DEVICE RAC EXAM QU ESTIONS WITH CORRECT

DEVICE RAC EXAM QU ESTIONS WITH CORRECT

ANSWERS GRADED A+

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action?

A. CDER

B. CBER

C. CDRH

• OCP - Correct Answer 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):

• Special 510(k)
• Abbreviated 510(k)
• Traditional 510(k)
• De novo 510(k) - Correct Answer 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:

• Adulteration.
• Improper use
• Misbranded
• Fraudulent - Correct Answer 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?

• This requires a new 510(k) since significant change in product instructions might

affect efficacy. 1 / 3

• After submission in a periodic report
• After reporting clinical studies in an annual report
• After submission of labeling change - Correct Answer A

Which of the following is exempt from GMP/QSR regulations?

• Remanufacturers
• Custom device manufacturers
• Repackagers
• Component manufacturers - Correct Answer 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:

• 5 calendar days
• 15 calendar days
• 30 calendar days
• The next quarterly or annual report - Correct Answer 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?

• The labeling is revised.
• The product is recalled.
• The product is redesigned.
• A "Dear Doctor" letter is issued. - Correct Answer A

A handling and storage system for medical devices must always include:

• Procedures for rotation of stock
• Separate rooms or cages for release and quarantine products
• Procedures for receipt and transfer of product
• Environmentally controlled areas for products with shelf life - Correct Answer C 2 / 3

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?

• You have added new sizes and shapes in the product portfolio.
• You have changed the material composition of the device.
• You have changed the package of the device.
• None of the above. - Correct Answer 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:

• The dates and results of the investigation
• The nature and details of the complaint
• Changes in procedures correcting quality problems
• Any reply to the complainant - Correct Answer C

The QSR calls for the manufacturer of finished devices to carry out all of the following EXCEPT:

• Conduct quality audits by individuals who do not have direct responsibility for the operation being

audited

• Audit operations annually
• Document the dates and results of quality audits and re-audits
• Have findings reviewed by management responsible for the matters audited - Correct Answer B

Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System?

• Production and process controls
• Test and control article characterization
• Packaging and labeling controls
• Facility and equipment controls - Correct Answer B
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