21 CFR 878.1800 - Speculum and accessories.

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§ 878.1800 Speculum and accessories.

(a)Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[ 53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 878 after this date.

  • 2016-12-19; vol. 81 # 243 - Monday, December 19, 2016
    1. 81 FR 91722 - Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective on January 18, 2017.
      21 CFR Parts 878, 880, and 895