21 CFR 884.2685 - Fetal scalp clip electrode and applicator.

§ 884.2685 Fetal scalp clip electrode and applicator.
(a) Identification. A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin and an external monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used to obtain a fetal electrocardiogram. This generic type of device may include a clip electrode applicator.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any fetal scalp clip electrode and applicator that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a fetal scalp clip electrode and applicator that was in commercial distribution before May 28, 1976. Any other fetal scalp clip electrode and applicator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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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 884 after this date.

  • 2014-05-01; vol. 79 # 84 - Thursday, May 1, 2014
    1. 79 FR 24634 - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments on this proposed order by July 30, 2014. Please see section XIII for the proposed effective date of any final order that may publish based on this proposal.
      21 CFR Part 884