Term
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Definition
| Also known as a premarket notification [(510(k)] submission, it 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. |
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Term
| Humanitarian Device Exemption (HDE) Holder |
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Definition
| The entity that obtains the approval of a HDE from the FDA and may be a manufacturer, sponsor, firm, or an individual. |
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Term
| Humanitarian Use Device (HUD) investigational use |
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Definition
| FDA uses this term to refer to a clinical investigation designed to collect safety and effectiveness data. |
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Term
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Definition
| 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. |
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Term
| Humanitarian Device Exemption (HDE) |
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Definition
| 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. |
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Term
| Humanitarian Use Device (HUD) |
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Definition
| A device that is intended to benefit patients in the treatment or diagnosis of a disease or condition affecting fewer than 4,000 individuals in the U.S. per year. |
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Term
| Investigational Device Exemption (IDE) |
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Definition
| 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). |
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Term
| Nonsignificant Risk (NSR) |
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Definition
| Device studies are those 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. |
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Term
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Definition
| Any type of 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). |
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Term
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Definition
| Device studies are those that involve a SR device. Examples of SR devices include: sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. |
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