•  11/4/2020 04:46 AM

There are three types of studies described in the regulations at 21 CFR Part 812: significant risk (SR) device studies, non-significant risk (NSR) device studies, and exempt studies

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  •  11/4/2020 04:35 AM

In accordance with section 520(g) and the regulations, clinical studies of medical devices must comply with FDA’s human subject protection requirements (informed consent and additional safeguards for children in research) (21 CFR Part 50), Institutional Review Board (IRB) requirements

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  •  11/4/2020 04:16 AM

The act and the HDE regulations do not require informed consent. Because an HDE provides for marketing approval, use of the HUD does not constitute research or an investigation which would normally require consent from the study subjects.

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  •  11/4/2020 04:08 AM

Initial review: Initial IRB approval should be performed at a convened IRB meeting. The IRB does not need to review and approve individual uses of an HUD, but rather the IRB may approve use of the device as it sees fit.

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  •  11/4/2020 04:02 AM

An HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year

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  •  11/4/2020 04:00 AM

A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.

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  •  11/3/2020 07:38 AM

A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to market a medical device. If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required,

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  •  11/3/2020 06:19 AM

Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. A longer list of examples of medical devices is in the FDA Information Sheet Guidance, “Significant Risk vs. Non-Significant Risk Devices.”

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  •  11/3/2020 06:06 AM

In accordance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices into one of three regulatory classes based on the level of control necessary to ensure safety and effectiveness of the device

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  •  11/3/2020 05:48 AM

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory

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