Device RAC Exam Questions from Quizlet

If your firm commercially distributes a Class III device subject to PMA without an approved PMA, what is the statutory violation? A) Adulteration B) Improper Use C) Misbranding D) Idiocy

A) Adulteration

The QSR for Class III devices applies to the following except: A) Critical component manufacturers B) Operations done by mfger at facilities located in US C) Research on investigational devices tested outside of the United States D) Contract Sterilizers

A) Critical component manufacturers

FDA currently requires that all device registration and listing information (Annual, Initial or Updates) be submitted using: A) FDAs Unified Registration and Listing System B) FDA Forms 2891 and 2892 C) FDA Forms 2656 and 2657 D) FDA Form 3356

A) FDAs Unified Registration and Listing System (FURLS) According to the FDA website, the Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver. Furthermore, registration and listing information need to be submitted by using FDA's Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM). This question tests whether the examinee's knowledge on medical device establishment registration and listing is current. Only Choice ID #1 is correct. The other answers are distracters. Regulatory Reference: FDA Website: How to register and list medical device (http:/www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm).

For a medical device, what is NOT a responsibility of the US Agent for a Foreign Establishment? A) Report adverse events under the MDR regulation B) Assisting FDA in communications with foreign establishment C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States D) Assisting FDA in scheduling inspections of the foreign establishment

A) Report adverse events under the MDR regulation

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following typically occurs? A. The labeling is revised B. The product is recalled C. The product is redesigned D. A "Dear Doctor" letter is issued

A. The labeling is revised The labeling should provide appropriate information for proper use of the product.

Pre-market 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

FDA sent a warning letter citing mislabeling of a small manufacturer's artificial knee device. The regulatory affairs professional should first contact the: A. Compliance Branch in their district B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation C. Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in CDRH. D. CDRH Ombudsman

A. Compliance Branch in their district This office is the best source for further follow up.

According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record B. Device master record C. Quality manual D. Design history file

A. Device history record This contains the dates of manufacture, the quantity manufactured, the quantity released for distribution, control numbers used and the acceptance records which demonstrate the device is manufactured in accordance with the DMR. See 21 CFR 820.184.

A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for the lack of: A. Establishment registration by the foreign manufacturer B. Medical device listing by the foreign manufacturer C. Substantially equivalent letter from FDA D. Establishment registration by the initial distributor

A. Establishment registration by the foreign manufacturer The initial importers must register, but not all foreign manufacturers are required to register only if sold in the US

Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act before marketing a device: A. Makes the product misbranded under Section 502 of the Act B. Introduces an unapproved product into interstate commerce C. Causes the product to be mislabeled D. None of the above

A. Makes the product misbranded under Section 502 of the Act The product is considered to be misbranded if the product is not cleared through the 510(k) process. See the federal FD&C Act, Section 502(o). Note: A product is considered adulterated if the product requires an approved PMA but does not have one.

A device company allows its sales force to maintain a product inventory in the field. The device has an expiry date on its labeling. A sales person notes one of his products has expired and contacts headquarters office. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall? A. Not a recall-it is considered normal stock rotation B. Class I recall C. Class II recall D. Class III recall

A. Not a recall-it is considered normal stock rotation This action will be considered as market withdrawal; involves no violation of the act. It is considered normal stock rotation. Regulatory Reference: 21 CFR 806

The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT: A. Prepare criteria for the MDR report B. Prepare a brief statement of reasons for noncompliance with regulation C. Identify all omissions in PMA content D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation

A. Prepare criteria for the MDR report MDR reporting is a post PMA approval requirement.

The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report

A. Report incidents in which a device may have caused or contributed to a death or serious injury Initial importers are subject to Medical Device Reporting (MDR) under 21 CFR 803.40.

