US RAC Review Questions RAPS Modules
73) Which of the following is an example of a "Changes Being Effected" supplement? A) Add/strengthen a contraindication, warning B) Change in specifications to comply with an official compendium C) Editorial change D) Deletion or reduction of an ingredient to affect color
A) Add/strengthen a contraindication, warning
60) 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
A) Brand and generic names
72) 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
A) Brand and generic names
85) Dental floss is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
A) Class 1
87) A non-powered microsurgical instrument for use in neurological microsurgery procedures is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
A) Class 1
89) Non-prescription sunglasses are an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) No way is this a device
A) Class 1
8) If FDA were to invoke the Application Integrity Policy, which of the following is a possible outcome? A) Defer review of pending application(s) B) "File" a marketing application at the 60 day review C) Grant a waiver or deferral for pediatric clinical study D) Approve a marketing application
A) Defer review of pending application(s)
33) 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)
A. Doctor of Pharmacy (PharmD) Only PharmD does not treat patients MD, DDS, DO - all treat patients
77) When an FDA inspector arrives at a facility, he or she must present is A) Form FDA 482 and credentials B) EIR C) Form FDA 483 and Notice of Inspection D) Form FDA 484
A) Form FDA 482 and credentials
13) 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.
A) Report adverse events under the Medical Device Reporting regulation
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
A) Request Special Protocol Assessment
65) You, a regulatory affairs professional, are in a situation where an administrative or procedural dispute has occurred between the sponsor and the FDA reviewing division. In attempt to resolve the dispute, on what level would you initially try to resolve the dispute? A) Review Division B) Agency Ombudsman C) Office Director D) FDA Office of Regulatory Affairs
A) Review Division
70) Which of the following examples best represents "fair balance"? A) Risks and benefits are presented in comparable prominence, readability B) A reminder ad C) Established name appears next to brand name in type at least 50% of brand name D) Advertising directed to physicians and consumers
A) Risks and benefits are presented in comparable prominence, readability
31) 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
A. Application Integrity Policy
41) 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
A. Critical component manufacturers
23) 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
A. Results of internal audit findings are required to be provided to the FDA Inspectors upon request
52) 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
A. Substantially equivalent to a pre-amendment device
You, a regulatory affairs professional, are assessing the information to be submitted in support of a marketing application for a new dosage form for a listed drug. You lack right of reference to one key preclinical report. Which type of application will you prepare for submission? A) 505 (b) (1) B) 505 (b) (2) C) 505 (j) D) PMA
B) 505 (b) (2)
83) An OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks is an example of what type of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
B) Class 2
84) An liquid-filled teething ring (for use by infants) is an example of what type of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
B) Class 2
86) An acupuncture needle is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
B) Class 2
90) A male condom is an example of what class of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
B) Class 2
81) The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported. A) Manufacturers B) Distributors C) Initial importers D) User facilities
B) Distributors
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 D) Provide appropriate clinical summary
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
76) Which of the following is true regarding ICH guidelines? A) ICH guidelines represent the joint opinions of regulatory agencies in US, Europe and Japan. B) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe and Japan. C) ICH guidelines represent the joint opinions of the pharmaceutical industry in US, Europe and Japan. D) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe, Canada and Japan
B) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe and Japan.
80) Which of the following medical device types are not subject to Manufacturer tracking: A) Life-sustaining or life-supporting device used outside of a device-user facility B) Life-sustaining or life-supporting device used inside of a device-user facility C) Permanently implantable device D) Devices sold to a distributor for ultimate delivery (sale) to end-user
B) Life-sustaining or life-supporting device used inside of a device-user facility
82) Which of the following conditions may be expected to lead to a field recall action? A) Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of Federal Food, Drug & Cosmetic Act B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection C) Stock Recovery of a device has not left direct control of manufacturer D) Routine servicing
B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection
56) As the sponsor of an approved drug product, you receive information that your distributed product is exhibiting unexpected properties suggesting chemical, physical, or bacteriological change. You are required to report this information as follows: A) Within 7 calendar days to the local FDA district office B) Within 3 working days to the local FDA district office C) In the annual report D) Within 15 calendar days to reviewing FDA office
B) Within 3 working days to the local FDA district office
57) The following are objectives of a pre-approval inspection except: A) Assess cGMP compliance B) Scientific review of data to assess safety and efficacy C) Collect samples for analysis by FDA D) Verify accuracy of data submitted in an application
B) Scientific review of data to assess safety and efficacy
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
B) Single dose escalation PK study in healthy volunteers
78) Your company wants to conduct a small exploratory study for an alternate dosing regimen for an approved drug/approved indication. As a Regulatory Affairs professional, your first advice is: A) The results of the study may potentially be useful to support a label change B) The study must be conducted under an IND C) You cannot conduct the study unless you intend to pursue a label change D) Increase the size of the study in order to demonstrate statistical significance
B) The study must be conducted under an IND
10) Which of the following products would not be regulated by CDER? A) Therapeutic proteins B) Vaccines C) Chemically synthesized small molecules D) Monoclonal antibodies
B) Vaccines
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
B) to FDA and investigators within 7 calendar days
35) An FDA Form 1572 Statement of the Investigator should be revised for all of the following except: A. A change in the principal investigator for the study B. A change in sponsor medical monitor for the study C. The addition of a local lab or health care facility to which the study patients make visits D. A change in the IRB or the IRB's name
B. A change in sponsor medical monitor for the study The FDA Form 1572 does not include a section for the documentation of sponsor medical monitor. Medical Monitor information is captured in FDA Form 1571.
