21 CFR part 812 Flashcards
CFR 21 part 812 covers:
investigational device exemptions
what is a significant risk device?
1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; 2) Is purpoted or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject. 3) is for a use of substantial importance in diagnosising, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. or 4) Otherwise presented a potential for serious risk to the health safety, or welfare of a subject.
what is a transitional device?
one that is subject to 520(I) of the act that is a device the FDA considers to be a new drug or antibiotic before 5/28/76
what should an investigational plan include? (10)
1) purpose
2) protocol
3) risk analysis
4) description of device
5) monitoring procedures
6) labeling
7) consent materials
8) IRB info
9) other institutions
10) additional records and reports
what types of change would require supplemental application?
1) investigational plan
2) those effected for emergency use
3) those effected with notice to FDA within 5 days
4) submitted in annual report
can a sponsor make changes without prior approval of a supplemental application?
yes, but the must notify FDA within 5 days of the changes going into effect
what types of changes can the sponsor make without approval on a supplemental application?
1) Developmental changes, including manufacturing changes that do not constitute a significant change in design or basic operation and are made based on basic information gathered during the investigation.
2) Changes to clinical protocol that do not affect validity of data, scientific soundness, or the rights safety, and welfare of human subject.
3) Definition of credible information
4) Notice of IDE change
what are the responsibilities of sponsors as outlined in subpart C?
1) Gaining FDA and IRB approval before beginning the investigation
2) Selecting investigators and monitors
3) Informing investigators
4) monitoring investigations
5) Emergency Research
responsibilities of investigators as outlined in subpart E?
1) Awaiting approval.
2) Compliance.
3) Supervising device use.
4) Financial disclosure.
5) Disposing of device.
what does an approved IDE permit?
a device to be shipped lawfully for the purposes of conducting investigations of the device without complying with other requirements of the FDA that would apply to devices in commercial distribution
