US Medical Device Regulations Quiz

Under the Quality System Regulation, management is responsible for establishing a quality policy for the company, periodically reviewing quality control procedures, and hiring and training necessary quality assurance staff. However, providing IRB (Institutional Review Board) approval is not a responsibility of management under the Quality System Regulation. IRB approval is typically required for research involving human subjects and is the responsibility of the IRB itself, not management.

The product code is the most helpful descriptor in narrowing a search for a known device using FDA's classification database. This is because the product code is a specific code assigned to each type of medical device, allowing for a more targeted search. The regulation number, classification, and submission type may provide some information, but they are not as specific as the product code in identifying a particular device.

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the predicate device. In the context of medical devices, a predicate device is an existing device that is used as a reference for demonstrating the safety and effectiveness of a new device seeking approval. By comparing the new device to the predicate device, manufacturers can show that their product is substantially equivalent and meets the necessary regulatory requirements for market approval.

If the defective product has caused patient injuries and there is a possibility of further reversible medical consequences, it indicates a moderate level of risk. Class II recall classification is typically assigned when a product may cause temporary or medically reversible health consequences, but the probability of serious adverse effects is low. Therefore, Class II recall classification would most likely be assigned in this scenario.

Obtaining FDA approval before implementing the change may not be required for design changes to an FDA-cleared or approved device. This is because design changes that are considered minor and do not affect the safety or effectiveness of the device may not require FDA approval. However, it is important to document the change in the Device Master Record, verify or validate the change before implementing, and review and approve the change according to an established design change procedure to ensure compliance with regulations and maintain the quality of the device.

The Design History File is a comprehensive record of the design history and development process of a medical device. It is used to provide evidence that the Design Controls procedures were followed, record the results of clinical trials, and document verification of sterilization testing. However, archiving results of customer complaints is not one of the purposes of the Design History File. Customer complaints are typically documented separately in a Complaints File or a similar system to track and address any issues raised by customers.

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Clinical studies are typically conducted during the Product Validation phase of the medical device life cycle. This phase involves testing the device in a real-world setting to gather data on its safety and effectiveness. The purpose of these studies is to generate the necessary evidence to support premarket submissions, such as FDA approval or CE marking. These studies often involve human subjects and aim to demonstrate that the device meets the intended purpose and performs as intended.

Investigational Device Exemption (IDE) approval is not required by the FDA prior to conducting a nonsignificant risk clinical study. FDA regulations state that an IDE is only necessary for significant risk studies involving investigational devices. In a nonsignificant risk study, the device being used is already FDA-approved or is being used in accordance with its approved labeling, and therefore does not require IDE approval. However, other requirements such as a study protocol, informed consent, and Institutional Review Board (IRB) approval are still necessary for conducting the study.

Submitting a 510(k) application to a third-party reviewer can reduce the time required to obtain FDA clearance or approval. Third-party reviewers are authorized by the FDA to review and provide feedback on 510(k) submissions. By using a third-party reviewer, the review process can be expedited as they have expertise in evaluating medical devices and can provide a more efficient and timely assessment compared to the FDA. This can help in accelerating the overall approval process and reduce the time required to obtain FDA clearance or approval.

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Clinical studies involving investigational devices are not intended to manage patient care. The purpose of these studies is to evaluate the safety and effectiveness of the device being investigated. Study results can indeed be used to establish device safety, and institutional review board (IRB) approval is required before starting a study to ensure ethical considerations are met. Additionally, studies can be used to evaluate device concepts and refine study protocols. However, the primary focus of clinical studies involving investigational devices is not to manage patient care but to gather data for regulatory approval and to inform future medical practice.

The de novo pathway is a regulatory pathway established by the FDA that allows for the classification of low to moderate-risk new devices that do not have a predicate device to be cleared through the 510(k) process. This means that these devices can be cleared for marketing without the need for clinical data. This statement is true because it accurately describes the purpose and function of the de novo pathway in FDA premarket submissions.

The Quality System Regulation requires design reviews and/or phase reviews prior to market launch, manufacturers to monitor the performance of their devices after market launch, and clinical studies to be conducted with prototypes manufactured using methods and procedures expected to be used for ongoing production. However, changes to design input after market launch do not require FDA approval.

During the Feasibility Phase, the FDA regulates the collection of human study data. This is because the FDA wants to ensure that any data collected during this phase is done so in a safe and ethical manner. Collecting human study data involves gathering information from human participants, which may include things like medical history, physical examinations, and other relevant data. The FDA wants to ensure that this data collection process is conducted in accordance with their guidelines to protect the rights and safety of the participants.

During studies to demonstrate proof of concept, design controls procedures may not be necessary as the main goal is to determine the feasibility and viability of the concept rather than developing a commercial product. Design controls procedures are typically followed when there is a need to ensure that the product meets the intended requirements and is safe and effective for its intended use. However, in this particular situation, where the focus is on demonstrating proof of concept rather than developing a commercial product, design controls procedures may not be required.

The Medical Device Amendments of 1976 authorized the implementation of various regulations to ensure the safety and effectiveness of medical devices. Good manufacturing practices, substantial equivalence, and clinical study requirements were all regulations that were authorized by these amendments. However, design controls were not specifically mentioned or authorized by the Medical Device Amendments of 1976. Therefore, design controls are the correct answer as they were not included in the list of regulations authorized by the amendments.

Misbranding is included in the "General Controls" provisions by FDA. Misbranding refers to the act of labeling a product in a false or misleading manner, which includes false claims about its effectiveness or safety. The FDA regulates misbranding to protect consumers from deceptive practices and ensure that products are accurately labeled. This control is important for maintaining the integrity of the healthcare industry and safeguarding public health.

A traditional 510(k) submission is required when there is a major change to the fundamental scientific technology of a device, and the FDA has published guidance on this technology with established special controls. This type of submission is used for modifications to existing devices that do not require a premarket approval (PMA) application. It allows the company to demonstrate that the modified device is as safe and effective as the original device, using appropriate testing and data.

Design input is considered to be one of the most important Design Controls related activities by the FDA. Design input refers to the requirements and specifications that are defined for a medical device. It includes the intended use, performance characteristics, and user needs. Design input is crucial in ensuring that the final product meets the necessary safety and effectiveness requirements. It serves as the foundation for the entire design and development process, guiding the creation of the device. By prioritizing design input, the FDA emphasizes the importance of clearly defining and documenting the requirements for a medical device before proceeding with its design and development.