RAC Device Practice Question Set 12 | Quizzes International Law

Question

Answer

Explanation

Which of the following changes can be submitted without an

updated batch record (DHR) for a modified release product?

A. Component change: deletion of color/flavor

B. Equipment change: alternate equipment, same design

C. Process change: adjustment of equipment beyond

D. Site change: same contiguous campus

A. Component change: deletion of color/flavor RAC Book page 116.

Which of the following is NOT a component of the Device Master

Record (DMR)?

A) Device design specifications

B) Manufacturing process specifications

C) Risk management file

D) Quality assurance procedures

C) Risk management file

Risk management file belongs to DHF.

The Device Master Record (DMR) focuses on manufacturing the

device and ensures that all required acti vities are included to build,

test, package, and service it.

Your company is planning to submit a BLA to CBER. The BLA

was pulled together quickly and you are concerned it may

not be complete. FDA's initial filing decision could be a

Refuse to File (RTF) for all of the reasons below EXCEPT:

(A) Data tabulations (line listings) or graphic displays cannot

be interpreted

(B) Clear omission of required sections

(D) Technically deficient electronic submission

RTF is issued when the application is not complete with all

the mandatory information. Option A, B and D will make the

application incomplete before FDA can start the review

process. However the Option C i.e. "An analysis was

incorrectly carried out" may not be the reason for RTF. While

an incorrect analysis is a serious issue that could impact

approval, it's something that the FDA would discover during

the review process, not before. The RTF is about whether the

application is complete enough for the review to even begin.

Which of the following is NOT a responsibility of clinical

investigators?

A. Submitting notices to the IRB of deviations from the

investigational plan

B. Maintaining records of receipt, use and disposition of

investigational product

C. Reporting to the sponsor withdrawal of IRB approval

D. Submitting unanticipated adverse event reports to FDA

D. Submitting unanticipated adverse event reports to

FDA It's the responsibility of Sponsor

All of the following are requirements of an IRB EXCEPT that

it:

A. Is composed of at least five members

B. Includes at least one non-scientific member

C. Obtains informed consent from all subjects

D. Represents the cultural mix of the community

C. Obtains informed consent from all subjects It's the job of Investigator.

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Question Answer Explanation Which of the following changes can be submitted without an updated batch record (DHR) for a modified release product? A. Component change: deletion of color/flavor B. Equipment change: alternate equipment, same design C. Process change: adjustment of equipment beyond D. Site change: same contiguous campus A. Component change: deletion of color/flavor RAC Book page 116. Which of the following is NOT a component of the Device Master Record (DMR)? A) Device design specifications B) Manufacturing process specifications C) Risk management file D) Quality assurance procedures C) Risk management file Risk management file belongs to DHF. The Device Master Record (DMR) focuses on manufacturing the device and ensures that all required activities are included to build, test, package, and service it. Your company is planning to submit a BLA to CBER. The BLA was pulled together quickly and you are concerned it may not be complete. FDA's initial filing decision could be a Refuse to File (RTF) for all of the reasons below EXCEPT: (A) Data tabulations (line listings) or graphic displays cannot be interpreted (B) Clear omission of required sections (C) An analysis was incorrectly carried out (D) Technically deficient electronic submission (C) An analysis was incorrectly carried out RTF is issued when the application is not complete with all the mandatory information. Option A, B and D will make the application incomplete before FDA can start the review process. However the Option C i.e. "An analysis was incorrectly carried out" may not be the reason for RTF. While an incorrect analysis is a serious issue that could impact approval, it's something that the FDA would discover during the review process, not before. The RTF is about whether the application is complete enough for the review to even begin. Which of the following is NOT a responsibility of clinical investigators? A. Submitting notices to the IRB of deviations from the investigational plan B. Maintaining records of receipt, use and disposition of investigational product C. Reporting to the sponsor withdrawal of IRB approval D. Submitting unanticipated adverse event reports to FDA D. Submitting unanticipated adverse event reports to FDA It's the responsibility of Sponsor All of the following are requirements of an IRB EXCEPT that it: A. Is composed of at least five members B. Includes at least one non-scientific member C. Obtains informed consent from all subjects D. Represents the cultural mix of the community C. Obtains informed consent from all subjects It's the job of Investigator.

