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A series of multiple choice questions and answers related to fda regulations for medical devices. It covers various aspects of device regulation, including premarket notification, quality systems, and good manufacturing practices. The questions and answers provide insights into key regulatory requirements and best practices for medical device manufacturers.
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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
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies - ANS-B) Vaccines
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - ANS-C) HIV diagnostic test kit
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
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
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)
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
A) Declare device substantially equivalent
B) Declare device not substantially equivalent
D) 21 CFR 812 IDE Exemptions - ANS-C) 21 CFR 807 Establishment Registration
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
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.
B. Sponsor
C. Investigator
D. IRB - ANS-D. IRB
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
A. Product Complaints
B. Batch Production Record documentation corrections
C. Returned Drug Products
D. Drug Product Salvaging - ANS-B. Batch Production Record documentation corrections
A. Issuing unique identification to all major manufacturing equipment
B. Manufacturing drug products
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
A. Animal Care
B. Laboratory Tests
C. Data Handling, Storage and Retrieval
D. Management of Publications - ANS-D. Management of Publications
A. Application Integrity Policy
B. Seizure
C. Injunction
D. Disgorgement - ANS-A. Application Integrity Policy
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
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
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
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
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.
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
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
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
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
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
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
A. Establishment Registration
B. Pre-market Approval Application
C. Quality System Regulation
D. Device Listing - ANS-B. Pre-market Approval Application
A. Establishment Registration
B. Pre-market Approval Application
C. Quality System Regulation
D. Device Listing - ANS-B. Pre-market Approval Application
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
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
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
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
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
A) Brand and generic names
B) Indication(s)
C) Dose information
D) Statement of efficacy - ANS-A) Brand and generic names
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
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
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) Carton
B) Shrink Wrapper
C) Shipping Package
D) Immediate Container - ANS-D) Immediate Container