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SWEDISH MATCH ABSCTESTProtocol Number: SM 0801 STUDY ID Advance Study Number: 7694105INVNAM Investigator: Site: Subject Number: SUBJ ID Subject Initials: SCORES. . .RDC CASE REPORT FORM CONTROLLED

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How to fill out investigational device exemption ideide

01

To fill out an investigational device exemption (IDE) application, follow these steps:

02

Gather all necessary documentation and data to support your IDE application, such as clinical and non-clinical data, risk assessments, study protocols, and monitoring plans.

03

Complete the Form FDA 3674: IDE Application Cover Sheet, providing all required information and ensuring accuracy.

04

Prepare the Investigational Plan (IP) as per FDA requirements, including details about the device, study objectives, study design, patient population, data collection methods, and statistical analysis plan.

05

Include all relevant scientific and medical literature that supports the safety and effectiveness of the investigational device.

06

Provide a comprehensive explanation of the device's manufacturing process and quality control.

07

Develop a labeling and patient information package that includes instructions for use, warnings, precautions, and potential risks.

08

Submit the IDE application to the FDA along with any applicable fees.

09

Respond promptly to any requests for additional information or clarifications from the FDA during the review process.

10

If the IDE application is approved, ensure compliance with all regulations and reporting requirements throughout the investigational device study period.

11

Finally, conduct the study and collect data according to the approved IDE protocol, following ethical and scientific principles.

Who needs investigational device exemption ideide?

01

Investigational device exemption (IDE) is needed by entities or individuals who want to conduct clinical investigations involving medical devices that are not yet approved or cleared by the FDA.

02

Examples of those who may need IDE include device manufacturers, researchers, scientists, medical professionals, and academic institutions.

03

IDE allows for the investigational use of medical devices in order to collect data on safety and effectiveness for subsequent premarket applications (e.g., premarket approval (PMA), 510(k)).

04

It is important to note that certain limited exemptions exist for certain non-significant risk studies or investigations conducted in emergency situations.

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What is investigational device exemption ideide?

IDE is an investigational device exemption that allows the investigational device to be used in clinical studies in order to collect data on safety and efficacy.

Who is required to file investigational device exemption ideide?

The sponsor of the clinical study is required to file the IDE.

How to fill out investigational device exemption ideide?

The IDE application must be completed and submitted to the FDA for approval.

What is the purpose of investigational device exemption ideide?

The purpose of IDE is to ensure that the investigational device is safe and effective for its intended use.

What information must be reported on investigational device exemption ideide?

The IDE application must include information on the device, the clinical study protocol, and the qualifications of the investigators.

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