RAC Premarket Submission Pathways Questions and Answers

Question 1

A medical device manufacturer has developed a novel device for diagnosing a rare neurological condition.
There is no legally marketed predicate device available.
The device presents a low-to-moderate risk profile.
Which of the following premarket submission pathways is the most appropriate for this device?

Accepted Answer

De Novo Classification Request

Answer

Premarket Approval (PMA)

Answer

Premarket Notification (510(k))

Answer

Humanitarian Device Exemption (HDE)

Question 2

A company is planning to market a new cardiac stent, a life-sustaining device that will be permanently implanted. This type of device is considered high-risk (Class III). Which submission pathway to the FDA will be required?

Accepted Answer

Premarket Approval (PMA)

Answer

Premarket Notification (510(k))

Answer

De Novo Classification Request

Answer

Investigational Device Exemption (IDE)

Question 3

The central principle of a Premarket Notification (510(k)) submission is demonstrating:

Accepted Answer

Substantial equivalence to a predicate device

Answer

Novelty and innovation

Answer

Cost-effectiveness compared to existing treatments

Answer

Probable benefit outweighs the risk of use

Question 4

A manufacturer develops a device intended to treat a condition that affects fewer than 8,000 people in the United States annually. Due to the small patient population, conducting large-scale clinical trials to prove effectiveness is not feasible. Which pathway offers a potential route to market for such a device?

Accepted Answer

Humanitarian Device Exemption (HDE)

Answer

Abbreviated 510(k)

Answer

De Novo Classification Request

Answer

Product Development Protocol (PDP)

Question 5

A company modifies its previously cleared 510(k) device. The change involves a minor alteration to the user interface software that does not affect the device's intended use, fundamental scientific technology, or safety and effectiveness. Which of the following is the most appropriate course of action?

Accepted Answer

Document the change in the Design History File and assess if a new 510(k) is needed.

Answer

Submit a new Premarket Approval (PMA) application.

Answer

Submit a De Novo request for the modified device.

Answer

Immediately recall the product from the market.

Question 6

Which of the following statements BEST distinguishes the Premarket Approval (PMA) pathway from the 510(k) pathway?

Accepted Answer

The PMA pathway requires a demonstration of safety and effectiveness through clinical data, whereas a 510(k) relies on substantial equivalence to a predicate.

Answer

A 510(k) results in an 'approval' letter, while a PMA results in a 'clearance' letter.

Answer

510(k) submissions are only for Class I devices, while PMA submissions are for Class II and III devices.

Answer

The standard review timeline for a 510(k) is 180 days, whereas for a PMA it is 90 days.