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Questions and Answers

What type of adverse effect is considered an Unexpected Adverse Device Effect?

Any minor adverse effect on health or safety

Any serious adverse effect on health or safety not previously identified (correct)

Any known adverse effect listed in the investigational plan

Any common side effect expected from the device

Which term refers to the absence of a significant difference in drug availability at the site of action in pharmaceutical equivalents or alternatives?

Pharmacodynamics

Bioequivalence (correct)

Pharmacokinetics

Pharmacovigilance

What is the main purpose of In Vitro Diagnostic?

Monitoring environmental pollution

Detecting diseases within living organisms (correct)

Conducting drug trials on human subjects

Analyzing tissue samples post-surgery

What is the consequence of prohibited interstate commerce and transport of adulterated food and drugs?

Seizure of questionable products and/or prosecution of responsible parties Signup and view all the answers

Which characteristic defines a finished dosage form?

Contains an active drug ingredient, possibly with inactive ingredients Signup and view all the answers

What constitutes an Unexpected Serious Problem associated with a medical device?

An unanticipated serious issue related to patient rights, safety, or welfare Signup and view all the answers

What type of device is a liquid-filled teething ring for infants?

Class 2 Signup and view all the answers

Which study is typically conducted first in the clinical development plan for an investigational antihypertensive drug?

Single dose escalation PK study in healthy volunteers Signup and view all the answers

What is the responsibility of the US Agent for a Foreign Establishment regarding medical devices?

Report adverse events under the Medical Device Reporting regulation Signup and view all the answers

The Office of Combination Products (OCP) is part of the FDA.

True Signup and view all the answers

Under which Congressional Act does the FDA have statutory authority to regulate medical devices?

Medical Device Amendments of 1976 (MDA) Signup and view all the answers

What is required for a biological product to be demonstrated as "biosimilar" under the BPCI Act?

Data showing it is "highly similar" to an already approved product Signup and view all the answers

What does the Device History Record contain?

The device's production history Signup and view all the answers

What does Design Control 'verification' require for a product's design?

The product design meets the intended use requirements Signup and view all the answers

'Dental floss' would fall under which class of device?

Class 1 Signup and view all the answers

What incentives are provided under 21 CFR 316 for the developer of an orphan product?

Tax credits for clinical research and market exclusivity Signup and view all the answers

Which of the following is typically included in a reminder advertisement for a drug product?

Brand and generic names Signup and view all the answers

What must an FDA inspector present when arriving at a facility?

Form FDA 482 and credentials Signup and view all the answers

Which of the following is a requirement for foreign manufacturers wishing to market medical devices in the U.S.?

Sponsoring a 510(k) premarket notification for a medical device Signup and view all the answers

What is NOT a responsibility of Institutional Review Boards?

Giving informed consent to subjects Signup and view all the answers

What should the Director of Regulatory Affairs at the contract sterilizer firm do if they don't find device listing forms for commercially available devices?

Begin the process of completing the missing forms Signup and view all the answers

Which statement is true regarding foreign establishments' products imported into the U.S.?

They have to comply with FDA regulations Signup and view all the answers

What action should be taken if a foreign manufacturer wants to sponsor a 510(k) premarket notification for a medical device in the U.S.?

Understand that they cannot sponsor a 510(k) premarket notification Signup and view all the answers

What should be done if there are no records of device listing forms for commercially available devices at the sterilizer firm?

Improve record-keeping practices to avoid future issues Signup and view all the answers

As a contract sterilizer, which of the following actions is correct regarding Device Listing forms?

Contract sterilizers are not required to submit Device Listing forms for the devices they manufacture. Signup and view all the answers

If a regulatory affairs professional receives evidence of criminal tampering of their firm's product resulting in deaths, what action should they take?

Initiate a Market Withdrawal. Signup and view all the answers

An acupuncture needle is classified as which type of medical device?

Class 2 Signup and view all the answers

According to the Quality System Regulation (QSR), which of the following records are subject to Document Controls?

All of the above: DHF, DMR, and DHR Signup and view all the answers

Which of the following changes to a marketed product would be considered a 'Changes Being Effected-30 days' supplement?

Change in site of testing from one facility to another Signup and view all the answers

According to the provided information, which statement is correct regarding Device Listing forms for foreign manufacturers?

Contract sterilizers should exclude devices from foreign manufacturers from their Device Listing forms. Signup and view all the answers

Study Notes

Unexpected Adverse Device Effects

An Unexpected Adverse Device Effect (UADE) refers to any serious adverse effect that is not included in the product's labeling or previously reported.

Term for Drug Availability

Bioequivalence denotes the absence of a significant difference in the availability of an active drug ingredient or active moiety at the site of action between pharmaceutical equivalents or alternatives.

