CRAP Product Development & Compliance 3

Question 1

Under 21 CFR Part 312, a Phase 2 clinical investigation is primarily intended to accomplish which objective?

Accepted Answer

Evaluate effectiveness and identify common short-term side effects

Answer

Phase 2 studies evaluate whether a drug shows activity against the targeted disease and identify common short-term side effects and risks in a smaller patient population.

Question 2

When must a 510(k) applicant demonstrate 'substantial equivalence' to a predicate device?

Accepted Answer

When the device is classified as Class II and no exemption applies

Answer

Class II devices without a 510(k) exemption must demonstrate substantial equivalence to a legally marketed predicate device via the 510(k) premarket notification process.

Question 3

A biocompatibility assessment for a new medical device contacting blood should follow which guidance standard?

Accepted Answer

ISO 10993-1

Answer

ISO 10993-1 provides a framework for evaluating the biocompatibility of medical device materials, including biological evaluation planning based on nature and duration of contact.

Question 4

Which FDA guidance document outlines the concept of a Predetermined Change Control Plan (PCCP) for AI/ML-based software as a medical device?

Accepted Answer

Artificial Intelligence and Machine Learning-Based Software as a Medical Device Action Plan

Answer

FDA's AI/ML SaMD Action Plan introduced the Predetermined Change Control Plan concept, allowing developers to plan and implement modifications to AI/ML algorithms without a new submission for each update.

Question 5

In pharmaceutical development, what is the purpose of a Comparability Protocol submitted to FDA?

Accepted Answer

To justify future manufacturing changes with less regulatory oversight

Answer

A Comparability Protocol is an approved plan that allows sponsors to make specified post-approval manufacturing changes with reduced regulatory reporting requirements if the protocol tests show the change did not adversely affect the product.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Product Development & Compliance 3