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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Houston, TX, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The US Food and Drug Administration (FDA) has granted EndoQuest Robotics, Inc., a privately-held pioneer in the development of flexible endoluminal robotic technologies, an Investigational Device Exemption (IDE) for its pivotal colorectal clinical study, Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM).
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
Building on this success, Signati™ Medical will initiate the De Novo submission process with the U.S. Food and Drug Administration (FDA). This regulatory pathway aims to achieve market clearance for the Separo™ Vessel Sealing System, bringing this innovative device one step closer to transforming clinical practice for men's health.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Investigational Device Exemption – allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data; Investigational New Drug – allows an investigational drug to be used in a clinical study in order to collect safety and effectiveness data
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved ...