GCP of Devices with complete solutions

510(k) Clearance 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 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 FDA uses this term to refer to a clinical investigation designed to collect safety and effectiveness data HUD Use 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) 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) 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) 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) 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) 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). Significant Risk 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 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) 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 Submitting medical device reports to the HDE holder A clinician may use a HUD without IRB approval 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 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? 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 Investigational Device Exemption requirements An investigation to collect data on a new indication of a significant risk HUD requires IRB approval and an Investigational Device Exemption (IDE) Which of the following lists the three principles included in the Belmont Report? 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? 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? Information, comprehension, voluntariness Investigator an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team Device an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is: recognized in the official National Formulary, the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or other animals, or intended to affect the structure or any function of the body of humans or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and is not dependent upon being metabolized for the achievement of any of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 360j(o) of this title Medical Device dentified as any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related article:Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:Diagnosis, prevention, monitoring, treatment, or alleviation of disease;Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury;Investigation, replacement, modification, or support of the anatomy or of a physiological process;Supporting or sustaining life;Control of conception;Disinfection of medical devices; andWhich does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means (ISO 14155:2011) Sponsor The entity that takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. Note: the sponsor is often but not always the entity that funds the clinical research Sponsor-Investigator an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational device is being administered, used, or dispensed. The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator as outlined in the regulations Unanticipated Adverse Device Effect (UADE) any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects Significant Risk (SR) Device Device that poses a significant risk of harm to the health, welfare, or safety of the subject. These include devices that are implanted, devices that support or sustain human life, and devices that are very important in diagnosing, curing, mitigating, or treating disease or preventing impairment to human health (21 CFR 812.3). Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. Non-significant Risk (NSR) Device Device that does not pose a significant risk of harm to subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and temporary urinary catheters