GroundRules
21 CFR 888.4600: Protractor for clinical use.
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 888—ORTHOPEDIC DEVICES
- Subpart E—Surgical Devices
(a) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
(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 § 888.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON