Product Development & Compliance Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Product Development & Compliance flashcards as text
Under 21 CFR Part 312, a Phase 2 clinical investigation is primarily intended to accomplish which objective?
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.
When must a 510(k) applicant demonstrate 'substantial equivalence' to a predicate device?
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.
A biocompatibility assessment for a new medical device contacting blood should follow which guidance standard?
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.
Which FDA guidance document outlines the concept of a Predetermined Change Control Plan (PCCP) for AI/ML-based software as a medical device?
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.
In pharmaceutical development, what is the purpose of a Comparability Protocol submitted to FDA?
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.
A usability engineering file for a medical device must demonstrate compliance with which standard to satisfy EU MDR usability requirements?
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.
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?
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.