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RAC Device Practice Question Set 5, Quizzes of International Law

Indian Institute of ScienceInternational Law

RAC Device Practice Question Set 3- US

Typology: Quizzes

2024/2025

Uploaded on 04/07/2025

sandeep-srivastava-5
sandeep-srivastava-5 🇮🇳

13 documents

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bg1
Company F's PMA-approved device is a life-supporting
device used outside a device user facility. What
postmarket requirement is likely?
a) Annual reports only
b) Postmarket surveillance studies
c) Quarterly sales reports
d) Biannual user surveys
b) Postmarket surveillance studies
Company G makes a significant change to their PMA-
approved device's design. What should they do?
a) Submit a PMA supplement for approval
b) Notify FDA within 30 days
c) Include it in the next annual report
d) Conduct a new clinical trial
a) Submit a PMA supplement for approval
Company H's PMA-approved device is intended for
pediatric use. What additional postmarket requirement
might they face?
a) Mandatory recall after 5 years
b) Quarterly safety reports
c) Postmarket surveillance studies
d) Annual pediatric-specific clinical trials
c) Postmarket surveillance studies
Company J's PMA-approved device is experiencing
unexpected adverse events in a specific patient
subgroup. What might the FDA require?
a) Immediate device recall
b) A new clinical trial focused on the subgroup
c) Changes to the device labeling only
d) A complete redesign of the device
b) A new clinical trial focused on the subgroup
showing signs of premature battery depletion. What
action is the FDA most likely to take?
a) Immediate recall of all devices
b) Require a postmarket surveillance study
c) Fine the company
d) Revoke the PMA approval
b) Require a postmarket surveillance study
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Download RAC Device Practice Question Set 5 and more Quizzes International Law in PDF only on Docsity!

Company F's PMA-approved device is a life-supporting device used outside a device user facility. What postmarket requirement is likely? a) Annual reports only b) Postmarket surveillance studies c) Quarterly sales reports d) Biannual user surveys b) Postmarket surveillance studies Company G makes a significant change to their PMA- approved device's design. What should they do? a) Submit a PMA supplement for approval b) Notify FDA within 30 days c) Include it in the next annual report d) Conduct a new clinical trial a) Submit a PMA supplement for approval Company H's PMA-approved device is intended for pediatric use. What additional postmarket requirement might they face? a) Mandatory recall after 5 years b) Quarterly safety reports c) Postmarket surveillance studies d) Annual pediatric-specific clinical trials c) Postmarket surveillance studies Company J's PMA-approved device is experiencing unexpected adverse events in a specific patient subgroup. What might the FDA require? a) Immediate device recall b) A new clinical trial focused on the subgroup c) Changes to the device labeling only d) A complete redesign of the device b) A new clinical trial focused on the subgroup Company K's PMA-approved implantable device is showing signs of premature battery depletion. What action is the FDA most likely to take? a) Immediate recall of all devices b) Require a postmarket surveillance study c) Fine the company d) Revoke the PMA approval b) Require a postmarket surveillance study

Which type of PMA supplement is appropriate for changes that enhance the safety of the device or its use? a) Panel-track supplement b) 180-day supplement c) Real-time supplement d) Special PMA supplement d) Special PMA supplement RAC Book page 159. Explanation: The correct answer is d) Special PMA supplement. This type is specifically meant for changes that enhance the safety of the device or the safety in using the device Company M wants to make minor changes to their device's packaging method. Which PMA supplement might be most appropriate? a) Real-time supplement b) 180-day supplement c) Panel-track supplement d) Special PMA supplement a) Real-time supplement “a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant [PMA holder] has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.” In general, we believe a Real-Time PMA Supplement is appropriate for a minor change that can be expected within a product line, which includes changes to:

  • device design
  • software
  • instructions for use, warnings, or precautions or other labeling that does not affect the indications or contraindications
  • sterilization and packaging methods. A manufacturer of a Class III implantable device is preparing a PMA supplement for a minor design change. Which type of PMA supplement is most appropriate? a) Real-Time PMA Supplement b) Special PMA Supplement - Changes Being Effected c) Panel-Track PMA Supplement d) 180-Day PMA Supplement a) Real-Time PMA Supplement Company N wants to add a new indication for use to their PMA-approved device. Which type of PMA supplement should they submit? a) Panel-track supplement b) 180-day supplement c) Real-time supplement d) Special PMA supplement a) Panel-track supplement Explanation: The correct answer is a) Panel-track supplement. This type is meant for changes that require a significant change in the design or performance of the device, or a new indication for use.

Company V has developed a novel artificial intelligence (AI) algorithm for their PMA-approved diagnostic imaging device. The AI is designed to continuously learn and improve its performance based on real-world data. Which of the following represents the most appropriate regulatory approach for implementing this AI update? a) Submit a new PMA application for the AI-enhanced device b) Implement the AI update without FDA notification, as it's a performance improvement c) Obtain a separate 510(k) clearance for the AI componen d) Submit a PMA supplement with a detailed plan for ongoing performance monitoring and update protocols d) Submit a PMA supplement with a detailed plan for ongoing performance monitoring and update protocols The correct answer is d) Submit a PMA supplement with a detailed plan for ongoing performance monitoring and update protocols. For AI/ML-based software as a medical device (SaMD), the FDA has proposed a framework that includes a "predetermined change control plan" in the original submission or supplement. This plan should outline the types of anticipated modifications based on retraining and the associated methodology. Company X submits a PMA application for their Class III device. The FDA determines that the application is not sufficiently complete for substantive review. What is the likely next step? a) The FDA will automatically approve the device b) The FDA will issue a "refuse to file" letter c) The company can immediately market the device d) The FDA will conduct an expedited review b) The FDA will issue a "refuse to file" letter A manufacturer submits a Traditional 510(k) for a new wound dressing product. During the FDA review, the agency requests additional performance testing data beyond what was included in the initial submission. The company realizes that gathering this data will take several months, and the 90-day review clock is running. What is the best course of action for the manufacturer? A) Wait for the FDA to issue a formal decision and then appeal B) Withdraw the current submission and resubmit once the data is ready C) Request an extension of the 90-day review period D) Submit a new 510(k) with only the missing data B) Withdraw the current submission and resubmit once the data is ready Explanation: The correct answer is B. Withdrawing the 510(k) and resubmitting once the missing data is available is the best course of action. The FDA’s 90-day review clock does not pause for additional data requests, and failing to respond adequately may result in a Not Substantially Equivalent (NSE) determination. By withdrawing and resubmitting, the manufacturer avoids an NSE decision and ensures a complete submission.

A company is developing a software-only mobile application intended to analyze ECG waveforms and detect potential arrhythmias. The company believes that their app is similar to a previously cleared ECG analysis software that was marketed as a Class II device through a 510(k). Which of the following factors would most likely require the company to submit a De Novo request instead of a 510(k)? A) The company has improved the app’s user interface for better usability B) The app introduces a new AI-based algorithm that provides automated clinical decision support C) The previous predicate device is still legally marketed D) The app is intended for use only by healthcare professionals B) The app introduces a new AI-based algorithm that provides automated clinical decision support Explanation: The correct answer is B. A De Novo submission is required when there is no valid predicate device or when the new device presents different technological characteristics that raise new questions of safety and effectiveness. In this case, the AI-based automated clinical decision support introduces a new mechanism of action, which may require a different risk classification and additional validation beyond a traditional 510(k). If no substantially equivalent device exists, the manufacturer would need to submit a De Novo request to establish a new classification regulation. A manufacturer is submitting a 510(k) for a new blood pressure monitor. The predicate device they are referencing used oscillometric technology, but their new device includes both oscillometric and auscultatory methods for measurement. What is the most important step the manufacturer should take before submitting the 510(k)? A) Demonstrate that the added auscultatory method does not raise new safety or effectiveness concerns B) Submit without additional testing since the device includes a well-established method C) Submit a De Novo request instead, as it involves new technology D) Select a predicate device that only includes auscultatory measurements A) Demonstrate that the added auscultatory method does not raise new safety or effectiveness concerns In this case, adding an auscultatory method alongside the oscillometric technology changes how the device operates. The manufacturer must provide performance testing (e.g., accuracy, reliability, and clinical validation) to show that the modification does not negatively impact patient safety or device effectiveness.