21 CFR 890.5525 - Iontophoresis device.

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There is 1 rule appearing in the Federal Register for 21 CFR 890. View below or at eCFR (GPOAccess)
§ 890.5525 Iontophoresis device.
(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

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-04-14; vol. 79 # 71 - Monday, April 14, 2014
    1. 79 FR 20779 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective April 14, 2014.
      21 CFR Part 890

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 890 after this date.

  • 2014-04-14; vol. 79 # 71 - Monday, April 14, 2014
    1. 79 FR 20779 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective April 14, 2014.
      21 CFR Part 890