A medical device manufacturer releases a software update for its infusion pump. The update corrects a bug that, under specific and rare circumstances, could lead to the pump delivering significantly more medication than prescribed, potentially causing serious harm. According to 21 CFR Part 806, is this software update likely to require reporting to the FDA? a) No, because it is a software update and not a physical device correction. b) No, because the situation is rare and has not yet caused actual harm. c) Yes, because the software update is a correction to address a potential issue that could cause serious adverse health consequences. d) Only if the FDA specifically requests information about software updates. c) Yes, because the software update is a correction to address a potential issue that could cause serious adverse health consequences. A medical device company discovers a critical cybersecurity vulnerability in the software of its implanted cardiac pacemakers. Exploitation of this vulnerability could allow unauthorized access and potentially lead to life-threatening malfunctions. The company plans to release an immediate software patch to address this. Under 21 CFR Part 806, when must the company report this action to the FDA? a) Within 30 days of releasing the software patch. b) Only if a pacemaker has already been compromised due to this vulnerability. c) Within 10 working days of initiating the distribution of the software patch, as it is a correction to reduce a potential risk to health. d) No reporting is required for cybersecurity updates as long as no patients have been harmed. c) Within 10 working days of initiating the distribution of the software patch, as it is a correction to reduce a potential risk to health. 21 CFR 806.10 (b) The manufacturer or importer shall submit any report required by paragraph (a) of 21 CFR 806.10 (a) section within 10-working days of initiating such correction or removal.

A consumer experiences an unexpected serious side effect after using an over-the-counter (OTC) cough syrup that is marketed under an existing OTC monograph. Historically, how would the FDA have primarily addressed potential safety concerns related to this monograph? a) By immediately issuing a mandatory recall of all affected products. b) By directly contacting the manufacturer to demand a formulation change. c) Through a lengthy and often inefficient rulemaking process to amend the monograph. d) By issuing an Over-the-Counter Monograph Order Request (OMOR) directly to the manufacturer. c) Through a lengthy and often inefficient rulemaking process to amend the monograph. RAC Book page 29. Under 21st Century CURES act, the old inefficient rulemaking process is replaced with administrative order process. Under the CARES Act, the process for updating or amending OTC drug monographs has been reformed. Instead of the traditional rulemaking process, what is the primary mechanism now used for these changes? a) A direct voting system involving pharmaceutical industry representatives. b) An administrative order process initiated by the FDA or through an OTC monograph order request. c) A series of public workshops and non-binding recommendations. d) A mandatory annual review of all existing OTC monographs by a third-party committee. b) An administrative order process initiated by the FDA or through an OTC monograph order request. A small pharmaceutical company wants to introduce a new sunscreen product with active ingredients and labeling that align with an existing OTC sunscreen monograph. Under the reformed system, if the company identifies a minor deviation in their formulation that they believe is still safe and effective, how might they seek FDA acceptance? a) They must wait for the FDA to proactively update the relevant monograph through an administrative order. b) They can directly market the product and address any FDA concerns if they arise. c) They can submit an Over-the-Counter Monograph Order Request (OMOR) to the FDA to address the specific situation. d) They need to petition Congress to amend the CARES Act. c) They can submit an Over-the-Counter Monograph Order Request (OMOR) to the FDA to address the specific situation. RAC Book page 30.

The OTC monograph reform authorized the FDA to collect user fees. What are the two primary types of user fees mentioned in the text? a) Application fees for new OTC drugs and inspection fees for manufacturing facilities. b) Facility fees and Over-the-Counter Monograph Order Request (OMOR) fees. c) Advertising review fees and post-market surveillance fees. d) Export fees and import fees for OTC drug ingredients. b) Facility fees and Over-the-Counter Monograph Order Request (OMOR) fees. RAC Book page 30. What is a key intended benefit of the OTC monograph reform, as highlighted in the summary? a) To decrease the number of available OTC drug products on the market. b) To slow down the process of addressing safety concerns related to OTC drugs. c) To improve efficiency, timeliness, and predictability of the OTC drug review process. d) To eliminate the need for FDA oversight of OTC drug products. c) To improve efficiency, timeliness, and predictability of the OTC drug review process. An IRB is reviewing a clinical trial sponsored by a pharmaceutical company. The research agreement between the company and the institution outlines the payment terms for the institution. Does the IRB typically have the primary responsibility to review the detailed financial arrangements in this agreement? a) Yes, to ensure the institution is adequately compensated for its resources. b) Yes, to prevent any potential conflicts of interest that could affect the study conduct. c) No, the IRB's primary focus is on the ethical treatment of human subjects and the financial aspects related to subject participation. d) No, this is solely the responsibility of the institution's legal and financial departments. c) No, the IRB's primary focus is on the ethical treatment of human subjects and the financial aspects related to subject participation.

RAC Device Practice Question Set 12, Quizzes of International Law

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