(a)Iontophoresis device intended for certain specified uses—
(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.
(2)Classification. Class II (performance standards).
(b)Iontophoresis device intended for any other purposes—
(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes other than those specified in paragraph (a) of this section.
(2)Classification. Class III (premarket approval).
(c)Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Title 21 published on 2014-04-01
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