RegulatoryGlossary Term
An FDA approval that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval application or 510(k) submission.
The Investigational Device Exemption permits clinical investigation of medical devices that are not yet approved or cleared for commercial distribution in the United States. Analogous to the IND for drugs, the IDE provides regulatory oversight of device studies while enabling the collection of clinical data necessary for marketing applications. The IDE requirements ensure that clinical investigations are conducted safely, with appropriate informed consent and IRB oversight, while not imposing the full regulatory requirements applicable to marketed devices.
IDE requirements vary based on the risk classification of the device and the nature of the study. Significant risk device studies, involving devices that present potential for serious harm, require FDA approval of an IDE application before the study can begin. The application must describe the device, the proposed clinical protocol, manufacturing information, investigator qualifications, and risk analysis. Nonsignificant risk device studies may proceed after IRB approval without formal IDE submission to FDA, though they must still comply with IDE regulations regarding informed consent, labeling, and record-keeping.
The distinction between significant and nonsignificant risk is based on an assessment of the device's potential to cause harm. Significant risk devices include those that are implants, life-supporting or life-sustaining, or otherwise present unreasonable risk of illness or injury. For studies requiring IDE approval, the FDA review evaluates whether the investigation presents unreasonable risks, whether the research design is adequate to meet the study objectives, and whether adequate protections are in place for human subjects. IDE approval permits initiation of the clinical study, with ongoing requirements for safety reporting and progress updates.
Significant risk study
"The pivotal trial for the implantable cardiac device required an approved IDE, with the application demonstrating device safety through bench testing and prior feasibility studies, and proposing a controlled trial comparing the device to standard surgical treatment."
Nonsignificant risk determination
"The IRB determined that the study of the new diagnostic software presented nonsignificant risk, allowing the investigation to proceed with abbreviated IDE requirements without FDA submission."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
An FDA approval that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval application or 510(k) submission.
The Investigational Device Exemption permits clinical investigation of medical devices that are not yet approved or cleared for commercial distribution in the United States. Analogous to the IND for drugs, the IDE provides regulatory oversight of device studies while enabling the collection of clinical data necessary for marketing applications. The IDE requirements ensure that clinical investigations are conducted safely, with appropriate informed consent and IRB oversight, while not imposing the full regulatory requirements applicable to marketed devices.
IDE requirements vary based on the risk classification of the device and the nature of the study. Significant risk device studies, involving devices that present potential for serious harm, require FDA approval of an IDE application before the study can begin. The application must describe the device, the proposed clinical protocol, manufacturing information, investigator qualifications, and risk analysis. Nonsignificant risk device studies may proceed after IRB approval without formal IDE submission to FDA, though they must still comply with IDE regulations regarding informed consent, labeling, and record-keeping.
The distinction between significant and nonsignificant risk is based on an assessment of the device's potential to cause harm. Significant risk devices include those that are implants, life-supporting or life-sustaining, or otherwise present unreasonable risk of illness or injury. For studies requiring IDE approval, the FDA review evaluates whether the investigation presents unreasonable risks, whether the research design is adequate to meet the study objectives, and whether adequate protections are in place for human subjects. IDE approval permits initiation of the clinical study, with ongoing requirements for safety reporting and progress updates.
Significant risk study
"The pivotal trial for the implantable cardiac device required an approved IDE, with the application demonstrating device safety through bench testing and prior feasibility studies, and proposing a controlled trial comparing the device to standard surgical treatment."
Nonsignificant risk determination
"The IRB determined that the study of the new diagnostic software presented nonsignificant risk, allowing the investigation to proceed with abbreviated IDE requirements without FDA submission."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.