21 CFR Part 812 Flashcards
What does 21 CFR part 812 apply to?
Investigational Devices
What should be included in an IDE submission?
-Cover letter to the FDA
-Cross-reference letter from device supplier*
-Table of contents
-Report of prior investigations*
-Investigational plan
-Manufacturing information*
-Investigator information**
-IRB information
-Sales information
-Device labeling
-Informed consent materials
-Any other relevant information that FDA requests for review of the IDE application
-Information previously submitted to FDA in accordance with 21 CFR 812 may be incorporated by reference
Do significant risk (SR) device studies need to be performed under an IDE?
All significant risk device studies must be performed under an IDE
Do nonsignificant risk (NSR) device studies need to be performed under an IDE?
Nonsignificant risk device studies do not need to be performed under an IDE. IRB approval, informed consent, and appropriate monitoring of the study are required for most NSR studies.
Who is responsible for making a NSR/SR determination?
The sponsor makes the initial assessment and provides it to the IRB, who can disagree. The FDA can help the sponsor-investigator or the IRB make a decision. If the FDA makes a determination before the IRB the FDA’s determination is final.
What are the responsibilities of a sponsor-investigator?
-Implement research as approved
-Select qualified investigators
-Ensure proper monitoring of the study
-Inform the IRB and FDA of any significant new information
How often should the current investigator list be submitted to the FDA?
A current list of the names and addresses of all investigators participating in the investigation are submitted to FDA at six (6)-month intervals starting from the date of approval.
How quickly should unanticipated adverse device effects (UADEs) be submitted to the FDA?
Unanticipated adverse device effects are submitted to the FDA within ten (10) working days after the sponsor first receives notice of the effect.
When should a final study report be submitted to the FDA?
A final study report is to be submitted to the FDA within six (6) months after the study is completed.
Class 1 devices
The lowest risk devices and are governed by general controls. Examples of Class I devices are surgical gloves and tongue depressors.
Class 2 devices
Moderate risk devices and are subject to both general controls and special controls such as specific FDA performance standards, post-market surveillance, or special control guidance to ensure their safety and effectiveness. Examples of Class II devices are flexible laryngoscopes and surgical drills.
Class 3 devices
The highest risk devices. General controls and special controls alone are not adequate to ensure their safety and effectiveness. These devices therefore require a stringent premarketing approval application to be filed before they can be sold in the U.S. They generally are devices that:
-Support or sustain life
-Are of substantial importance in preventing impairment of health
-Present a potential, unreasonable risk of injury or illness
Examples of Class III devices are artificial organs, replacement heart valves, and pacemakers.
What is an SR device study?
A clinical trial of a device that:
-is an implant and carries risk
-is for use in supporting human life and carries risk
-is for diagnosing/helping treat disease and carries risk
Is premarket notification and application to the FDA for exempt devices required?
No. Instead, the manufacturer is required to register its establishment and list its generic product with the FDA.
When might an investigational device be exempt?
1) device that has been in distribution before 1976
2) a non-invasive diagnostic device that does not introduce energy or act as the sole diagnostic criteria (other criteria must be medically established)
3) customer preference testing that is safe
4) devices for animals
5) custom devices (like a custom wheelchair)
