FDA IDE - Investigational Device Exemption


An FDA IDE (investigational device exemption) permits an investigational device to be used in a clinical study in order to collect safety and effectiveness for a Premarket Approval (PMA) application. All evaluations of investigational devices, unless they are exempt, must have an FDE IDE before a study can commence.

It is difficult to obtain an FDA investigational device exemption if pre-clinical study data and other research and design material is not in order and under control. Medical device companies need to ensure that their processes and systems are effectively planned and effectively automated for best results.

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To Be Successful with FDA Investigational Device Exemptions

To be successful in any phase of the development and testing of a medical device, a company must have integrated solutions for CAPA, training, customer complaints, and nonconformances according to FDA IDE. An automated system for document control and document management (see information on MasterControl Documents) is equally important. This ensures the integrity of a company's documents and processes.

How MasterControl Helps with FDA IDE

MasterControl, a leading provider of software for regulated companies, offers configurable, easy-to-use integrated software applications. These solutions can help medical device manufacturers comply with the good clinical practices (GCP), and secure an FDA investigational device exemption (IDE). Automated solutions for document control (or document management), training, CAPA and nonconformances in addition to analytics software for analyzing clinical data, are critical to the success of a medical device company.

For More Information on FDA IDE

For more information about solutions that can help medical device companies obtain FDA IDEs at a faster rate, please feel free to contact a MasterControl representative.