RAC Practice Exam 2 Questions and Answers| Verified Answers

RAC Practice Exam 2 Questions and Answers| Verified Answers

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 [Ans: - 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.

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 [Ans: - 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/ucm136265.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

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 [Ans: - 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.

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 [Ans: - 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.

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 [Ans: - A.