21 CFR § 882.4565 - Field generator positioning device.

---
identifier: "/us/cfr/t21/s882.4565"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.4565 - Field generator positioning device."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.4565"
section_name: "Field generator positioning device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 882.4565 Field generator positioning device.

(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.

[90 FR 54234, Nov. 26, 2025]