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 medical device company receives a complaint about a device failure that resulted in patient hospitalization. Under 21 CFR Part 803, what is the required reporting timeframe for this MDR to FDA?
Answer: 30 calendar days
Medical Device Reports (MDRs) for events that caused or could have caused serious injury or death must be submitted to FDA within 30 calendar days of becoming aware of the event.
What is the primary regulatory purpose of a Drug Master File (DMF) submitted to FDA?
Answer: To provide confidential detailed information about facilities, processes, or articles used in manufacturing
A DMF allows a holder to supply confidential information to FDA to support an IND, NDA, ANDA, or other submission without disclosing proprietary information to the referencing applicant.
Under the EU MDR (2017/745), which classification rule typically applies to an implantable device intended to be in long-term contact with the cardiovascular system?
Answer: Class III
Under EU MDR, implantable devices in contact with the cardiovascular system or central nervous system are typically classified as Class III due to the highest risk level.
A company wants to make a major manufacturing change to an approved NDA product. Which type of supplement must typically be submitted and approved before implementing the change?
Answer: Prior Approval Supplement (PAS)
Major changes to an approved NDA that have a substantial potential to adversely affect product identity, strength, quality, purity, or potency require a Prior Approval Supplement (PAS) approved before implementation.
In the context of IND applications, what does the term 'clinical hold' mean?
Answer: FDA's order to delay or suspend a clinical investigation
A clinical hold is an FDA order that delays the initiation of a proposed clinical study or suspends an ongoing study due to identified safety concerns or regulatory deficiencies.
During design verification of a medical device, what is being assessed?
Answer: Whether design outputs meet the design input requirements
Design verification confirms that the design output (specifications, drawings) meets the design input requirements through testing, analysis, or inspection.
Which ICH guideline specifically addresses the stability testing requirements for new drug substances and products intended for registration in the US, EU, and Japan?
Answer: ICH Q1A(R2)
ICH Q1A(R2) provides guidance on the stability data package for new drug substances and products for registration applications submitted in ICH regions.