GCP of Devices Exam Study Guide with Complete Solutions 510(k) Clearance - Correct Answer A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately.Humanitarian Device Exemption (HDE) Holder - Correct Answer The HDE Holder is the entity that obtains the approval of a HDE from the FDA and may be a manufacturer, sponsor, firm, or an individual.Humanitarian Use Device (HUD) Investigational Use - Correct Answer FDA uses this term to refer to a clinical investigation designed to collect safety and effectiveness data HUD Use - Correct Answer The FDA uses the term "use" to refer to the clinical use of a HUD according to its approved labeling and indications to treat or diagnose patients.Humanitarian Device Exemption (HDE) - Correct Answer an application that is similar to a premarket approval (PMA) application, but for which the manufacturer does not need to provide evidence of efficacy. HDEs are subject to restrictions on profitability and can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies.Humanitarian Use Device (HUD) - Correct Answer a device that is intended to benefit patients in the treatment or diagnosis of a disease or condition affecting not more than 8,000 individuals in the U.S. per year.Investigational Device Exemption (IDE) - Correct Answer refers to the regulations under 21 CFR 812 that apply to clinical investigations. An approved IDE means that the IRB (and FDA for significant risk [SR] devices) has approved the sponsor's study application as meeting the requirements under 21 CFR 812 (Investigational Device Exemptions
2014).
Nonsignificant Risk (NSR) - Correct Answer Device studies that involve a device that does not pose a significant risk to subjects. Examples of NSR devices include: most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and temporary urinary catheters.Premarket Approval (PMA) - Correct Answer any type of premarket approval application used to obtain FDA approval of certain types of medical devices. It is the most stringent application for medical devices. The FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s). 1 / 2
Significant Risk - Correct Answer Device studies that are those that involve a SR device. Examples of SR devices include: sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.The two-step process of obtaining an FDA marketing approval for a HUD includes - Correct Answer Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA Unless the IRB or privacy board waives the requirement, HIPAA requires the patient's authorization for the use and disclosure of protected health information (PHI) - Correct Answer If the use or disclosure of PHI is for the purpose of a clinical investigation with a HUD Clinicians using a HUD to treat or diagnose patients are responsible for - Correct Answer Submitting medical device reports to the HDE holder A clinician may use a HUD without IRB approval - Correct Answer If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient FDA approval of a Humanitarian Device Exemption (HDE) is based on all of the following criteria EXCEPT - Correct Answer Assurance of safety and effectiveness Which of the following statements is true regarding IRB approval of clinical use of a HUD in a healthcare facility? - Correct Answer The clinician obtains initial IRB approval and ensures continuing review approval by the IRB All of the following regulatory requirements apply to an investigation of a HUD consistent with the HDE approved indication(s), EXCEPT - Correct Answer Investigational Device Exemption requirements An investigation to collect data on a new indication of a significant risk HUD requires - Correct Answer IRB approval and an Investigational Device Exemption (IDE) Which of the following lists the three principles included in the Belmont Report? - Correct Answer Respect for persons, beneficence, justice Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Correct Answer Determining that the study has maximized potential benefits and minimized potential risks of harm to subjects Which of the following best describes the three elements of informed consent according to the Belmont Report's principles? - Correct Answer Information, comprehension, voluntariness
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