GroundRules
21 CFR 882.4565: Field generator positioning device.
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 882—NEUROLOGICAL DEVICES
- Subpart E—Neurological Surgical Devices
(a) Identification. A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.
(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 § 882.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON