Exam 2 Results

FDA regulations governing medical device clinical investigations in the U.S. include which of the following? 21 CFR 812 21 CFR 314 21 CFR 312 21 CFR 600

21 CFR 812

You are a product manager at a medical device company in charge of ensuring the company's newest medical device follows the most appropriate regulatory pathway to approval. The device is classified as a significant risk Class III device. No predicate device exists. Which of the following are required in order to remain in compliance with federal regulations? 1 -- IND prior to starting clinical research 2 -- NDA to obtain marketing approval 3 -- IRB review and approval throughout a study 4 -- Compliance with IDE regulations in order to submit PMA 5 -- FDA approval of 510(k) prior to starting clinical research

3 & 4 only

You are a regulatory affairs officer at a medical device company. The company's newest creation is a combination drug/device product. Your company will try to provide substantial equivalence to an existing product. Which of the following describes the regulatory pathway to market approval associated with this strategy? Investigational New Drug application Investigational Device Exemption 510(k) Pre-Market Approval

501(k)

Which of these applications and/or wearables would not be regulated by FDA? A phone application that remotely alters the settings of an infusion pump A wearable wrist band and phone application that measures the number of steps walked as part of a healthy lifestyle An application that uses the phone's speakers to produce controlled levels of tones to assist in diagnosing possible otologic disorders An application that plays soothing sounds on a phone's speakers to help treat generalized anxiety disorder and panic attacks

A wearable wrist band and phone application that measures the number of steps walked as part of a healthy lifestyle

How often should the Investigator's Brochure be reviewed? At least twice a year At least once during the study At least annually At least every two years

At least annually

Which of the following is considered an emerging pharmaceutical market? Germany China France Japan

China

What is the classification of contact lens solutions? Class 3 only Contact lens solutions do not have a device classification Class 1 and Class 2 Class 2 and Class 3

Class 2 and Class 3

Which of the following device classifications identifies devices where safety and efficacy cannot be ensured by performance standards alone? Class 4 Class 3 Class 1 Class 2

Class 3

Which of the following device classifications is the most hazardous? Class 4 Class 3 Class 2 Class 1

Class 3

You are working at a medical device sponsor as a regulatory affairs manager. Your job is to ensure the company's newest product (Device Z) follows the most appropriate regulatory pathway to market approval by the FDA. The product development plan for Device Z requires an IDE to be filed. Which of the following most likely represents Device Z? Class I non-significant risk Class III non-significant risk Class II significant risk with a predicate device Class III significant risk

Class III significant risk

In the U.S., the development of new medical devices depends on which of the following? Investigational Device Exemption and FDA notification Risk of device and phase of research Class of device, phase of research, and existence of predicate device Class of device, risk of device, and existence of predicate device

Class of device, risk of device, and existence of predicate device

Device D contains new technology and is novel in treating the intended patient population. No predicate device exists and the device is classified as a Class 3 significant risk device. Which of the following regulatory pathways would be most appropriate for this medical device? Clinical research can be conducted via a 510(k) submission Clinical research must be conducted via an IND submission No clinical research needs to be conducted. Sponsor only needs to submit manufacturing information to FDA. Clinical research must be conducted via an IDE submission

Clinical research must be conducted via an IDE submission

Which of the following statements is correct about clinical research studies conducted in accordance with the U.S. Code of Federal Regulations? Compliance with U.S. federal regulations is only required for federally-funded clinical research studies. Compliance with U.S. federal regulations is more important than compliance with State laws. Compliance with U.S. federal regulations does not ensure compliance with ICH GCP. Compliance with U.S. federal regulations ensures compliance with ICH GCP.

Compliance with U.S. federal regulations does not ensure compliance with ICH GCP.

