DEVICE RAC EXAM QUESTIONS AND VERIFIED

DEVICE RAC EXAM QUESTIONS AND VERIFIED

CORRECT ANSWERS 2024 UPDATE

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510(k) Premarket Notifications for all of the following medical devices would be

reviewed by CDRH's Office of Device Evaluation except:

• High Flux Hemodialyzer
• Blood specimen collection device
• Piston syringe

D) Cardiopulmonary bypass blood tubing - CORRECT ANSWER: B

A 510(k) submission for any Class III device MUST include:

• Clinical results summary
• Hazards analysis evaluation
• Stability evaluation

D. Certification and summary - CORRECT ANSWER: D

A clinical study sponsor's representative conducts periodic monitoring site visits for all

of the following purposes EXCEPT to:

• Review raw data
• Ensure compliance with the protocol
• Review the protocol with the investigator

D. Ensure the adequacy of the IRB and its procedures - CORRECT ANSWER: D

A company has been given a product from its British subsidiary to market for the first time in the US. The product is marketed in the EU. A project team gathered by the regulatory professional to review the information available for regulatory submission to

FDA should:

• Focus on labeling and marketing since mutual recognition does not require complete

technical review

• Include production, marketing, QA and clinical research for a thorough review
• Summarize financial data and distribution data which are normally required to be

submitted to FDA

• Not be necessary if a Common Technical Document has been prepared by the

subsidiary - CORRECT ANSWER: B

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action?

A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0)

B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30)

• Prior approval supplement

D. Annual report - CORRECT ANSWER: C 1 / 3

A company has received a 10-page FDA-483. The regulatory affairs professional's supervisor has prepared a detailed response assuring the FDA district office that corrective action has been taken for each observation. Which of the following should be done?

• Re-audit the company's corrective actions before the letter is sent
• Re-audit the company's corrective actions within three months because FDA usually

conducts

• Re-audit the company's corrective actions during the next scheduled audit
• Re-audit the company's corrective actions immediately after the letter is sent -

CORRECT ANSWER: A

A company is using a clinical research organization (CR0) to develop the protocol and monitor the clinical investigators for the company's clinical trial. The regulatory affairs professional may interact with the CR0 in which of the following situations?

• Making presentations to the reviewing IRBs
• Making presentations to the reviewing division at FDA
• Witnessing the signing of patient consent forms
• Arranging for FDA investigators to observe treatment of subjects at clinical sites -

CORRECT ANSWER: B

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best

filed as a(n):

• Special 510(k)
• Abbreviated 510(k)
• Traditional 510(k)

D. PMA - CORRECT ANSWER: B

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best

filed as a(n):

• Special 510(k)
• Abbreviated 510(k)
• Traditional 510(k)

D. PMA - CORRECT ANSWER: B?

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) 2 / 3

• Traditional 510(k)

D. De novo 510(k) - CORRECT ANSWER: A

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.

• After submission in a periodic report
• After reporting clinical studies in an annual report

D. After submission of labeling change - CORRECT ANSWER: A

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

effect efficacy

• After submission in a periodic report
• After reporting clinical studies in an annual report

D. After submission of labeling change - CORRECT ANSWER: A

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA?

• The change only needs to be reported in an annual report because the company will

qualify the change and the supplier said the process and specification won't change

• The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or

full pre-approval supplement) because it is a change to the drug substance manufacturing location

• The change does not have to be reported because it is an OTC drug

D. Not enough information - CORRECT ANSWER: B?

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most likely be assigned?

• Class I
• Class II
• Class III
• / 3