is substantially equivalent to a previously cleared device
RUO and IUO products
a) cannot be marketed with diagnostic claims
b) are subject to QSR requirements
c) are considered safe and effective for IVD use(21:5) - Answer ✔ a) cannot be
marketed with diagnostic claims
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to
multiple sites. Which of the following statements are true?
a) Each contract facility must be listed in its own establishment license application
(ELA).
b) Each contract facility must be listed in the BLA.
c) Each contract facility must appear in the product labeling.
d) Each contract facility must take responsibility for compliance with applicable
establishment and product requirements for biologics.
e) b and d
, f) All of the above(22:1) - Answer ✔ e) b:Each contract facility must be listed in the BLA
and d: Each contract facility must take responsibility for compliance with applicable
establishment and product requirements for biologics.
When FDA receives a biologics license application and determines it to be incomplete,
the agency may:
a) Issue a "Not Approvable " letter
b) Issue a "Refusal to File" letter
c) Place a clinical hold on the IND
d) Issue a "Complete Response" lettere) b and d(22:2) - Answer ✔ e) b: Issue a
"Refusal to File" letter and d: Issue a "Complete Response" letter
Biological products are approved for marketing under provisions of:
a) Food, Drug, and Cosmetic Act
b) Acceptable GMP inspection
c) Public Heath Service Act
d) a and b
e) All of the above(22:3) - Answer ✔ e) all of the above
If two or more biotech manufacturers are each registered with FDA and licensed to
manufacture a product in its entirety, they are what type of manufacturing arrangement?
a) Sole
b) Short supply
c) Divided
d) Shared
e) Contract(22:4) - Answer ✔ c) Divided
The Biologics Control Act passed in 1902 authorized or provided for the following:
a) Regulation of the sales of viruses, serums, toxins and analogous products
b) Required licensing of manufacturing establishments
c) Provided inspection authority to the federal government
d) All of the above(22:5) - Answer ✔ d) All of the above
Which of the following statements is true for drugs, but not for biologics?
a) Adverse events are reported on Form 3500A
b) Requires Annual Reports to update the IND
c) Approval of labeling and advertising is required
d) Must be manufactured according to GMPs
e) All of the above statements are true for both.(22:6) - Answer ✔ e) All of the above
statements are true for both.
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Scholarsstudyguide. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.99. You're not tied to anything after your purchase.
