21 CFR 812 Flashcards
What is 21 CFR Part 812 about?
IDEs (Investigational Device Exemptions)
Required parts of an IDE submission
- Cover letter
- Cross Reference Letter
- 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 info the FDA requests
- Information previously submitted to the FDA in accordance w/ 21 CFR 812
Device Risk Categories
- Significant Risk (SR) Device Investigations
- Nonsignificant Risk (NSR) Device Investigations
Who is responsible for determining the risk category for a device?
The sponsor-investigator is responsible for making the initial determination and submitting it to the IRB.
If the FDA has already made a risk determination that determination is final.
What is the difference in IDE requirements between a significant risk and non-significant risk device investigation?
A significant risk device investigation always requires an IDE. Nonsignificant risk investigations do not require an IDE.
What types of reports are required to be submitted to the FDA after an IDE is submitted and approved?
- Current Investigator List (every 6 months)
- Unanticipated Adverse Device Effects (UADEs) (w/in 10 working days)
- Annual Progress Report
- Final Report (w/in 6 months of study completion)
- Other required reports (withdrawal of IRB approval, recalls & device disposition, reports of device use w/o consent)
How often must a sponsor-investigator submit a current investigator list to the FDA for IDEs?
Every 6 months
What is the timeline for submitting Unanticipated Adverse Device Effects (UADEs) to the FDA?
w/in 10 working days after the sponsor receives notice of the effect.
When must a final report for an IDE be submitted?
W/in 6 months after study completion
What are the classes of medical devices?
-Class I - Lowest risk devices. Subject to general controls. Ex: surgical gloves and tongue depressors
- Class II - Moderate risk devices. Subject to general controls and special controls (e.g. FDA performance standards, post-market surveillance, etc). Ex: Flexible laryngoscopes and surgical drills
- Class III - Highest risk devices. Subject to stringent pre-market approval application. Generally: sustain or support life, are of substantial importance in preventing impairment of health, present a potential unreasonable risk of injury or illness. (E.g. artificial organs, replacement heart valves, pacemakers).
What are the qualities of a device under study that would qualify a clinical trial as a Significant risk (SR) Device Study?
- The device is intended as an implant and presents a potential for serious risk to health, safety, or welfare.
- Purported or represented to be for use in supporting or sustaining human life
- Is for use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health
- Otherwise presents a potential for serious risk to the health safety or welfare of the subject.
What is a PMA application for?
PMA = Premarket Approval. The FDA’s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
What are the exemptions for requirement of an IDE?
A device distributed before 28 May 1976 when used or investigated in accordance with the indications in labeling in effect at the time
A device introduced into commercial distribution after 28 May 1976 but is substantially equivalent to a device in distribution before that.
Diagnostic devices (if sponsor complies with 21 CFR 809) and testing:
- Is non-invasive
- Does not require invasive sampling w/significant risk
- Does not introduce energy into a subject
- Not used as a diagnostic procedures w/o confirmation by another established diagnostic test or procedure
Device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for safety or effectiveness
Devices for veterinary use
Devices shipped for research on or use w/lab animals
A custom device, unless being used to test safety or effectiveness for commercial distribution
When can a device qualify for an abbreviated IDE?
Device was studied before 7/1980 and studies ended before 1/1981
A device that isn’t significant risk, is not banned, and the sponsor:
- Labels the device per 21 CFR 812
- Subjects have documented consent (unless waived)
- Investigations are monitored per 21 CFR 812
- Records are maintained and reports completed per 21 CFR 812
- Complies with prohibitions in 21 CFR 812 against promotion and other practices
How long does the FDA have to respond to an IDE application?
30 days from receipt, after that approval is assumed
