Page 60 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 39

The other major parties to a clinical study are the sponsor and the investigator. The sponsor is the
party responsible for the study, which usually involves funding the study. In normal commercial
studies designed to get products approved by FDA, a commercial entity, the medical device manu-
facturer, is the sponsor. The investigators are experienced medical practitioners with whom the spon-
sor contracts to do the study. However, any combination is possible. For example, it is common to
have a medical researcher be both a sponsor and investigator of an academic research study. The key
issue is that the sponsor and the investigator must be identified and it must be made clear who is sat-
isfying the requirements of the various regulations.
Federal regulations control the sponsor and investigator in their conduct of the study. For medical
devices the main rule is in 21 C.F.R. 812. There is no name for this regulation, as we saw for GLP.
Some use the term Good Clinical Practices (GCP) but it is an informal term, covering the mélange
of regulations we have discussed.
Part 812 lays out the duties of the sponsor:

Sec. 812.40 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators and providing them with the information
they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring
that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any
reviewing IRB and FDA are promptly informed of significant new information about an investigation.
Additional responsibilities of sponsors are described in subparts B and G.
Sec. 812.42 FDA and IRB approval.
A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have
both approved the application or supplemental application relating to the investigation or part of an
investigation.
Sec. 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to
investigate the device.
(b) Control of device. A sponsor shall ship investigational devices only to qualified investigators partici-
pating in the investigation.
(c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement
that includes:
(1) The investigator’s curriculum vitae.
(2) Where applicable, a statement of the investigator’s relevant experience, including the dates, loca-
tion, extent, and type of experience.
(3) If the investigator was involved in an investigation or other research that was terminated, an
explanation of the circumstances that led to termination.
(4) A statement of the investigator’s commitment to:
(i) Conduct the investigation in accordance with the agreement, the investigational plan, this
part and other applicable FDA regulations, and conditions of approval imposed by the
reviewing IRB or FDA;
(ii) Supervise all testing of the device involving human subjects; and
(iii) Ensure that the requirements for obtaining informed consent are met.
(5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and
accurate certification or disclosure statement as required under part 54 of this chapter. The spon-
sor 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 1 year following com-
pletion 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.
(d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor
the investigational study in accordance with this part and other applicable FDA regulations.
Sec. 812.45 Informing investigators.
A sponsor shall supply all investigators participating in the investigation with copies of the investiga-
tional plan and the report of prior investigations of the device.