CFR 21 Part 812 Flashcards
(43 cards)
What does 45 CFR Part 812 cover
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 purported 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 diagnosing, 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
4) Otherwise presented a potential for serious risk to the health safety, or welfare of a subject.
Transitional Device
Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
Any device that was approved by the New Drug Application process is now governed by the PMA regulations. The original NDA approval number is maintained.
What types of changes would require a pre-approval of supplemental application? (IDE)
a) Changes in Investigational Plan – most of the time, changes that are made in the Investigational Plan, need to be pre-approved by FDA. Examples of these changes are:
1. Changes in the Investigational Plan or Protocol
-Affecting the validity of data/information,
-Patient risk to benefit relationship,
-Scientific soundness of investigational plan,
-Right, safety or welfare of subjects.
2. Developmental Changes that present a significant change in design or basic principle of operation
3. IRB approval of new facility-a Sponsor
Exceptions to the pre-approval requirements are:
- Changes Effected for Emergency Use-are considered to be changes in the investigational plan to protect the life or well-being of the subject in the case of
emergency. However, these changes must be reported to the FDA within 5- working days. - Non-significant changes in design or manufacturing - those changes should also be reported to the FDA within 5-working days.
- Other minor changes that could be reported as a part of Progress Report
Can a sponsor make certain changes without prior approval of a supplemental application? If so what is the timeline?
Yes – 1. Changes Effected for Emergency Use-are considered to be changes in the investigational plan to protect the life or well-being of the subject in the case of emergency.
2. Non-significant changes in design or manufacturing
Imp: Sponsor must notify FDA within 5 working days
For a significant risk device, the sponsor must notify FDA and all reviewing IRBs within …..days of the completion or termination of the investigation.
30 working days
For a significant risk device, the sponsor must submit a final report to FDA and all reviewing IRBs and participating investigators within….. after the completion or termination of the investigation.
6 months
For a nonsignificant risk device, the sponsor must submit a final report to all reviewing IRBs within…… after completion or termination.
6 months
Define “Treatment use of an investigational device”
A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available.
Treatment use of an investigational device
During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial under the provisions of a treatment investigational device exemption (IDE).
FDA shall consider the use of an investigational device under a treatment IDE if:
(1) The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition;
(2) There is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition in the intended patient population;
(3) The device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed; and
(4) The sponsor of the investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence.
What is IDE
An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
An IDE approved under §812.30 or considered approved under §812.2(b) exempts a device from the requirements of the sections of
Federal Food, Drug, and Cosmetic Act (the act) and regulations
The investigator shall submit to …..and … a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than …working days after the investigator first learns of the effect.
a) the sponsor b) the reviewing IRB c) 10
An investigator shall report to the …… within …… working days, a withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation
a) Sponsor, b) 5
True/False. An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.
True; Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred
If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within …working days after the use occurs.
5
The sponsor who conducts an evaluation of an unanticipated adverse device effect ) shall report the results of such evaluation to…..within … working days after the sponsor first receives notice of the effect.
1) FDA and to all reviewing IRB’s and participating investigators
2) 10
The sponsor shall notify…. of any
withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within… working days after receipt of the withdrawal of approval.
1) FDA and all reviewing IRB’s and participating investigators
2) 5
A sponsor shall notify all reviewing IRB’s and participating investigators of any withdrawal of FDA approval of the investigation, and shall do so within….. working days after receipt of notice of the withdrawal of approval.
5
A sponsor shall submit to FDA current list of the names and addresses of all investigators participating in the investigation.
True; at 6 months intervals
Recall and device disposition: A sponsor shall notify ….of any request that an investigator return, repair, or otherwise dispose of any units of a device within ….. working days after the request is made and shall state why the request was made.
1) FDA and all reviewing IRB’s
2) 30
A sponsor shall submit to FDA a copy of any report by an investigator of use of a device without obtaining informed consent, within …working days of receipt of notice of such use.
5
