Page 62 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 41

(1) Exempt studies
There are various types of studies that are exempt from Part 812 and need no FDA interaction:
(a) Preamendment devices which were on sale before 1976 and are used under their original
indications.
(b) 510(k) devices, used under their cleared indications for use. Using a device in its normal
commercially labeled manner is not a clinical test.
(c) Diagnostic devices, if the testing is noninvasive: does not require an invasive sampling pro-
cedure; does not, by design or intention, introduce energy into a subject; and is not used as
a diagnostic without confirmation of the diagnosis by another medically established diag-
nostic product or procedure.
(d) Devices undergoing consumer preference testing if they are not for purposes of determining
safety or effectiveness and does not put subjects at risk. This sounds at first to be a broad cat-
egory, but actually most tests are, in some way, designed to determine safety or effectiveness.
(e) Devices for veterinary use.
(f) Devices for animal testing.
(g) Custom devices.
(2) IDE studies
These are for the highest risk devices. This requires a full submission to FDA.
(3) Abbreviated IDE studies or nonsignificant risk (NSR) studies
These are studies of devices that do not present significant risk, that is, the device is not an
implant, does not present a serious risk to health, and is not for curing or preventing a disease or
impairment to human health. You must have a determination from the relevant IRB that the
device is not a significant risk.
You still have to follow some basic requirements of Part 812, such as monitoring, but you do
not have to apply to FDA for an IDE.
The IDE process involves a sponsor submitting an application to FDA including
(1) The name and address of the sponsor.
(2) A complete report of prior investigations of the device and an accurate summary of those sec-
tions of the investigational plan described in 812.25(a) through (e) or, in lieu of the summary,
the complete plan. The sponsor shall submit to FDA a complete investigational plan and a com-
plete report of prior investigations of the device if no IRB has reviewed them, if FDA has found
an IRB’s review inadequate, or if FDA requests them.
(3) A description of the methods, facilities, and controls used for the manufacture, processing, pack-
ing, storage, and, where appropriate, installation of the device, in sufficient detail so that a per-
son generally familiar with good manufacturing practices can make a knowledgeable judgment
about the quality control used in the manufacture of the device.
(4) An example of the agreements to be entered into by all investigators to comply with investiga-
tor obligations under this part, and a list of the names and addresses of all investigators who have
signed the agreement.
(5) A certification that all investigators who will participate in the investigation have signed the agree-
ment, that the list of investigators includes all the investigators participating in the investigation,
and that no investigators will be added to the investigation until they have signed the agreement.
(6) A list of the name, address, and chairperson of each IRB that has been or will be asked to
review the investigation and a certification of the action concerning the investigation taken by
each such IRB.
(7) The name and address of any institution at which a part of the investigation may be conducted
that has not been identified in accordance with paragraph (b)(6) of this section.
(8) If the device is to be sold, the amount to be charged and an explanation of why the sale does not
constitute commercialization of the device.
(9) A claim for categorical exclusion or an environmental assessment.
(10) Copies of all labeling for the device.
(11) Copies of all forms and informational materials to be provided to subjects to obtain informed
consent.
(12) Any other relevant information FDA requests for review of the application.
Id. § 812.20.