{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.","action":"Final amendment; final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/08/17/2026-16727.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"864","title":21}],"citation":"91 FR 53184","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 16, 2026. See further discussion in section IV, \"Implementation Strategy.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-1243"],"dockets":[{"supporting_documents":[{"title":"Reference 4 - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Guidance","document_id":"FDA-2025-N-1243-0026"},{"title":"Reference 3 - Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices Guidance for Industry","document_id":"FDA-2025-N-1243-0025"},{"title":"Reference 2 - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions","document_id":"FDA-2025-N-1243-0024"},{"title":"Reference 1 - Requests for Feedback and Meetings for Medical Device Submissions The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2025-N-1243-0023"},{"title":"List of References","document_id":"FDA-2025-N-1243-0022"},{"title":"Reference 14 - Bauman JG, Wiegant J, Borst P, van Duijn P. A new method for fluorescence microscopical localization of specific DNA sequences by in situ hybridization of fluorochromelabelled RNA","document_id":"FDA-2025-N-1243-0016"},{"title":"Reference 13 - Manning JE, Hershey ND, Broker TR, Pellegrini M, Mitchell HK, Davidson N. A new method of in situ hybridization","document_id":"FDA-2025-N-1243-0015"},{"title":"Reference 12 - du Sart, D., Andy Choo, K.H. (1998). The Technique of In Situ Hybridization. In: Rapley, R., Walker, J.M. (eds) Molecular Biomethods Handbook. Springer Protocols Handbooks","document_id":"FDA-2025-N-1243-0014"},{"title":"Reference 11- Chu YH, Hardin H, Zhang R, Guo Z, Lloyd RV. In situ hybridization: Introduction to techniques, applications and pitfalls in the performance and interpretation of assays","document_id":"FDA-2025-N-1243-0013"},{"title":"Reference 10 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. National Center for Health Statistics. Vital Health Stat 73(4). 2024","document_id":"FDA-2025-N-1243-0012"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-17","updated_at":"2026-08-17T09:56:40.646-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-1243-0021","allow_late_comments":false,"id":"FDA-2025-N-1243-0021","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":20,"id":"FDA-2025-N-1243","title":"Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product"}],"document_number":"2026-16727","effective_on":"2026-09-16","end_page":53191,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/17/2026-16727.xml","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16727?publication_date=2026-08-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-17/2026-16727/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":1858,"last_updated":"2026-09-20 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16727.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16727.pdf?1786711515","publication_date":"2026-08-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/17/2026-16727.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 4 - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Guidance","document_id":"FDA-2025-N-1243-0026"},{"title":"Reference 3 - Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices Guidance for Industry","document_id":"FDA-2025-N-1243-0025"},{"title":"Reference 2 - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions","document_id":"FDA-2025-N-1243-0024"},{"title":"Reference 1 - Requests for Feedback and Meetings for Medical Device Submissions The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2025-N-1243-0023"},{"title":"List of References","document_id":"FDA-2025-N-1243-0022"},{"title":"Reference 14 - Bauman JG, Wiegant J, Borst P, van Duijn P. A new method for fluorescence microscopical localization of specific DNA sequences by in situ hybridization of fluorochromelabelled RNA","document_id":"FDA-2025-N-1243-0016"},{"title":"Reference 13 - Manning JE, Hershey ND, Broker TR, Pellegrini M, Mitchell HK, Davidson N. A new method of in situ hybridization","document_id":"FDA-2025-N-1243-0015"},{"title":"Reference 12 - du Sart, D., Andy Choo, K.H. (1998). The Technique of In Situ Hybridization. In: Rapley, R., Walker, J.M. (eds) Molecular Biomethods Handbook. Springer Protocols Handbooks","document_id":"FDA-2025-N-1243-0014"},{"title":"Reference 11- Chu YH, Hardin H, Zhang R, Guo Z, Lloyd RV. In situ hybridization: Introduction to techniques, applications and pitfalls in the performance and interpretation of assays","document_id":"FDA-2025-N-1243-0013"},{"title":"Reference 10 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. National Center for Health Statistics. Vital Health Stat 73(4). 2024","document_id":"FDA-2025-N-1243-0012"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-1243","supporting_documents_count":20,"docket_id":"FDA-2025-N-1243","document_id":"FDA-2025-N-1243-0021","regulation_id_number":null,"title":"Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product","checked_regulationsdotgov_at":"2026-08-18T16:55:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53184,"subtype":null,"title":"Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product","toc_doc":"Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product","toc_subject":"Hematology and Pathology Devices","topics":["Blood","Medical devices","Packaging and containers"],"type":"Rule","volume":91}