Download FDA Regulations for Medical Devices: Multiple Choice Questions and Answers and more Study Guides, Projects, Research Management of Health Service in PDF only on Docsity!
US RAC Review Questions RAPS Modules
Questions & Answers
In which situation is an IND not required?
A) You intend to conduct a clinical trial with an investigational new drug
B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information
D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - ANS-C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information
In the clinical development plan for an investigational antihypertensive drug, which of the following studies would typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
D) Single dose escalation study in hypertensive patients - ANS-B) Single dose escalation PK study in healthy volunteers
A sponsor must report an unexpected, fatal or life-threatening experience believed to be associated with an unapproved drug/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days - ANS-B) to FDA and investigators within 7 calendar days
Which of the following is a covered study as defined under Financial Disclosure regulations:
A) Phase I dose escalation study
B) Phase I/II Pharmacokinetic Study
C) A large open label safety study conducted at a large number of study sites
D) Phase III pivotal study - ANS-D) Phase III pivotal study
Your company is developing a product to treat a serious and life threatening disease. A clinically meaningful, well established primary endpoint will be used in the pivotal studies. Which regulatory strategy might you select prior to commencing Phase 3 studies?
A) Request Special Protocol Assessment
B) Request Fast Track Designation
C) Request Priority Review
D) Approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses - ANS-A) Request Special Protocol Assessment
As a regulatory affairs professional, you are responsible for developing the content of an information package for a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team members
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
C) Provide appropriate preclinical summary
- Which of the following products would not be regulated by CDER?
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies - ANS-B) Vaccines
- Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - ANS-C) HIV diagnostic test kit
- You are developing a combination product and believe the primary mode of action will designate the product as a drug as opposed to a device. Your first course of action is to:
A) Develop written rationale describing the product, mode(s) of action, and proposed classification as a drug
B) Submit a formal request for designation to the Office of Combination Products
C) Call the CDER review division
D) Check the FDA website for information, eg, other combination/similar products - ANS-D) Check the FDA website for information, eg, other combination/similar products
- For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - ANS-A) Report adverse events under the Medical Device Reporting regulation
- Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?
A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
C) Federal Food, Drug, Cosmetic Act (FDC Act)
D) Medical Device Amendments of 1976 (MDA) - ANS-D) Medical Device Amendments of 1976 (MDA)
- Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA?
A) 510(k), Pre-market Notification, Part 807
B) HDE, Humanitarian Device Exemption, Part 814
C) Premarket Approval (PMA), Part 814
D) IDE, Investigational Device Exemptions, Part 812 - ANS-D) IDE, Investigational Device Exemptions, Part 812
- At completion of review of a 510(k), FDA may take the following actions except:
A) Declare device substantially equivalent
B) Declare device not substantially equivalent
D) 21 CFR 812 IDE Exemptions - ANS-C) 21 CFR 807 Establishment Registration
- According to the Federal Food, Drug and Cosmetics (FD&C) Act, a drug is defined as all of the following except:
A. Recognized in the US Pharmacopoeia , Homeopathic Pharmacopoeia of the United States, or the National Formulary
B. Devices or their components
C. Intended for diagnosis, cure, mitigation, treatment or prevent of disease in humans or other animals
D. Intended to affect the structure or any function for the body of humans or other animals - ANS-B. Devices or their components
- It is acceptable for FDA forms completed and submitted by the principal investigator to support an IND submission to include the which of following:
A. Typed name in the signature block
B. Rubber stamped name in the signature block
C. Handwritten dates
D. Signature of study staff personnel on behalf of the investigator - ANS-C. Handwritten dates
Good documentation practice dictates that signatures
not be stamped, or typed in order to be legitimate and
controlled. Signatures must be written by the individual
who is responsible for the activity indicated and cannot
be delegated.
- Who has final authority over content of an Informed Consent?
