Quiz: FDA Submission Types
What is a 510(k) submission? A) A request for an Investigational Device Exemption B) A premarket notification to demonstrate substantial equivalence to a legally marketed device C) A submission for premarket approval of Class III devices D) A request for Humanitarian Device Exemption
B Explanation: A 510(k) submission is a premarket notification that demonstrates that a new medical device is substantially equivalent to a legally marketed device.
What is the purpose of a 513(g) Request for Information? A) To gain approval for a new drug-device combination B) To seek the FDA's opinion on the classification of a device C) To apply for a Humanitarian Device Exemption D) To report adverse events
B Explanation: A 513(g) request allows manufacturers to seek the FDA's opinion on the classification of their device.
What is the purpose of an Investigational Device Exemption (IDE)? A) To classify a novel device into Class I or II B) To allow an unapproved device to be used in clinical trials C) To submit for a premarket notification D) To report changes in a previously approved device
B Explanation: A De Novo classification request allows for low- to moderate-risk devices that are novel and not substantially equivalent to any existing device to gain marketing authorization.
What distinguishes a Modular PMA from a Traditional PMA?A) A Modular PMA cannot be submitted for Class III devices B) A Modular PMA allows for sequential submission of data sections C) A Modular PMA requires no clinical data D) A Modular PMA is only for combination products
B Explanation: A Modular PMA allows manufacturers to submit sections of the application sequentially, enabling the FDA to review parts of the submission as they are completed, rather than waiting for the entire submission.
Which submission type is used to inform the FDA about significant changes to a previously cleared or approved device? A) PMA B) Notification of Change C) 510(k )D) IDE
B Explanation: A Notification of Change is submitted to inform the FDA about significant changes that could affect the safety or effectiveness of a previously cleared or approved device.
Which submission type requires a rigorous clinical trial process to demonstrate safety and effectiveness? A) 510(k) B) PMA (Premarket Approval) C) De Novo classification D) 513(g) Request for Information
B Explanation: A PMA submission is required for Class III devices and necessitates comprehensive clinical trials to demonstrate safety and effectiveness.
What is a Special 510(k)? A) A submission for a device that has never been marketed before B) A submission for changes to an already cleared device that do not significantly affect safety or effectiveness C) A 510(k) submission for high-risk devices D) A submission for devices that require extensive clinical trials
B Explanation: A Special 510(k) is used for modifications to a device that do not significantly affect its safety or effectiveness, allowing for a more straightforward review process compared to a Traditional 510(k).
What is a Special PMA? A) A PMA for devices that are substantially equivalent to existing products B) A PMA for devices used in humanitarian applications C) A PMA for devices requiring less stringent evidence of effectiveness D) A PMA for devices intended for research purposes
B Explanation: A Special PMA is for devices intended to treat or diagnose rare diseases or conditions affecting fewer than 8,000 patients in the U.S. annually, following a Humanitarian Device Exemption process.
What is the primary focus of a Traditional 510(k)? A) To demonstrate clinical effectiveness B) To show substantial equivalence to a predicate device C) To allow for device changes without notification D) To obtain premarket approval for Class III device
B Explanation: A Traditional 510(k) focuses on demonstrating substantial equivalence to a predicate device, allowing the new device to be marketed based on the existing device's safety and effectiveness.
Which of the following best describes an Abbreviated 510(k)? A) It requires a full clinical study report. B) It allows for reliance on FDA guidance documents and recognized standards. C) It is for Class III devices only. D) It involves a modular submission process.
B Explanation: An Abbreviated 510(k) submission allows manufacturers to rely on FDA guidance documents and recognized consensus standards to demonstrate substantial equivalence, streamlining the review process.
A Humanitarian Device Exemption (HDE) is designed for which of the following? A) Devices intended for common conditions affecting a large population B) Devices for rare diseases affecting fewer than 8,000 individuals annually C) Devices requiring comprehensive clinical trials D) Devices needing a 510(k) submission
B Explanation: An HDE is a regulatory pathway for devices intended to treat or diagnose conditions affecting fewer than 8,000 individuals in the U.S. annually
Which of the following is NOT a subtype of Premarket Approval (PMA)? A) Traditional PMA B) Simplified PMA C) Real-Time PMA D) Modular PMA
B Explanation: The subtypes of PMA include Traditional PMA, Modular PMA, and others, but there is no "Simplified PMA." The Traditional PMA is the standard submission process, while Modular PMA allows submission of sections over time.
What is the primary requirement for a PMA submission? A) Demonstration of substantial equivalence B) Evidence of safety and effectiveness through clinical trials C) Notification of changes in the device D) Request for Investigational Device Exemption
B Explanation: A PMA submission requires comprehensive data, including clinical study results, to demonstrate the safety and effectiveness of Class III medical devices.
Which of the following is true regarding the 510(k) pathway?A) It is exclusively for Class III devices. B) It requires demonstration of clinical trials for all submissions. C) It is typically faster than the PMA pathway for market entry. D) It is only applicable for devices that have a human use component.
C Explanation: The 510(k) pathway is generally faster than the PMA pathway for market entry because it relies on demonstrating substantial equivalence to an already marketed device rather than requiring extensive clinical trials.