The Office of Combination Products: Decides if the device will be utilized in the adult or pediatric population Determines which FDA center will make a decision on the product's classification Determines whether the device is declared a transitional or a transient device Evaluates the ability of the device to effect its target population

Determines whether the device is declared a transitional or a transient device

Which of the following does not achieve its primary intended purpose through chemical action within or on the body of man or other animals and is not dependent on being metabolized for the achievement of its primary intended purpose? Drug Vaccine Device Biologic

Device

Which of the following is TRUE? Drug and device research involving human subjects must always be approved by an IRB Clinical research must be performed on all devices sold in the U.S. In the U.S., there are more FDA approved drugs than medical devices in circulation Combination products are always developed through rigorous Phase 1, Phase 2, and Phase 3 research

Drug and device research involving human subjects must always be approved by an IRB

You are a product manager developing a timeline for the upcoming clinical research study on an unapproved device. Who determines the classification of your unapproved device? Principal Investigator FDA Sponsor IRB

FDA

Which of the following medical devices would most likely be considered a Class 3 device? Gastric lap band implanted in patients for weight loss Magnetic resonance imaging (MRI) machine used to non-invasively visualize internal structures of the body Sterile surgical gloves Flu diagnostic kit using nasal mucosal samples taken from cotton swabs

Gastric lap band implanted in patients for weight loss

Which of the following regulatory pathways should a medical device that affects less than 4,000 patients a year in the U.S. take? Humanitarian Device 510(k) IND IDE to PMA

Humanitarian Device

Which of the following regulatory paths are available for the development of devices for rare conditions (affects or is manifested in fewer than 4,000 individuals in the United States per year), similar to the orphan drugs for devices? The Rare Disease Act Orphan Device Humanitarian Device Exemption Compassionate Use

Humanitarian Device Exemption

Device Q is classified as Class II, is considered "non-significant risk", and will be submitted to the FDA via the 510(k) process. What step would most likely be completed in order for Device Q to be approved through the 510(k) process? Submission of an IDE to the FDA and obtaining IRB approval from each investigative site Identification of a predicate device and establish substantial equivalence to the predicate device Evaluation by the Office of Combination Products and determination of FDA center jurisdiction Submission of an IND to the FDA

Identification of a predicate device and establish substantial equivalence to the predicate device

Due to many regulatory and safety concerns, which of the following emerging markets have seen a sharp decline in research growth? Turkey China Brazil India

India

Device A is classified as Class 3 but the determination risk has yet to be established. Who will determine risk for Device A? All answer choices are correct Institutional Review Board (IRB) FDA via IDE submission FDA via 510(k) submission

Institutional Review Board (IRB)

ICH is an abbreviation for: International Conference on Harmonisation International Committee on Harmonizing Research Intercontinental Committee of Health Internal Council for Healthy subjects

International Conference on Harmonisation

The main difference between drug and device development in the U.S. is: Investigational drug research requires informed consent for all regulated clinical trials Investigational device research does not require monitoring Investigational device research depends on a class-based and risk-based determination Investigational drug research investigators do not need to submit financial disclosure

Investigational device research depends on a class-based and risk-based determination

Which document must contain a brief description of the drug substance and formulation, a summary of pharmacological and toxicological effects of the drug, information regarding the pharmacokinetics and biological disposition of the drug, and pre-clinical safety information regarding the drug? Choose the BEST answer. Investigator's Brochure Investigational Product Packing Slip Informed Consent Protocol

Investigator's Brochure

Which phase of research is oftentimes conducted in a specialized clinic that includes 24 hour safety monitoring, on-staff nutritionists, and a crash cart with AED? Choose the BEST answer. Phase 1 Phase 2 Phase 4 Phase 3

Phase 1

Which phase of drug development is typically the most costly? Phase 2 Phase 1 Phase 3 Pre-Clinical

Phase 3

The Office of Combination Products at the FDA is responsible for assigning primary jurisdiction for a combination product. Which of the following characteristics primarily determines where jurisdiction is assigned? Primary mode of action Mode of action Approximate number of treatable patients available each year Therapeutic effect

