Page 48 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 27

then, for purposes of this section and sections 360d and 360e of this title, the Secretary may authorize the
effectiveness of the device to be determined on the basis of such evidence.
(C) In making a determination of a reasonable assurance of the effectiveness of a device for which
an application under section 360e of this title has been submitted, the Secretary shall consider
whether the extent of data that otherwise would be required for approval of the application with
respect to effectiveness can be reduced through reliance on postmarket controls.
(D)
(i) The Secretary, upon the written request of any person intending to submit an application
under section 360e of this title, shall meet with such person to determine the type of valid
scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be neces-
sary to demonstrate for purposes of approval of an application the effectiveness of a device
for the conditions of use proposed by such person. The written request shall include a
detailed description of the device, a detailed description of the proposed conditions of use
of the device, a proposed plan for determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the expected performance from the
device. Within 30 days after such meeting, the Secretary shall specify in writing the type of
valid scientific evidence that will provide a reasonable assurance that a device is effective
under the conditions of use proposed by such person.
(ii) Any clinical data, including one or more well-controlled investigations, specified in writing
by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be
specified as result of a determination by the Secretary that such data are necessary to estab-
lish device effectiveness. The Secretary shall consider, in consultation with the applicant,
the least burdensome appropriate means of evaluating device effectiveness that would have
a reasonable likelihood of resulting in approval.
(iii) The determination of the Secretary with respect to the specification of valid scientific evidence
under clauses (i) and (ii) shall be binding upon the Secretary, unless such determination by the
Secretary could be contrary to the public health.
Id. § 360c.

Class III includes active implantables such as pacemakers, implantable cardioverter/defibrillators,
neurological spine brain stimulators, and implantable brain stimulators. It also includes passive
implantables, such as heart valves.

Class II
(B) Class II, Special Controls.—A device which cannot be classified as a Class I device because the general
controls by themselves are insufficient to provide reasonable assurance of the safety and effective-
ness of the device, and for which there is sufficient information to establish special controls to provide
such assurance, including the promulgation of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines (including guidelines for the submission of
clinical data in Premarket Notification submissions in accordance with section 360 (k) of this title), rec-
ommendations, and other appropriate actions as the Secretary deems necessary to provide such assur-
ance. For a device that is purported or represented to be for a use in supporting or sustaining human life,
the Secretary shall examine and identify the special controls, if any, that are necessary to provide ade-
quate assurance of safety and effectiveness and describe how such controls provide such assurance.
Id.

Class II includes the vast bulk of diagnostic and external therapeutic devices. The wide array of
monitors, IV pumps, etc., seen walking down a hospital corridor are mostly Class II devices.

Class I
(A) Class I, General Controls.—
(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i,
or 360j of this title or any combination of such sections are sufficient to provide reasonable
assurance of the safety and effectiveness of the device.