A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. De novo 510(k)

A. Special 510(k) A Special 510(k) is allowed if a modification to the legally marketed device is being made that relies on compliance with design controls, including design validation. The incentive provided for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30 days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA for review? A. Submit a Device Master File (MAF) B. File its own PMA C. Supply the applicable sections of the finished device manufacturer's PMA directly to FDA D. Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements

A. Submit a Device Master File (MAF) - A pre-market approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information. - Often the applicant needs to use another party's product (e.g., ingredient, subassembly, or accessory) or facility in the manufacture of the device. In order that a sound scientific evaluation may be made of the PMA, IDE, or other device submission, the review of data and other information related to the other party's product, facility, or manufacturing procedures is required. - The other party, while willing to allow FDA's confidential review of this information, may not want the IDE, premarket notification [510(k)], or PMA applicant to have direct access to the information. - To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system. - In addition, a master file may be considered when several applications may be submitted for different products which may use a common material or process, etc., such as the same sterilization method.

Which of the following is NOT true with respect to IDEs for significant risk products? A. The investigational product must be mfged in full compliance with CGMP B. Clinical studies must be reviewed and approved by an IRB C. The IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include and environmental impact statement that contains a claim for categorical exclusion or and environmental assessment

A. The investigational product must be mfged in full compliance with CGMP Devices under approved IDEs are exempt from CGMP regulations except for design control requirements; investigational new drugs must be compliant with CGMP for finished pharmaceuticals. Regulatory Reference: 21 CFR 211.

A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed? A. This requires a new 510(k) since significant change in product instructions might affect efficacy. B. After submission in a periodic report C. After reporting clinical studies in an annual report D. After submission of labeling change

A. This requires a new 510(k) since significant change in product instructions might affect efficacy. A new intended use requires a 510(k) clearance.

A device mfger is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is mfger preparing to submit to FDA? A) A PMA B) A Special 510k C) An Abbreviated 510k D) An Annual Report for a PMA

B) A Special 510k

510(k)s 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 IVDs are regulated by CBER.

The QSR for devices regarding Design Controls require: 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 only required for Class III Investigational devices

B) Design and development plans address how design inputs and requirements are managed

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 Distributors are not required to report to FDA

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

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 Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. - Eyeglass frames, 886.5842 - Lenses, spectacle, 886.5844 -Sunglasses, non-prescription, 886.5850

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. PMA

B. Abbreviated 510(k)

What is the formal early collaboration meeting that was implemented throught the Food and Drug Modernization Act (FDAMA)? A. PDP Meeting B. Agreement Meeting C. Pre-IDE Meeting D. Pre-PMA Meeting

B. Agreement Meeting The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be held within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).

The QSR calls for finished device mfgers to carry out all of the following EXCEPT: A. Quality audits conducted by individuals who don't have direct responsibility for operation being audited B. Annual audits of operations C. Document the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited

B. Annual audits of operations Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures that these procedures are implemented effectively and that procedures are suitable to achieve quality system objectives.

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital for reversible medical consequences as a result of the defective product. What type of recall classification would be assigned to this product. A. Class I B. Class II C. Class III D. Class IV

B. Class II Exposure to this product may cause temporary or medically reversible adverse health consequences. Regulatory Reference: 21 CFR 7.3; 21 CFR 7.41

Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have: A. Expert GMP knowledge B. Clear and precise specifications from the manufacturer C. Detailed knowledge of the manufacturer's operations D. An internal audit program

B. Clear and precise specifications from the manufacturer An agreement outlining the manufacturer's specifications would minimize quality deficiencies. 21 CFR 820.81(b).

All Class I devices are subject to following EXCEPT: A. Device Master File (DMF) B. Design History File (DHF) C. Device History Record (DHR) D. Medical Device Reporting (MDR)

B. Design History File (DHF) Most Class I devices are not subject to design controls under 21 CFR 820.30 and therefore Design History Files are not required.

Company X is developing marketing materials for Class II device known as "Y". In one marketing piece, company talks about clinical data supporting marketing of the device. Which of the following statements is illegal and should NOT be included in marketing materials? A. Company X has conducted clinical studies to demonstrate S&E of device Y B. Device Y is approved for marketing in the US C. Warning: Device Y is not compatible with MRI equipment D. Caution: Device Y, when improperly deployed, can cause bleeding

B. Device Y is approved for marketing in the US Class II devices are cleared for marketing in the US by the FDA, not approved. Regulatory Reference: 21 CFR 807.97.

Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE? A. Investigator shall report withdrawal of approval by the IRB to sponsor within 5 working days. B. Investigator shall report device use without informed consent to sponsor and IRB within 10 working days after use occurs. C. The sponsor shall notify FDA within 30 working days of the completion or termination of an investigation for a sig risk device. D. An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect within 10 working days after the investigator first learns of the effect.

B. Investigator shall report device use without informed consent to sponsor and IRB within 10 working days after use occurs. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 5 working days after the use occurs. See 21 CFR 812.150(a)(5).

A US device contract mfger has customers for whom it mfgs device components (parts) and finished devices. To date, all products have been either parts for Class II devices or Class II finished devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should as in order to begin assessing the impact of Class III on plant operations? A. Is it a sterile device? B. Is it a component or device that would be mfged? C. Is it an implantable device? D. Is it a single use device?

B. Is it a component or device that would be mfged? The cited QSR reference states that this regulation is not applicable to component (part) manufacturing; so knowing that it is a component may eliminate QSR compliance. To assess the regulatory impact, one must first know what is to be manufactured at the site, i.e., component or finished device. Many contract device component manufacturers do comply with the QSR; however, in this case, knowing that the new business for a Class III device was to manufacture a component only, would help determine the applicable regulations. For instance, if the job was to manufacture a component only, the need for sterilization may be eliminated because the manufacturer of the finished device may sterilize the component once configured in the finished device. If it were ascertained that the new business was to produce the finished product, the QSR would apply, and possibly other requirements such as 21CFR Part 821 Medical Device Tracking as well. Regulatory Reference: 21CFR 820.1 (a) the Quality System Regulation (QSR).

MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following are true EXCEPT: A. The establishment must market at least one device in the US and must market a device "in one or more foreign countries." B. Manufacturers of class III devices are not eligible for 3rd party inspections. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are required to notify FDA of the person it intends to use and FDA must agree to the selection.

B. Manufacturers of class III devices are not eligible for 3rd party inspections. MDUFMA amends section 704 of the FD&C Act to authorize FDA accredited individuals to inspect qualified manufacturers of class II and class III medical devices.

Premarket Notification is required of manufacturers when introducing: A. New label size B. New Class II devices C. A change in product name D. Additional manufacturing sites

B. New Class II devices

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT: A. Establishment registration B. Premarket approval application C. Medical device reporting D. Listing of the device

B. Premarket approval application Premarket approval application (PMA) is not a general control.

Which is considered part of the Device Master Record? A. Employee training record B. Serial number label C. Design reviews D. Calibration records

B. Serial number label Labeling specifications are part of the DMR. Regulatory Reference: 21 CFR 820.181(d).

Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System? A. Production and process controls B. Test and control article characterization C. Packaging and labeling controls D. Facility and equipment controls

B. Test and control article characterization

While seeking a new Class III indication for a device currently on the market as Class II, a company received a vote of "non-approvable" from an FDA Advisory Panel. Possible course of action include all of the following EXCEPT: A. Continue marketing device for its Class II indication B. Update current labeling to include new indication C. Proceed with a PMA submission to FDA D. Request face-to-face post-panel meeting with FDA

B. Update current labeling to include new indication Regulatory Reference: 21 CR 807.90-3; 21 CFR 801.4

A new Class II device with electrical components was subjected to extensive standard testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device? A Traditional 510k B Special 510k C Abbreviated 510k D PMA

C Abbreviated 510k A manufacturer has the option to submit an Abbreviated 510(k) when FDA has recognized relevant consensus standards that are applicable to the device. This Abbreviated 510(k) will include a declaration of conformity to the recognized consensus standards, and this declaration, in many cases, should eliminate the need to review actual test data for those aspects of the device addressed by the standards, thus the review will be more efficient. Regulatory Reference: FD&C Act Section 514 ; The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications—Final Guidance ; Guidance for Industry and FDA Staff: Recognition and Use of Consensus Standards ; FDA Standards Database Search (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm) ; 21 CFR Part 814.

In a device company, who has ultimate responsibility for data integrity and product quality : A Quality Assurance B Quality Control C Management D Regulatory Compliance

C Management Management has the ultimate responsibility to ensure that the quality systems are effective and a quality policy is implemented and followed as intended, which assures the integrity of the data and quality of the product. Regulatory Reference: 21 CFR 820.20(a).