Primary mode of action

Depression affects millions of patients every year in the U.S. and is a $17 billion market worldwide. You are part of a company developing a new product which combines an unapproved investigational anti-depressant medicine and a transdermal patch. The product is designed to conveniently deliver the investigational anti-depressant over the course of 30-days. The FDA determines the primary mode of action is therapy received from the anti-depressive medication. Which of the following regulatory pathways would most likely apply to this product? Regulator pathway for an Orphan drug Regulatory pathway for a Humanitarian Use Device Regulatory pathway for a drug Regulatory pathway for a device

Regulatory pathway for a drug

Why are devices classified by risk? Risk-based classification allows manufacturers to avoid regulatory scrutiny Risk-based classification allows for IRBs to protect subjects who are at greatest risk Risk-based research is easier to conduct Risk-based classification allows for FDA to apply more stringent control over higher risk products to ensure safety while minimizing regulatory burden on lower risk products to promote innovation

Risk-based classification allows for FDA to apply more stringent control over higher risk products to ensure safety while minimizing regulatory burden on lower risk products to promote innovation

Which of the following statements is false? ICH guidelines are generally more strict that U.S. federal regulations Each country has their own specific rules and regulations in regards to conducting clinical trials within their borders Sponsors can submit clinical trial data to the FDA if the trial was conducted in another country Sponsors cannot submit clinical trial data to the FDA if the trial was conducted in another country

Sponsors cannot submit clinical trial data to the FDA if the trial was conducted in another country

You are an FDA inspector. You are conducting an inspection in the U.S. at a clinical research site. The study you are currently focusing on is following ICH standards. Which of the following is TRUE? U.S. federal regulations prohibit an investigator from following ICH guidelines. U.S. federal regulations overrules ICH guidelines because U.S. federal regulations are always more strict ICH guidelines do not require IRB approval The Principal Investigator must follow ICH guidelines

The Principal Investigator must follow ICH guidelines

Why was the first manufacturing of the artificial heart (Jarvick-7 by Symbion, Inc.) shut down? The company violated FDA guidelines and regulations regarding manufacturing quality control The company declared bankruptcy The company could not show the IRB that the artificial heart had a good risk/benefit ratio The first artificial heart did not work

The company violated FDA guidelines and regulations regarding manufacturing quality control

According to the discussion in class, when conducting clinical research in Tibet, what cultural considerations should be made? Clinical research should not be conducted in Tibet Use an alternative route to talk about the possible risks of study participation Ensure all study forms, including the informed consent, are in English Before enrolling a female in research, seek a male relative's consent first

Use an alternative route to talk about the possible risks of study participation

Which of the following is an example of a class III device? Vertebral implant surgical gloves MRI diagnostic device Dental drill

Vertebral implant

When should breaking the blind of a study product be done? When the subject finishes their participation in the trial The blind should never be broken for any reason When knowledge of the treatment assignment is necessary for the subject's care When the subject requests to know their study treatment

When knowledge of the treatment assignment is necessary for the subject's care

You are a physician recently appointed to oversee all clinical research trials at a major metropolitan hospital. You hold a meeting with all the Principal Investigators. During the meeting, one of the PIs asks whether they should be complying with US Title 21 regulations or with ICH guidelines. Which of the following would BEST help you to determine the proper regulations to follow? You state all research in the U.S. must comply with applicable part of Title 21. Therefore you must always comply with Title 21 regardless of the research you are conducting. You state all research in the U.S. must at least comply with the applicable parts of Title 21. However, if the protocol states ICH guidelines must be followed, then ICH guidelines will need to be followed. You state all research must be submitted to the FDA for review and approval. The FDA will determine which regulations must be followed. You state it is up to the IRB to determine which regulations must be followed.

You state all research in the U.S. must at least comply with the applicable parts of Title 21. However, if the protocol states ICH guidelines must be followed, then ICH guidelines will need to be followed.

Which of the following is an example of a class I device? automatic defibrillator tongue depressor automatic defibrillator cardiac stent

tongue depressor