Get the free Supplemental Form for Investigational Devices - etsu

This form is used to outline the responsibilities of investigators conducting research involving investigational devices, detailing security and storage plans, access accountability, and maintenance

How to fill out supplemental form for investigational

How to fill out Supplemental Form for Investigational Devices

1. Begin by downloading the Supplemental Form for Investigational Devices from the regulatory agency's website.
2. Review the instructions carefully to understand the requirements and sections of the form.
3. Fill out the applicant information section with your name, address, and contact details.
4. Provide details about the investigational device, including its name, intended use, and unique identification number.
5. Document the device's manufacturing information, including the name and location of the manufacturer.
6. Describe the indications for use and patient population targeted for the investigational device.
7. Complete the section regarding previous submissions and approvals related to the device, if applicable.
8. Include any relevant clinical study data or previous study results related to the device.
9. Attach necessary supporting documents, such as study protocols and informed consent forms.
10. Review the completed form for accuracy and completeness before submission.
11. Submit the form along with any associated fees as directed by the regulatory agency.

Who needs Supplemental Form for Investigational Devices?

1. Research institutions and clinical trial sponsors conducting studies involving investigational devices.
2. Manufacturers seeking approval or clearance for new investigational devices.
3. Healthcare providers involved in clinical trials for new devices.

People Also Ask about

How long does it take to get IDE approval?

Once the initial IDE submission has been sent to the FDA, a team of staff reviews the IDE and provides one of several standard responses within 30 days of receipt. For additional information, see FDA's Guidance document entitled FDA Decisions for Investigational Device Exemption Clinical Investigations.

What is the difference between IDE amendment and supplement?

Supplement - An IDE supplement is any additional submission to an IDE after approval of the IDE. WHAT KIND OF AMENDMENTS CAN OCCUR? It is possible that you may need to submit items to your IDE while it is still under initial review. These submissions are technically called 'amendments'.

What is an IND device?

As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans.

What is an example of investigational device exemption?

The study can be exempt if energy is introduced as a part of clinical care and there is no additional energy introduced because of the study. For example, if the investigational diagnostic device is applied to X-ray images collected as a part of clinical care, then the study can be exempt.”

How long does it take to get an IDE?

Once the initial IDE submission has been sent to the FDA, a team of staff reviews the IDE and provides one of several standard responses within 30 days of receipt.

How long does it take to get FDA approved?

Depending on the risk associated with your device, the medical device approval process can take anywhere from 90 to 180 days. However, it's important to note that these numbers can be (and often are) increased if FDA requires a written response or additional information from the manufacturer.

For pdfFiller’s FAQs

What is Supplemental Form for Investigational Devices?

The Supplemental Form for Investigational Devices is a document required by regulatory authorities that provides additional information and details regarding investigational medical devices being tested in clinical trials.

Who is required to file Supplemental Form for Investigational Devices?

Sponsors and investigators involved in clinical trials of investigational devices are required to file the Supplemental Form for Investigational Devices.

How to fill out Supplemental Form for Investigational Devices?

To fill out the Supplemental Form for Investigational Devices, one must provide accurate data regarding the device, study protocol, subject information, and any amendments or significant changes to the study.

What is the purpose of Supplemental Form for Investigational Devices?

The purpose of the Supplemental Form for Investigational Devices is to ensure that the regulatory authorities have all pertinent information to assess the safety and effectiveness of the investigational device during the clinical trial.

What information must be reported on Supplemental Form for Investigational Devices?

The information that must be reported includes device description, clinical study design, risk assessment, participant demographics, protocols for data collection, and any adverse events or outcomes observed during the study.