Research Turn Around Times - Investigational Device Exemptions

Question 1

21 CFR 812 (Investigational Device Exemptions): Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for (blank) following completion of the study.

Answer 1

1 year

Question 2

21 CFR 812 (Investigational Device Exemptions): An investigator or sponsor shall maintain the records required during the investigation and for a period of (blank) after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.

Answer 2

2 years

Question 3

21 CFR 812 (Investigational Device Exemptions): An investigator or sponsor may withdraw from the responsibility to maintain records and transfer custody of the records to any other person who will accept responsibility for them. Notice of a transfer shall be given to FDA no later than (blank) after transfer occurs.

Answer 3

10 working days

Question 4

21 CFR 812 (Investigational Device Exemptions): An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than (blank) after the investigator first learns of the effect.

Answer 4

10 working days

Question 5

21 CFR 812 (Investigational Device Exemptions): An investigator shall report to the sponsor, within (blank), a withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation.

Answer 5

5 working days

Question 6

21 CFR 812 (Investigational Device Exemptions): An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than (blank).

Answer 6

Yearly

Question 7

21 CFR 812 (Investigational Device Exemptions): 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. Such notice shall be given as soon as possible, but in no event later than (blank) after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB.

Answer 7

5 working days

Question 8

21 CFR 812 (Investigational Device Exemptions): If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within (blank) after the use occurs.

Answer 8

5 working days

Question 9

21 CFR 812 (Investigational Device Exemptions): An investigator shall, within (blank) after termination or completion of the investigation or the investigator’s part of the investigation, submit a final report to the sponsor and the reviewing IRB.

Answer 9

3 months

Question 10

21 CFR 812 (Investigational Device Exemptions): A sponsor who conducts an evaluation of an unanticipated adverse device
effect shall report the results of such evaluation to FDA and to all reviewing IRB’s and participating investigators within (blank) after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA requests.

Answer 10

10 working days

Question 11

21 CFR 812 (Investigational Device Exemptions): A sponsor shall notify FDA and all reviewing IRB’s and participating investigators of any withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within (blank) after receipt of the withdrawal of approval.

Answer 11

5 working days

Question 12

21 CFR 812 (Investigational Device Exemptions): 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 (blank) after receipt of notice of the withdrawal of approval.

Answer 12

5 working days

Question 13

21 CFR 812 (Investigational Device Exemptions): A sponsor shall submit to FDA, at (blank) intervals, a current list of the names and
addresses of all investigators participating in the investigation. The sponsor shall submit the first such list (blank) after FDA approval.

Answer 13

6 month, 6 months

Question 14

21 CFR 812 (Investigational Device Exemptions): At regular intervals, and at least (blank), a sponsor shall submit progress reports to all reviewing IRB’s. In the case of a significant risk device, a sponsor shall also submit progress reports to FDA. A sponsor of a treatment
IDE shall submit semi-annual progress reports to all reviewing IRB’s and FDA.

Answer 14

Yearly

Question 15

21 CFR 812 (Investigational Device Exemptions): A sponsor shall notify FDA and all reviewing IRB’s of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within (blank) after the request is made and shall state why the request was made.

Answer 15

30 working days

Question 16

21 CFR 812 (Investigational Device Exemptions): In the case of a significant risk device, the sponsor shall notify FDA within (blank) of the completion or termination of the investigation and shall submit a final report to FDA and all reviewing the IRB’s and participating investigators within (blank) after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB’s within (blank) after termination or completion.

Answer 16

30 working days; 6 months; 6 months

Question 17

21 CFR 812 (Investigational Device Exemptions): A sponsor shall submit to FDA a copy of any report by an investigator of use of a device without obtaining informed consent, within (blank) of receipt of notice of such use.

Answer 17

5 working days

Question 18

21 CFR 812 (Investigational Device Exemptions): If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB’s determination within (blank) after the sponsor first learns of the IRB’s determination.

Answer 18

5 working days

Question 19

21 CFR 812 (Investigational Device Exemptions): The requirements regarding FDA approval of a supplement do not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such deviation shall be reported to FDA within (blank) after the sponsor learns of it

Answer 19

5 working days

Question 20

21 CFR 812 (Investigational Device Exemptions): A sponsor may make certain changes without prior approval of a supplemental application if the sponsor determines that these changes meet the criteria, on the basis of credible information, and the sponsor provides notice to FDA within (blank) of making these changes.

Answer 20

5 working days

Question 21

21 CFR 812 (Investigational Device Exemptions): Changes meeting the criteria that are supported by credible information may be made without prior FDA approval if the sponsor submits a notice of the change to the IDE not later than (blank) after making the change. Changes to devices are deemed to occur on the date the device, manufactured incorporating the design or manufacturing change, is
distributed to the investigator(s). Changes to a clinical protocol are deemed to occur when a clinical investigator is notified by
the sponsor that the change should be implemented in the protocol or, for sponsor-investigator studies, when a sponsor investigator incorporates the change in the protocol. Such notices shall be identified as a “notice of IDE change.”

Answer 21

5 working days

Question 22

21 CFR 812 (Investigational Device Exemptions): Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for (blank) following completion of the study. This information shall not be submitted in an investigational device exemption application, but shall be submitted in any marketing application involving the device.

Answer 22

1 year

Question 23

21 CFR 812 (Investigational Device Exemptions): A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than (blank) after the sponsor makes this determination and not later than (blank) after the sponsor first received notice of the effect.

Answer 23

5 working days; 15 working days