Title 21, Part 812 - Investigational Device Exemption Flashcards
Waivers
Sponsors may request the FDA to waive any requirement of this part
Who submits an IDE application to the FDA
A sponsor
Contents of an IDE in order
- Name and address of sponsor
- A complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan
- A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of device
- An example of agreements to be enterd into by all investigators to comply with investigator obligations
- A certification that all investigators who will participate in the investigation have signed the agreement, the list of investigators participating in the investigation, and that no investigators will be added after the agreement is signed
- A list of name, address, of each chairperson of each IRB
- The name and address of any institution in which the investigation may be conducted
- If the device is cold, the amount charged and an explanation
- A claim for categorical exclusion
- Copies of all labeling for a device
- Copies of all forms and informational materials to be provided to subjects to obtain informed consent
- Any other relevant information the FDA requests for review of an application
Investigational plan in order
- Purpose
- Protocol
- Risk Analysis
- Description of Device
- Monitoring Procedures
- Labeling
- Consent Materials
- IRB Information
- Other Institutions
- Additional Records and Reports
How does the FDA notify the sponsor whether or not they approve/disapprove their application
The FDA notifies the sponsor in writing
They will approve an investigation as proposed, approve it with modifications, or disapprove it
FDA Approval Timeline
- Thirty days AFTER FDA receives the application
- FDA approves IDE
Treatment Use of an Investigational Device
The FDA will consider the use of an investigational device under treatment if:
- The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition
- There is no comparable or satisfactory alternative device or other therapy available
- The device is under investigation in a controlled clinical trial for the same use under an approved IDE
- The sponsor of the investigation is actively pursuing marketing approval/clearance
General Responsibilities of Sponsors - IDE
- Selecting qualified investigators and providing them with the information they need to conduct the investigation properly
- Ensuring proper monitoring
- Ensuring that IRB review and approval are obtained
- Submitting an IDE application to the FDA
- Ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation
SAME respinsibilites as sponsor in an IND application EXCEPT #3
Who reports Unanticipated Adverse Device Effects?
Sponsor
IRB Duties - IDE Application
- The IRB shall approve, require modifications in, or disapprove all investigations
- The IRB shall conduct a continuing review
- Significant Risk Device Determinations
Responsibilities of Investigator - IDE
- Ensuring the investigation is conducting according to the signed agreement, the investigational plan, and applicable FDA regulations
- Protecting the rights, safety, and welfare of subjects under the investigators care
- Responsible for the control of devices under the investigation
- Ensuring informed consent is obtained
*same responsibilities of an investigator in an IND application
What are the records an investigator is responsible for maintaining?
- All correspondence with everyone (another investigator, the sponsor, the monitor, or the FDA
- Records of receipt, use, or disposition of a device
- REcords of each subject’s case history and exposure to the device
- The protocol, with documents showing the dates of and reasons for each deviation from the protocol
- Any other records that FDA requires to be maintained by regulation or by specific requirement
What are the records a sponsor is responsible for maintaining?
- All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA
- Records of shipment and disposition
- Signed investigator agreements including the financial disclosure information
- SR/NSR determinations
- Records concerning adverse device effects
- Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation
How long should a sponsor or an investigator, maintain their records?
2 years
Who and When should Unanticipated Adverse Device Effects?
-An investigator submits to the sponsor AND to the reviewing IRB
-ASAP or within 10 days
Who and When is in charge of Withdrawing IRB Approval?
-An investigator shall report to the sponsor
-Within 5 working days
Who and When handles the submission of progress reports?
-An investigator submits progress reports to the sponsor, the monitor, and the reviewing IRB regularly, or in no event less often than yearly
Who and When are Deviations from the Investigational Plan reported?
-An investigator shall notify the sponsor and the reviewing IRB
-ASAP, or within 5 working days
Who and when reports if an informed consent is not obtained prior to the use of a device
-The investigator shall report this within 5 working days
Who and when submits the final report during an IDE
The investigator shall submit the final report to the sponsor and the reviewing IDE
-The final report should be submitted within 3 months, after termination or completion of the investigation