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 Part 812 - Only covering setting up Clinical Trial - Requirements for what happens during a trial will be covered later. Part 50 - Mention Foreign Studies here. These regulations apply only to studies conducted in the USA. FDA will accept foreign data for marketing submissions. March 2001 guidance reaffirmed for devices FDA will accept data provided 1983 version of Declaration of Helsinki or the laws/regulations of the country the study is being conducted in are followed (whichever is stricter). Foreign data - similar protocol, applicable populations, etc. Part 54 - published Feb. 2, 1998. Submit information in marketing application Purpose to identify and disclose financial interests/agreements of clinical investigators that may affect the integrity of the data Part 56 - Purpose of IRB is to protect the rights and welfare of human subjects

An important distinction of a Humanitarian Use Device (HUD) according to the Humanitarian Device Exemption (HDE) is that: A) The HDE application must contain the same i, B) An HDE application is not required to conta C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose. D) An HDE application must be within 30 days a

C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose. Regulatory Reference: 21 CFR Part 814 (Subpart H)

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.

The QSR for devices (21 CFR 820) pertains to 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

The QSR for devices (21 CFR 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 Remember, I said that the QSR is written in a "generic" voice where what you are expected to do is stated but HOW you accomplish the requirement is not detailed.

When should manufacturer of a Class III device expect to have an FDA premarket approval inspection? A) Following submission of an IDE application B) After Phase II of the IDE study C) Prior to approval of the PMA D) Within 2 years of PMA approval

C) Prior to approval of the PMA Regulatory Reference: 21 CFR 807

Design Control "verification" requires which of the following: A) Product design meets user needs B) Process produces product that meets predetermined specs C) Product design meets specified requirements D) Product design meets intended use requirements

C) Product design meets specified requirements

Which PMA supplements are NOT subject to user fee exemption? A) Special PMA Supplements/CBE B) PMA Manufacturing Site Change Supplements C) Real Time Supplement D) 30 Day Notices, 135 Day Supplements

C) Real Time Supplement

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days B. 15 calendar days C. 30 calendar days D. The next quarterly or annual report

C. 30 calendar days Serious injury must be reported within 30 days even if it is expected and stated in the IFU

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976, it can use which regulatory paths: A. IDE B. PMA C. 510(k) D. Special Assessment Protocol

C. 510(k) 510(k). Regulatory Reference: 21 CFR 807, Subpart E

A manufacturer which of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time B. A device intended solely for veterinary use C. A custom device being studied for safety and effectiveness in support of commercial marketing D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time and intended solely for veterinary use

C. A custom device being studied for safety and effectiveness in support of commercial marketing While a custom device may be studied in humans without an IDE, if its safety and efficacy are being studied in support of commercial marketing, an IDE must be filed; see 21 CFR 812.2(c)(7).

Under IDE regulation, all must be reported to sponsor within five working days EXCEPT: A. Deviation from investigational plan B. Withdrawal of IRB approval C. Unanticipated adverse device effect D. Use of a device without informed consent

C. An unanticipated adverse device effect Regulations An investigator shall notify the sponsor and IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs. Withdrawal of IRB Approval A sponsor shall notify FDA and all reviewing IRB's /investigators of any withdrawal of IRB approval within 5 working days after receipt of the withdrawal of approval. An investigator shall report to the sponsor, within 5 working days, a withdrawal of IRB approval An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect occurring as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP

C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case.

Per the QSR, when an investigation of a complaint is conducted, all of the following are requirements for inclusion in investigation record EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant

C. Changes in procedures correcting quality problems The requirement is for corrective and preventative action and only needed if corrective action was taken per investigation. See Sec. 820.198. Complaint files.

A humanitarian device exemption (HDE) differs from a traditional PMA in that: A. It does not require compliance with QSR. B. Non-clinical data are not required. C. Effectiveness data are not required. D. Device characteristics are not required.

