GroundRules
21 CFR 884.4250: Expandable cervical dilator.
Where this section sits in the code
- 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 E—Obstetrical and Gynecological Surgical Devices
(a) Identification. An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.
(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 expandable cervical dilator 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 an expandable cervical dilator that was in commercial distribution before May 28, 1976. Any other expandable cervical dilator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Collected 2026-08-27T02:24:47Z. Source file · JSON