32) 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
B. Accessible to all facility personnel
24) 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
B. Batch Production Record documentation corrections
39) 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
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.
43) 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
B. Design and development plans address how design inputs and requirements are managed
20) 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
B. Devices or their components
27) According to GMPs, the following product labels should be rejected except which of the following: A. Labeling and packaging materials that do not meet the approved specifications B. Labeling and packaging materials that remain at the end of a production shift C. Obsolete and outdated labels D. Gang printed labeling that is not differentiated by size, shape or color
B. Labeling and packaging materials that remain at the end of a production shift
29) 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
B. Maintenance of the master schedule
50) 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
B. Pre-market Approval Application
51) 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
B. Pre-market Approval Application
38) Under the official definition of a "device", all of the following are considered devices except: A. X-ray film B. Sterilizers used for device manufacturing C. Eyeglass lenses and frames D. In vitro diagnostic kit
B. Sterilizers used for device manufacturing
11) 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
C) HIV diagnostic test kit
59) 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
C) Incorrect lot number on the label
19) The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except: A) 21 CFR 50 Protection of Human Subjects B) 21 CFR 56 IRB C) 21 CFR 807 Establishment Registration D) 21 CFR 812 IDE Exemptions
C) 21 CFR 807 Establishment Registration
75) For a marketed product, which of the following is not an example of a "prior approval" supplement? A) Manufacturing process change B) Change impacting product sterility C) Add a precaution to label D) Delete specification for drug substance
C) Add a precaution to label
61) 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
C) Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA
63) 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
C) Cease dissemination of violative materials
88) A female condom is an example of what class of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device
C) Class 3
66) The FDA wants to develop a new guidance document on electronic submissions. Initially, the best way for FDA to obtain industry input for the preparation of a first draft is to A) Schedule an advisory panel meeting B) Announce a public hearing on the issue C) Conduct talks with a number of trade associations D) Issue a Federal Register notice of intent to promulgate a guidance document
C) Conduct talks with a number of trade associations
68) ADEs that do not meet 15-day reporting requirements should be reported by the applicant: A) Annually, unless alternate reporting arrangement is required by FDA B) Semi-annually, unless alternate reporting arrangement is required by FDA C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA D) Quarterly for 1st year after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA
C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA
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
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information
54) 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. B. As a contract sterilizer, my facility does not need to register. C. As a foreign establishment, my firm is required to register. D. The Establishment Registration fee is waived for small companies
C. As a foreign establishment, my firm is required to register.
55) You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct? A. Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes. B. Exclude devices from foreign manufacturers from the list being prepared above. C. Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.
C. Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.
40) 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
C. Finished devices and accessories to finished devices
21) 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
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.