C. Effectiveness data are not required.

During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical investigation without obtaining informed consent from the subject. Which of the following should the regulatory affairs professional do? A. Predate the informed consent with a memo to the site file B. Contact the patient to obtain the informed consent immediately C. Ensure that the study director for the sponsor discusses the issue with the investigator D. Report the protocol deviation to the IRB

C. Ensure that the study director for the sponsor discusses the issue with the investigator Per 812.150(a)(5) and (b)(8)

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 After the departure of therapeutic biological products to CDER, CBER was left with the rest which essentially amounts to blood and related products, vaccines and gene therapy, some devices and diagnostic test kits. In the test question, I tried to distract you by putting blood into several of the responses because when I hear blood, I think CBER. The key words are HIV (read blood related) and diagnostic test kit Thus, C is the best answer A) Incorrect - regulated by CDRH B) Incorrect - regulated by CDRH C) Correct - in vitro diagnostic D) Incorrect - regulated by CDRH

According to the Quality System Regulation, suitable maintenance of equipment is necessary to ensure that manufacturing specifications are met. All of the following are requirements for the equipment EXCEPT: A. A written maintenance schedule is required B. Allowable tolerances are posted on or near the equipment C. Maintenance must be performed at least annually D. Inspections of equipment must be documented

C. Maintenance must be performed at least annually QSR does not specify "annually": Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as: A. Product recall B. Stock recovery C. Market withdrawal D. Corrective action

C. Market withdrawal

Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be: A. Adulteration. B. Improper use C. Misbranded D. Fraudulent

C. Misbranded A marketed device that needs a 510(k) for commercialization but failed to comply with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).

Devices that are exempt from premarket notification are: A. All Class I devices B. Some Class I devices C. Most Class I devices and some Class II devices D. All Class I devices and some Class II devices

C. Most Class I devices and some Class II devices Regulatory Reference: 21 CFR Parts 862 -- 892

A new device undergoes design review. The review determines current analytical data do not provide enough info to move ahead with human testing. A decision is made to discard the data and begin a new study with the same protocol. This is an acceptable approach if: A. Intended use of the product does not change B. Original data are destroyed before new testing starts C. Original data are stored in device design history file D. New study tests three times as many samples as the old one.

C. Original data are stored in device design history file 21 CFR 820.30 (e) Design review - Each manufacturer shall establish...that formal documented reviews...are planned and conducted. ...the results of the design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file. 820.30(f)...The results of the design verification, including identification of the design, method(s), the data, and the individual(s) performing the verification, shall be documented in the DHF. Regulatory Reference: 21 CFR 820.30 Design Controls; 820.30(f) DHF.

Procedures for identifying the control number for each unit, lot or batch of finished devices is required for which type of medical device? A. Surgical gloves B. X-ray machines C. Pacemakers D. Syringes

C. Pacemakers According to 21 CFR 820.65, "Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components." The Pacemaker is a Class III implantable device and is subject to 21 CFR 820.65. Regulatory Reference: 21 CFR 820.65 Traceability

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Comparator device B. Predecessor device C. Predicate device D. Substantially equivalent device

C. Predicate device An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process; 21 CFR 807.100(b). The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.

The Medical Device User Fee and Modernization Act of 2002 enacted all the following except: A. User fees for premarket reviews B. Office of Combination Products C. Prescription Drug User Fee Act (PDUFA) renewal for five additional years

C. Prescription Drug User Fee Act (PDUFA) renewal for five additional years

You are a German-based device manufacturer whose device is packaged in Ireland and sold in the US through a US-based company. The 510(k) was writtten by a contract organization. The label of our product may indicated any of the following EXCEPT" A. The principle place of business in the US B. The packaging location address C. The address of the contractor who submitted the 510(k) D. The address of the distributor

C. The address of the contractor who submitted the 510(k) Regulatory Reference: FDCA 801(e)(i). Medical devices; name and place of business of manufacturer, packer or distributor. (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer or distributor.

A handling and storage system for medical devices must always include: A. Procedures for rotation of stock B. Separate rooms or cages for release and quarantine products C. Procedures for product receipt and transfer D. Environmentally controlled areas for products with shelf life

C. Procedures for product receipt and transfer Procedures for receipt and transfer of products are required; see 21 CFR 820.150(b).

While reviewing complaint files for a drug-eluting stent, a single entity combination product, it was noticed that an adverse event had occurred and a patient was hospitalized for two additional days. Such an adverse event was a foreseeable event and the mechanical features of the stent contributed to the occurrence. As a regulatory professional, your decision regarding the adverse event report would be: A. Report to FDA in a 15 Day Alert Report B. No action is needed as ADE reporting is only required for serious and unexpected adverse events; this ADE is expected so no reporting is needed C. Report to FDA in Form 3500A (MDR) within 30 days D. Report to FDA within 7 calendar days

C. Report to FDA in Form 3500A (MDR) within 30 days Under FD&C Act Section 503(g) (1), assignment to a lead center is based upon the combination product's primary mode of action (PMOA). In this product the device has the PMOA. As a device it follows the MDR reporting requirements. 21 CFR 600.80, 21 CFR 803.20(c), 21 CFR 312.53 1 and 2 are postmarket reporting requirements for drugs. 4 is a reporting requirement for an IND.

When FDA declares a device from a 510(k) application to be NSE and requires a PMA, what is the first option for a company? A. File a PMA immediately B. Petition CDRH to down-classify the device (de novo process) C. Resubmit a 510(k) with new data to demonstrate device is at least as safe and effective as predicate D. Submit this product for approval in Europe

C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate. Although an NSE Letter places the devices into the PMA category, FDA allows a company to refile the 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate. Petition to down-classify the device is the option when there are no comparable predicate devices but the "most practical" option is to refile the 510(k). The other goal of this question is to inform the examinee that although an NSE Letter places the device into the PMA category, it does not mean FDA is asking for a PMA filing. Regulatory Reference: 21 CFR 807.100; FDA CDRH Learn Presentation: 510(k) Overview

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control (QC). Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through: A. A postapproval study report B. A medical device report C. This information does not need to be submitted D. An Annual Report

C. This information does not need to be submitted Regulatory Reference: 510(k) Memorandum #K97-1 Deciding When to Submit a 510(k) for a change to an existing device. Changes that require review for 510(k) notification include: o Technology/performance changes o Operating principle changes o Material changes o Labeling changes * This scenario does not meet any of these criteria

The manufacturer of an approved prostate-specific antigen (PSA) test developed a new automated analyzer to perform the total PSA testing. There was no change to the test's indications for use or technology and no new clinical data were required. Only analytical testing was performed to demonstrate that the new analyzer did not alter the performance of the assay. What kind of PMA supplement to the approved PMA will be required for this change? A. Special PMA Supplements Changes Being Affected B. 30 day Notice C. Real Time Supplement D. 180-Day Supplement

D 180-Day Supplement

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

At completion of 510(k) review, FDA may take the following actions except: A) Declare device SE B) Declare device not SE C) State a 510(k) is not required to market the device D) Approve the device for market

D) Approve the device for market 510(k) is for clearance to market not an approval

According to QSR, personnel involved in design, mfg, distribution, servicing, and reporting must: A) Must hold a Master's degree or higher B) At a minimum receive procedure training annually in their area 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

Which of the following is NOT a key medical device submission which directly leads to marketing permission from FDA? A) 510(k) B) HDE C) PMA D) IDE

D) IDE, Investigational Device Exemptions, Part 812 Your IDE is a permission to ship product for clinical trial use only. It is the mechanism to have an EXEMPTION to meeting the pre-market notification or pre-market approval requirements, in order to perform your clinical trials. IDE are a part of the process for product registrations that require clinical trial data, but the IDE does not directly lead to marketing permission.

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)

With respect to a Non-Significant Risk device clinical trial, which 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 trial protocol to FDA for approval

D) Submission of trial protocol to FDA for approval FDA approval not needed for NSR (Non-Significant Risk device)

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

Which of the following sections is required in a PMA? A. Patent certification information B. A copy of quality manual C. An economic cost/benefit assessment D. A discussion of benefit and risk considerations

D. A discussion of benefit and risk considerations See 21 CFR 814.20(b)(3)(vi).

A company intends to add an indication to a 510(k) device currently being marketed but not distributed. Which submission is appropriate? A. A PMA B. An Investigation Device Exemption C. A Special 510(k) D. A traditional or abbreviated 510(k)

D. A traditional or abbreviated 510(k) A Traditional 510(k) is required for changes involving indications for use. Regulatory Reference: FDA Guidance on When to Submit a New 510(k) for a Device Change.

