Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 882</CFR> <DEPDOC>[Docket No. FDA-2025-N-4680]</DEPDOC> <SUBJECT>Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; final order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is classifying the field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective November 26, 2025. The classification was applicable on July 10, 2020. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Payton Lin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1212, Silver Spring, MD 20993-0002, 240-402-6580, <E T="03">Payton.Lin@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Upon request, FDA has classified the field generator positioning device as class I (general controls), which we have determined will provide a reasonable assurance of safety and effectiveness for its intended use. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into the appropriate device class based on risk and the regulatory controls sufficient to provide reasonable assurance of safety and effectiveness. FDA may classify a device through an accessory classification request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision allows manufacturers or importers to request classification of an accessory distinct from another device upon written request. The classification is based on the risks of the accessory when used as intended as well as the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, notwithstanding the classification of any other device with which such accessory is intended to be used. Until an accessory is reclassified by FDA, the classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, will continue to apply. Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or importer may request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. FDA must grant or deny the request not later than 85 days after receipt and, if granting, publish a notice in the <E T="04">Federal Register</E> within 30 days of announcing the classification. Alternatively, under section 513(f)(6)(C), a person filing a PMA or 510(k) may include a written request for the proper classification of an accessory that has not been classified distinctly from another device based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. When the written request is included in a submission for marketing authorization, FDA must grant or deny the request along with the response to the PMA or 510(k). Upon granting, FDA will publish a notice in the <E T="04">Federal Register</E> within 30 days of announcing the classification. <HD SOURCE="HD1">II. Accessory Classification</HD> On April 17, 2020, FDA received Stryker ENT's request for accessory classification of the TGS Universal Headrest with Mounting Arm. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class I if general controls are sufficient to provide reasonable assurance of safety and effectiveness of the device for its intended use (see section 513(a)(1)(A) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class I (general controls). FDA has determined that general controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on July 10, 2020, FDA issued an order to the requester classifying the device into class I. In this final order, FDA is codifying the classification of the device by adding 21 CFR 882.4565. <SU>1</SU> <FTREF/> We have named the generic type of device “field generator positioning device,” and it is identified as 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. <FTNT> <SU>1</SU>  FDA notes that the <E T="02">ACTION</E> caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. </FTNT> FDA has identified the following risks to health associated specifically with this type of device: mechanical failure (which could damage the field generator or cause the device to physically impact the patient), interference from items within the projected field, or movement of the electromagnetic field projection. Section 510(l)(1) of the FD&C Act provides that a device within a type that has been classified into class I under section 513 of the FD&C Act is exempt from premarket notification under section 510(k), unless the device is of substantial importance in preventing impairment of human health or presents a potentially unreasonable risk of illness or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt from the premarket notification requirements under section 510(k), subject to the limitations of exemptions in 21 CFR 882.9. <HD SOURCE="HD1">III. Analysis of Environmental Impact</HD> The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. <HD SOURCE="HD1">IV. Paperwork Reduction Act of 1995</HD> This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in the guidance document “Medical Device Accessories—Describing Accessories and Classification Pathways” have been approved under OMB control number 0910-0823; the collections of information in part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 regarding quality system regulation have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; and the collections of information in part 801 regarding labeling have been approved under OMB control number 0910-0485. <LSTSUB> <HD SOURCE="HED">List of Subjects in 21 CFR Part 882</HD> Medical devices. </LSTSUB> Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: <HD SOURCE="HED">PART 882—NEUROLOGICAL DEVICES</HD> <REGTEXT TITLE="21" PART="882"> 1. The authority citation for part 882 continues to read as follows: <HD SOURCE="HED">Authority: </HD> 21 U.S.C. 351, 360, 360c, 360e, 360j, <E T="03">360l,</E> 371. </REGTEXT> <REGTEXT TITLE="21" PART="882"> 2. Add § 882.4565 to subpart E to read as follows: <SECTION> <SECTNO>§ 882.4565</SECTNO> <SUBJECT>Field generator positioning device.</SUBJECT> (a) <E T="03">Identification.</E> 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) <E T="03">Classification.</E> 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. </SECTION> </REGTEXT> <SIG> <NAME>Lowell M. Zeta,</NAME> Acting Deputy Commissioner for Policy, Legislat ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 10k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━