Exam (elaborations)
DEVICE RAC EXAM QUESTIONS & ANSWERS
- Course
- Institution
DEVICE RAC EXAM QUESTIONS & ANSWERS
[Show more]
Seller
Follow
Victorious23
Reviews received
Content preview
DEVICE RAC EXAM QUESTIONS & ANSWERSWhich division would have primary jurisdiction over a vascular graft with an
antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - -C
-A company wants to modify its legally marketed device such that the
modification does not affect the intended use or alter the fundamental
scientific technology of the device. If the design outputs of the modified
device meet the design input requirements, this change would be best filed
as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - -A
-Under the statutory violations, failure to meet 510(k) requirements for a
device that is required to have a 510(k) and is in commercial distribution is
considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - -C
-A company's competitor is marketing a Class II suture which 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. When can the
company's new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions
might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change - -A
-Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - -D
, -A physician reports to a manufacturer that a patient was hospitalized with
acute sepsis after treatment with an approved device. This side effect is not
listed in the package insert. This event must be reported by the
manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - -C
-If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper use by the end user, which
of the following typically occurs?
A. The labeling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued. - -A
-A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - -C
-You have modified your 510(k) cleared device with a special 510(k). In
which of the following cases would you need to create a new listing for the
device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - -D
-According to the QSR, when an investigation of a complaint is conducted all
of the following are requirements for inclusion in the record of the
investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - -C
-The QSR calls for the manufacturer of finished devices to carry out all of the
following EXCEPT:
A. Conduct quality audits by individuals who do not have direct responsibility
for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
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 Victorious23. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75632 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now