A. FDA
B. Sponsor
C. Investigator
D. IRB - ANS-D. IRB
- The following are characteristics of FDA GMP inspections except:
A. Results of internal audit findings are required to be provided to the FDA Inspectors upon request
B. Biennial inspections of manufacturing facilities take place to verify compliance with regulations.
C. The FDA may inspect the drug product sponsor and any manufacturing subcontractors.
D. FDA inspections may be conducted due to serious non-compliance with GMP regulations - ANS-A. Results of internal audit findings are required to be provided to the FDA Inspectors upon request
- Management should be notified in writing of the GMP Investigations conducted for all of the following except:
A. Product Complaints
B. Batch Production Record documentation corrections
C. Returned Drug Products
D. Drug Product Salvaging - ANS-B. Batch Production Record documentation corrections
- According to GMP regulations, the quality control unit is responsible for which of the following activities:
A. Issuing unique identification to all major manufacturing equipment
B. Manufacturing drug products
- GLP study directors are required to conduct the following activities except:
A. Approving the final study reports
B. Maintenance of the master schedule
C. The protocol is approved and followed
D. Experimental data are accurately reported and verified - ANS-B. Maintenance of the master schedule
- Standard operating procedures should be generated for the following GLP activities except:
A. Animal Care
B. Laboratory Tests
C. Data Handling, Storage and Retrieval
D. Management of Publications - ANS-D. Management of Publications
- Which is a type of administrative enforcement tool that FDA may use outside of the US court system or the Department of Justice?
A. Application Integrity Policy
B. Seizure
C. Injunction
D. Disgorgement - ANS-A. Application Integrity Policy
- GLP documentation archives should have the following attributes except:
A. Appropriate for laboratory specimens
B. Accessible to all facility personnel
C. Environmentally controlled (temperature and humidity)
D. Secure with controlled access to raw data and documentation - ANS-B. Accessible to all facility personnel
- According to FDA policy, qualified individuals that are non-MDs can conduct clinical trials as long as an individual listed as a co- or sub-investigator has one of the following credentials is except:
A. Doctor of Pharmacy (PharmD)
B. Medical Doctor (MD)
C. Doctor of Dental Science (DDS)
D. Doctor of Osteopathic Medicine (DO) - ANS-A. Doctor of Pharmacy (PharmD)
Only PharmD does not treat patients
MD, DDS, DO - all treat patients
- Institutional Review Boards are responsible for conducting which of the following activities:
A. Training of clinical research staff
B. Reporting subject SAEs to the sponsor
C. Giving informed consent to subjects
D. Review and approval of clinical protocols - ANS-D. Review and approval of clinical protocols
- An FDA Form 1572 Statement of the Investigator should be revised for all of the following except:
A. X-ray film
B. Sterilizers used for device manufacturing
C. Eyeglass lenses and frames
D. In vitro diagnostic kit - ANS-B. Sterilizers used for device manufacturing
- 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except:
A. High Flux Hemodialyzer
B. Blood specimen collection device
C. Piston syringe
D. Cardiopulmonary bypass blood tubing - ANS-B. Blood specimen collection device
Premarket submissions for medical devices associated with the blood
collection and processing procedures as well as those associated with
cellular therapies are reviewed by CBER.
- CBER's expertise in blood, blood products, and cellular therapies is considered critical to the appropriate review of premarket submissions for these products.
