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
A biosimilar manufacturer must demonstrate which three attributes to FDA to obtain approval under the Biologics Price Competition and Innovation Act (BPCIA)?
Answer: Analytical similarity, clinical safety, and efficacy
Biosimilar approval requires a totality-of-evidence showing analytical similarity to the reference product, along with clinical pharmacology (PK/PD) and safety/efficacy data sufficient to extrapolate or confirm equivalence.
Under ISO 13485:2016, what is the key difference in requirements compared to ISO 9001:2015 for medical device companies?
Answer: ISO 13485 requires documented procedures for virtually all quality system processes, reflecting the regulated environment
ISO 13485 maintains stricter documentation requirements than ISO 9001 because medical device regulations globally require documented evidence of conformance, reflecting the patient safety stakes.
A regulatory affairs professional reviews a proposed label claim for a diagnostic device. The claim states 99% sensitivity. Which type of study data is most critical to support this claim for FDA clearance?
Answer: Clinical performance study data comparing against a reference standard
Sensitivity and specificity claims for diagnostic devices require clinical performance data comparing results against a well-characterized reference standard or comparator method.
What is the purpose of a Risk Management File (RMF) in medical device development under ISO 14971?
Answer: To compile all risk management activities, analyses, and decisions across the product lifecycle
The Risk Management File is the compilation of all documents generated and maintained throughout the risk management process, providing traceability from hazard identification through risk evaluation and control.
When a pharmaceutical sponsor transfers a clinical trial from one country to another, which regulatory body's requirements take precedence for subject protection and data integrity in the receiving country?
Answer: The receiving country's national regulatory authority requirements
Clinical trials must comply with the regulatory requirements of the country in which the trial is being conducted, including national laws, ethics review, and GCP requirements.
Under FDA's 21st Century Cures Act provisions, which pathway was created to expedite review of regenerative medicine therapies including certain cell and gene therapies?
Answer: Regenerative Medicine Advanced Therapy (RMAT) designation
The RMAT designation was created by the 21st Century Cures Act to accelerate development and review of regenerative medicine therapies that treat serious conditions with preliminary clinical evidence of potential to address unmet needs.
A company is developing a software-only product that analyzes radiology images to prioritize worklists. FDA considers this product to be which type of regulated entity?
Answer: Software as a Medical Device (SaMD)
Software intended to analyze medical images and inform clinical decisions meets the IMDRF definition of SaMD and is subject to FDA device regulation based on its risk classification.