United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-04-16 article Rules and Regulations D09002ee1e0aaf638 D09002ee1e0aaf6ca United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices. 91 FR 20352 https://www.govinfo.gov/app/details/FR-2026-04-16/2026-07366 2026-07366 fr16ap26-12 4164-01-P Docket No. FDA-2020-N-1053 https://www.govinfo.gov/app/details/FR-2026-04-16/2026-07366 https://www.govinfo.gov/content/pkg/FR-2026-04-16/html/2026-07366.htm https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07366.pdf Medical Devices 11 p. 20352 20362 91 FR 20352 Title 21 Part 890 21 CFR Part 890 Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators; Federal Register Vol. 91, Issue RULE 2026-07366 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-05-18 Docket No. FDA-2020-N-1053 4164-01-P 2026-07366 Final amendment; final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.

This order is effective May 18, 2026. John Gomes, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4564, Silver Spring, MD 20993, 301-796-5618, John.Gomes@fda.hhs.gov. Medical Devices Physical Medicine Devices Reclassification of Non-Invasive Bone Growth Stimulators, John.Gomes@fda.hhs.gov https://webstore.iec.ch/en/publication/2590 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190030 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210016 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210035 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230025 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-8-9-2020-orthopaedic-and-rehabilitation-devices-panel-medical-devices-advisory-committee https://www.fda.gov/media/145159/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program https://www.regulations.gov www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff Vol. 91, no. 73 Office of the Federal Register, National Archives and Records Administration 2026-04-16 continuing daily deposited born digital 270 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-04-16 P0b002ee1e0aaed14 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16ap26 https://www.govinfo.gov/app/details/FR-2026-04-16 https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/FR-2026-04-16.pdf https://www.govinfo.gov/content/pkg/FR-2026-04-16/xml/FR-2026-04-16.xml fdlp 20317 20576 DGPO 2026-04-16 2026-04-16 FR-2026-04-16 machine generated eng FR FR-2026-04-16 91 73