CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR884.2050]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart C - Obstetrical and Gynecological Monitoring Devices

Sec. 884.2050 Obstetric data analyzer.

(a) Identification. An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic interfaces for other equipment, and power supplies and component parts.

(b) Classification: Class III (premarket approval).

(c) Date PMA or notice of completion of 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 October 3, 2000, for any obstetric data analyzer described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has been found, on or before October 3, 2000, to be substantially equivalent to an obstetric data analyzer described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other obstetric data analyzer described in paragraph (a) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[65 FR 41332, July 5, 2000]