CRAP Product Development & Compliance 3 — Questions and Answers
Question 1: Under 21 CFR Part 312, a Phase 2 clinical investigation is primarily intended to accomplish which objective?
- Establish maximum tolerated dose in healthy volunteers
- Evaluate effectiveness and identify common short-term side effects (Correct answer)
- Confirm efficacy in large multicenter trials
- Conduct post-approval safety studies
Correct answer: Evaluate effectiveness and identify common short-term side effects
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?
- Only when the new device uses new technology
- When the device is classified as Class II and no exemption applies (Correct answer)
- Only for Class III devices that require clinical data
- Only when the predicate device was cleared after 1990
Correct answer: When the device is classified as Class II and no exemption applies
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?
- ISO 10993-1 (Correct answer)
- ASTM F2132
- ISO 14155
- EN 62366
Correct answer: ISO 10993-1
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?
- Software as a Medical Device (SaMD) Guidance 2017
- Artificial Intelligence and Machine Learning-Based Software as a Medical Device Action Plan (Correct answer)
- De Novo Classification Process Guidance
- Digital Health Center of Excellence Framework
Correct answer: Artificial Intelligence and Machine Learning-Based Software as a Medical Device Action Plan
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?
- To compare two competing drug products for therapeutic equivalence
- To justify future manufacturing changes with less regulatory oversight (Correct answer)
- To establish biosimilarity between a proposed biosimilar and reference product
- To document raw material supplier qualification
Correct answer: To justify future manufacturing changes with less regulatory oversight
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.
Question 6: A usability engineering file for a medical device must demonstrate compliance with which standard to satisfy EU MDR usability requirements?
- IEC 60601-1
- IEC 62366-1 (Correct answer)
- ISO 13485
- ISO 14971
Correct answer: IEC 62366-1
IEC 62366-1 specifies a process for manufacturers to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety.
Question 7: Which term describes the set of conditions and ranges established during pharmaceutical development within which operation produces a product meeting quality standards, as defined in ICH Q8?
- Control Strategy
- Design Space (Correct answer)
- Normal Operating Range
- Critical Process Parameter
Correct answer: Design Space
The Design Space is the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.
CRAP Product Development & Compliance 3
Under 21 CFR Part 312, a Phase 2 clinical investigation is primarily intended to accomplish which objective?