- The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following:
A. Finished devices, but not accessories
B. Finished devices and components of finished devices
C. Finished devices and accessories to finished devices
D. Finished devices, components, and accessories to finished devices - ANS-C. Finished devices and accessories to finished devices
- The Quality System Regulation for Class III devices applies to the following except:
A. Critical component manufacturers
B. Operations done by the manufacturer at facilities located in the United States
C. Research on investigational devices tested outside of the United States
D. Contract Sterilizers - ANS-A. Critical component manufacturers
- The Quality System Regulation (QSR) for medical devices (21CFR 820) requires all of the following except:
A. Management to make a commitment to quality
B. A Quality Plan that defines how quality will be met
C. Management must review the Quality System at least quarterly
D. A Quality representative must be identified and documented - ANS-C. Management must review the Quality System at least quarterly
- The Quality System Regulation (QSR) for medical devices regarding Design Controls require which of the following:
A. Documentation of early research of the design
B. Design and development plans address how design inputs and requirements are managed
C. A product design can be outsourced by a manufacturer so they do not have to maintain the documentation
D. Design activities are only required for Class III Investigational devices - ANS-B. Design and development plans address how design inputs and requirements are managed
B. Evaluate if the Quality System is in compliance with the QSR
C. Determine the effectiveness of the Quality System
D. Focus on Design Controls and the CAPA system
E. B and C above
F. A and D above - ANS-E. B and C above
B. Evaluate if the Quality System is in compliance with the QSR
C. Determine the effectiveness of the Quality System
- According to the QSR, Personnel involved in the design, manufacture, distribution, servicing, and reporting must:
A. Be trained in their area of responsibility
B. At a minimum receive procedure training once per year in their area of responsibility
C. Be able to recite the Quality Policy, if asked
D. Be made aware of defects which may occur if they do not perform their job correctly - ANS-D. Be made aware of defects which may occur if they do not perform their job correctly
- According to the QSR, Document Controls apply to:
A. Design History File (DHF)
B. Device Master Record (DMR)
C. Device History Record (DHR)
D. All of the above - ANS-D. All of the above
- All of the following are considered General Controls under the FD&C Act except:
A. Establishment Registration
B. Pre-market Approval Application
C. Quality System Regulation
D. Device Listing - ANS-B. Pre-market Approval Application
- All of the following are considered General Controls under the FD&C Act except:
A. Establishment Registration
B. Pre-market Approval Application
C. Quality System Regulation
D. Device Listing - ANS-B. Pre-market Approval Application
- Premarket Notification Requirements would apply to a device that is:
A. Substantially equivalent to a pre-amendment device
B. Intended solely for use by a specific physician
C. Not equivalent to currently marketed devices
D. Intended for veterinary use - ANS-A. Substantially equivalent to a pre-amendment device
- Which of the following statements regarding foreign establishments wishing to market medical devices in the U.S. is incorrect?
A. Foreign manufacturers must designate a U.S. Agent
B. Foreign establishments must register in the U.S.
C. Foreign manufacturers must list all medical devices imported to the U.S.
D. Foreign manufacturers cannot sponsor a 510(k) premarket notification for a medical device - ANS-D. Foreign manufacturers cannot sponsor a 510(k) premarket notification for a medical device
- Which of the following statements regarding Establishment Registration is correct?
A. Since my medical device is manufactured by a contract manufacturer, our facility is not required to register.
C) Collect samples for analysis by FDA
D) Verify accuracy of data submitted in an application - ANS-B) Scientific review of data to assess safety and efficacy
- Which of the following is not an example of misbranding?
A) An incorrect lot number on the label
B) A drug product without a manufacturer, packer or distributor on the label
C) Font size of established name is 25% of the font size of the trade name
D) Lack of NDC on label - ANS-D) Lack of NDC on label
- Which of the following examples do not meet the definition of adulteration?
A) A bottle of aspirin (for public retail sale) that is not packaged in tamper-resistant packaging
B) Batch record was accidentally destroyed
C) Incorrect lot number on the label
D) A drug recognized in the USP/NF that does not meet all compendium standards - ANS-C) Incorrect lot number on the label
- Which of the following is typically included in a reminder advertisement?
A) Brand and generic names
B) Indication(s)
C) Dose information
D) Statement of efficacy - ANS-A) Brand and generic names
- Which of the following is a true statement regarding advertising/promotion of prescription drug products?
A) All promotional materials must be approved by FDA prior to use
B) All promotional materials must be approved by the Federal Trade Commission
C) Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA
D) Advertising is not allowed for drugs approved under accelerated approval/Subpart H - ANS-C) Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA
- Which of the following convey "intended use" for a drug product?
A) Prescribing information
B) Verbal statements by sponsor or sponsor's representative about a product's use at a trade show
C) Printed promotional materials
D) All of the above - ANS-D) All of the above
- You, a regulatory affairs professional, receive a warning letter from DDMAC pertaining to DTC advertising. The first thing you do is:
A) Develop a corrective advertisement
B) Write a response letter to DDMAC
C) Cease dissemination of violative materials
D) Review the marketing application - ANS-C) Cease dissemination of violative materials
- A label is defined as that which is affixed to the:
A) Carton
B) Shrink Wrapper
C) Shipping Package
D) Immediate Container - ANS-D) Immediate Container
