21 CFR Part 812 Flashcards
What is CFR 21 Part 812
Investigational Device Exemptions
What is a significant risk device?
A device that: 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?
a device subject to 520(l) of the act that is a device that FDA considered to be a new drug or antiboitic before MAY 28 1976.
What is a device?
A device, other than a transitional device, in commercial distribution immediately before May 28 1976 when used for investigated in accordance with the indications in labeling in effect at that time.
Investigational Plan should include:
a) purpose
b) protocol
c) risk analysis
d) description of device
e) monitoring procedures.
f) labeling
g) consent materials
h) IRB information
i) Other institutions
j) additional records and reports.
What types of changes would require a supplemental application?
1) Changes in investigational plan
2) Changes effected for emergency use
3) Changes effected with notice to FDA within 5 days.
4) Changes submitted in annual report.
Can a sponsor make certain changes without prior approval of a supplemental application?
Yes – but the sponsor must notified the FDA within 5 days of the changes going in to effect.
What types of changes can the sponsor make w/o prior 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?
· An approved IDE permits a device to be shipped lawfully for the purposes of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution.