Purpose of In Vitro Diagnostic

The main purpose of In Vitro Diagnostic (IVD) devices is to analyze samples (such as blood or tissue) to determine health conditions, diseases, or infections.

Consequences of Prohibited Interstate Commerce

Engaging in prohibited interstate commerce of adulterated food and drugs can lead to severe penalties including fines, product seizure, and legal action against the violators.

Characteristic of Finished Dosage Form

A finished dosage form is characterized by its final formulation, including the medication's form (e.g., tablet, liquid) that is ready for administration to patients.

Unexpected Serious Problems with Medical Devices

An Unexpected Serious Problem associated with a medical device is an occurrence that can lead to serious injury or death and is not disclosed in the device's labeling.

Type of Device for Liquid-Filled Teething Ring

A liquid-filled teething ring for infants is classified as a Class I medical device due to its low risk to users.

First Study in Clinical Development Plan

A Phase I clinical trial is typically the first study conducted in the clinical development plan for investigational antihypertensive drugs, focusing on safety and dosage.

US Agent Responsibility for Foreign Establishments

The US Agent for a Foreign Establishment is responsible for communication with the FDA on behalf of the foreign manufacturer regarding medical devices.

Office of Combination Products (OCP)

The Office of Combination Products is part of the FDA and oversees products made from a combination of drugs, devices, and biologics.

Congressional Act for Medical Device Regulation

The FDA has statutory authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act.

Requirements for Biological Products as "Biosimilar"

To be considered "biosimilar" under the BPCI Act, a biological product must demonstrate similarity in structure, biological activity, safety, and efficacy to a previously approved product.

Device History Record Contents

The Device History Record contains documentation detailing the manufacturing, processing, packaging, labeling, and testing of a medical device.

Design Control 'Verification' Requirement

Design control 'verification' checks whether a product's design meets specified requirements through testing or other evaluation methods.

Classification of Dental Floss

Dental floss is classified as a Class I medical device, as it poses minimal risk to health.

Incentives for Orphan Product Developers

Developers of orphan products receive incentives under 21 CFR 316, which may include tax credits, grant funding, and exclusive rights for a certain period.

Reminder Advertisements for Drugs

Reminder advertisements for drug products typically include the name of the drug and its purpose, without presenting information about indications or risks.

FDA Inspector Presentation

An FDA inspector must present credentials and written notice of inspection upon arriving at a facility to initiate an inspection.

Foreign Manufacturers Marketing in the U.S.

Foreign manufacturers wishing to market medical devices in the U.S. are required to have a US Agent and comply with FDA registration and listing requirements.

Institutional Review Boards Responsibilities

Institutional Review Boards (IRBs) do not primarily manage financial operations or provide funding for studies.

Action by Director of Regulatory Affairs

If the Director of Regulatory Affairs at a contract sterilizer firm cannot find device listing forms, they should conduct a thorough search and verify all records pertaining to commercially available devices.

Statement on Foreign Establishments' Products

All products imported into the U.S. from foreign establishments must comply with FDA regulations and may be subject to inspection.

Sponsorship for 510(k) Notification

A foreign manufacturer seeking to sponsor a 510(k) premarket notification must appoint a US Agent to facilitate communication with the FDA.

Device Listing Forms at Sterilizer Firm

If no records of device listing forms exist, the sterilizer firm should consult with relevant stakeholders to ensure compliance and rectify record-keeping.

Correct Actions for Contract Sterilizers

Contract sterilizers are required to maintain accurate Device Listing forms for all devices they process or sterilize.

Action for Criminal Tampering Evidence

Upon receiving evidence of criminal tampering resulting in deaths, the regulatory affairs professional must report the information immediately to appropriate authorities and cooperate in the investigation.

Acupuncture Needle Classification

An acupuncture needle is classified as a Class II medical device due to its intended use and potential risks.

Quality System Regulation Document Controls

Records subject to Document Controls under the Quality System Regulation (QSR) include design history files, device history records, and corrective action reports.

'Changes Being Effected-30 Days' Supplement

A moderate change to a marketed product that doesn't significantly affect its safety or efficacy is considered 'Changes Being Effected-30 Days' supplement, requiring notification to the FDA.

Device Listing Forms for Foreign Manufacturers

Foreign manufacturers must ensure that their device listing forms are complete and up-to-date as part of the requirements for compliance with FDA regulations.

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Description

Test your knowledge on in vitro diagnostic tests and food & drug regulations by answering true or false questions related to these topics. The quiz covers concepts such as prohibited interstate commerce of adulterated food and drugs, unexpected adverse device effects, and more.