Podcast Beta
Questions and Answers
What type of adverse effect is considered an Unexpected Adverse Device Effect?
Which term refers to the absence of a significant difference in drug availability at the site of action in pharmaceutical equivalents or alternatives?
What is the main purpose of In Vitro Diagnostic?
What is the consequence of prohibited interstate commerce and transport of adulterated food and drugs?
Signup and view all the answers
Which characteristic defines a finished dosage form?
Signup and view all the answers
What constitutes an Unexpected Serious Problem associated with a medical device?
Signup and view all the answers
What type of device is a liquid-filled teething ring for infants?
Signup and view all the answers
Which study is typically conducted first in the clinical development plan for an investigational antihypertensive drug?
Signup and view all the answers
What is the responsibility of the US Agent for a Foreign Establishment regarding medical devices?
Signup and view all the answers
The Office of Combination Products (OCP) is part of the FDA.
Signup and view all the answers
Under which Congressional Act does the FDA have statutory authority to regulate medical devices?
Signup and view all the answers
What is required for a biological product to be demonstrated as "biosimilar" under the BPCI Act?
Signup and view all the answers
What does the Device History Record contain?
Signup and view all the answers
What does Design Control 'verification' require for a product's design?
Signup and view all the answers
'Dental floss' would fall under which class of device?
Signup and view all the answers
What incentives are provided under 21 CFR 316 for the developer of an orphan product?
Signup and view all the answers
Which of the following is typically included in a reminder advertisement for a drug product?
Signup and view all the answers
What must an FDA inspector present when arriving at a facility?
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.?
Signup and view all the answers
What is NOT a responsibility of Institutional Review Boards?
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?
Signup and view all the answers
Which statement is true regarding foreign establishments' products imported into the U.S.?
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.?
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?
Signup and view all the answers
As a contract sterilizer, which of the following actions is correct regarding Device Listing forms?
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?
Signup and view all the answers
An acupuncture needle is classified as which type of medical device?
Signup and view all the answers
According to the Quality System Regulation (QSR), which of the following records are subject to Document Controls?
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?
Signup and view all the answers
According to the provided information, which statement is correct regarding Device Listing forms for foreign manufacturers?
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
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.