42) 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
C. Management must review the Quality System at least quarterly
44) Design Control "verification" requires which of the following: A. The product design meets the users needs B. The process produces a product that meets predetermined specifications C. The product design meets specified requirements D. The product design meets the intended use requirements
C. The product design meets specified requirements
67) Which of the following best describes Advisory Committee meetings? A) Advisory Committee meetings are always open to the public B) Advisory Committee meetings only occur in the product approval stage C) FDA must follow resulting recommendations of Advisory Committee D) Advisory Committee meetings are a way for FDA to consult with outside experts
D) Advisory Committee meetings are a way for FDA to consult with outside experts
62) 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
D) All of the above
16) 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 C) State a 510(k) is not required to market the device D) Approve the device for market
D) Approve the device for market
74) For a marketed product, which of the following is an example of a "Changes Being Effected-30 days" supplement? A) Deletion or reduction of an ingredient to affect color B) New analytical method C) Addition of an alternate analytical method D) Change in site of testing from one facility to another
D) Change in site of testing from one facility to another
12) 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
D) Check the FDA website for information, eg, other combination/similar products
71) Which of the following is not found in the Orange Book? A) Patent information for approved drug products B) Exclusivity information for approved drug products C) Information related to therapeutic equivalence for approved drug products D) Drugs on the market approved only on the basis of safety or pre-1938 drugs
D) Drugs on the market approved only on the basis of safety or pre-1938 drugs
79) Which of the following best represents the Quality Systems Inspection Technique? A) Focus on Manufacturing and Manufacturing Processes B) Focus on QC testing and Product Release C) Focus on Batch Record Review D) Focus on Management
D) Focus on Management
14) 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)
D) Medical Device Amendments of 1976 (MDA)
15) 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
D) IDE, Investigational Device Exemptions, Part 812
64) A label is defined as that which is affixed to the: A) Carton B) Shrink Wrapper C) Shipping Package D) Immediate Container
D) Immediate Container
58) 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
D) Lack of NDC on label
69) As a regulatory affairs professional, you are provided evidence that your firm's product has been the subject of criminal tampering post-distribution which has resulted in 2 known deaths. You assemble the appropriate internal team in order to implement a A) Class I Recall B) Class II Recall C) Class III Recall D) Market Withdrawal
D) Market Withdrawal
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
D) Phase III pivotal study
9) Which of the following supplements to an approved NDA/BLA must be approved by FDA prior to distributing product made using the change? A) Make change(s) to comply with USP B) Change in the technical grade of an excipient, same specifications and use C) Add a warning statement to prescribing information D) Process change outside the validated range
D) Process change outside the validated range
18) With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial? A) Informed consent of trial participants B) IRB approval of the trial C) Financial disclosure by investigators D) Submission of the trial protocol to FDA for approval
D) Submission of the trial protocol to FDA for approval
49) 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
D. All of the above
25) 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 C. Warehousing and distributing drug products D. Approving and rejecting raw materials, components, label, drug products, procedures and specifications
D. Approving and rejecting raw materials, components, label, drug products, procedures and specifications
48) 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
D. Be made aware of defects which may occur if they do not perform their job correctly
53) 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
D. Foreign manufacturers cannot sponsor a 510(k) premarket notification for a medical device
22) Who has final authority over content of an Informed Consent? A. FDA B. Sponsor C. Investigator D. IRB
D. IRB
30) 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
D. Management of Publications
26) Written procedures (SOPs) for production and process control deviation must meet all the following criteria except: A. Must exist for production and process controls B. Must assure that the drug products have the identity, strength, quality and purity C. Must be reviewed and approved by the quality control unit D. Must be written by the production function
D. Must be written by the production function
28) How often should employees receive training in GMPs? A. On an annual basis B. Semi-annually C. Annually D. On a continuing basis
D. On a continuing basis
37) Clinical protocol amendments are required for the following except: A. Increase in drug dosage or duration of subject exposure B. Addition of a new clinical investigator C. Significant change in protocol design D. Phase 1 study design changes that do not affect critical safety assessments.
D. Phase 1 study design changes that do not affect critical safety assessments.
36) Informed consent documentation must be compliant with all except the following: A. Signature of the subject or the subject's legal representative B. Revised due to new information regarding the investigational product that might affect a subject's willingness to participate in the study becomes available C. Approved by the clinical trial site IRB D. Revised due to change in contact person name and/or phone number
D. Revised due to change in contact person name and/or phone number
34) 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
D. Review and approval of clinical protocols
45) According to the QSR, Design Inputs are best described by the following: A. The Operator's Manual and instructions on how to use the device B. The Instructions For Use (IFU) of the device C. Marketing claims and features that are required for the device D. The performance requirements that the product must meet
D. The performance requirements that the product must meet
17) From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development? A) Animal use testing to validate the design of your device B) Bench testing to verify that your design performs as designed C) Biocompatibility/Toxicity testing D) Functional/Safety/Performance testing E) All of the above
E) All of the above
46) According to the QSR, Design Outputs contain the following: A. The Device Master Record (DMR) B. The documentation from the last phase of the complete Design Control process C. The test reports that support that the Design Inputs have been met D. All of the packaging and labeling associated with the finished device E. A and D above
E. A and D above A. The Device Master Record (DMR) D. All of the packaging and labeling associated with the finished device
47) According to the QSR, Quality Audits must accomplish the following: A. Meet the same requirements of the original GMP 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
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