A company begins to market pacemaker (Class III) the same day regulatory professional mails PMA to FDA. The pacemaker is considered: A. Legally marketed B. Misbranded C. Investigational D. Adulterated

D. Adulterated Class III medical device is adulterated if it doesn't have an approved PMA and is not otherwise exempt. A legally marketed device in the US has been cleared, approved or exempted from review by the Food and Drug Administration. Regulatory Reference: 21 CFR Part 814.

An IVD submission could be submitted as a(n): A. NDA B. BLA C. 510(k) D. BLA or 510(k)

D. BLA or 510(k) IVDs can be submitted as a 510(k) under the Food, Drug, and Cosmetic Act or a BLA under the Public Health Service Act. Regulatory Reference: Public Health Service Act, Food, Drug, and Cosmetic Act.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: A. Class I and II devices B. Class I devices only C. Class II devices only D. Class II and III device

D. Class II and III device Class I devices are the least hazardous and are not the primary focus of FDA inspections. Third party inspections allow FDA to focus on higher-risk inspections.

Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers

D. Component manufacturers Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

Which mfgers must register their mfging facility with FDA? A. Component mfgers who sell only to device mfger using their components B. Domestic (US) contract mfgers who do not directly distribute the final product to the market C. Domestic mfger of device being investigated under an IDE D. Foreign mfgers shipping devices into US for sale in US

D. Foreign mfgers shipping devices into the US for sale in the US All foreign mfgers making devices distributed in the US must register with FDA.

Under IND/IDE regulations, obligations of a clinical study investigator do NOT include: A. Providing a final study report to the IRB B. Protecting the rights, safety and welfare of study subjects C. Controlling the test materials under investigation during the study D. Keeping all unused test material at their facility until the drug/device is approved by FDA

D. Keeping all unused test material at their facility until the drug/device is approved by FDA

You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new listing for the device? A. You have added new sizes and shapes in the product portfolio. B. You have changed the material composition of the device. C. You have changed the package of the device. D. None of the above.

D. None of the above. According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device or device class listed with the FDA. Devices having variations in physical characteristics such as size, package, shape, color or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device.

Under QSR, device design requirements MUST meet needs of: A. Manufacturer B. Patient C. User D. Patient and user

D. Patient and user QSR requires design input as defined in 21 CFR 820. 30 (c) meet the needs of both the patient and user.

The following are required per QSR EXCEPT: A. Device History Record (DHR) B. Device Master Record (DMR) C. Design History File (DHF) D. Quality Manual (QM)

D. Quality Manual (QM) DHR is required per 21 CFR 820.184. DMR is required per 21 CFR 820.181. DHF is required per 21 CFR 820.30. Quality Manual is a requirement of ISO13485:2003. It is not required by QSR, although such a manual would be helpful in explaining the nature and extent of the QMS to an FDA investigator during an inspection. Regulatory Reference: 21 CFR Part 820 and ISO 13485.

The QSR includes requirements for Design Controls. All of the following statements about Design Reviews are true EXCEPT: A. Mfgers required to maintain procedures to ensure formal reviews occur at appropriate stages of design and dev B. Participation at design reviews must include reps of all fxns concerned with the stage being reviewed. C. Participation shall include at least one individual who does not have direct responsibility for stage being reviewed. D. Results of design review shall be documented in the device history record.

D. Results of design review shall be documented in the device history record. The results of the design review shall be documented in the device history file (DHF); see 21 CFR 820.30(e).

When a manufacturer is performing design validation activities, which element is NOT included as a requirement under device design validation section of the QSR? A. Conformance to defined user needs and intended uses B. Testing of production units under actual or simulated use conditions C. Software validation D. Translation of device design into production specifications

D. Translation of device design into production specifications Translation of device design into production specifications is covered under 820.30(h) Design transfer.

According to the QSR, Design Outputs contain the following: A) Device Master Record (DMR) B) The documentation from the last phase of the complete Design Control process C) Test reports that support the Design Inputs met D) All packaging and labeling associated with finished device E) A and D above

E) A and D above NOT RAC TEST STYLE QUESTION

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 NOT a RAC test style question Pre-clinical refers to any testing NOT performed in a human being.

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