{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.","action":"Proposed rule.","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/2016/03/01/2016-04411.html","cfr_references":[{"chapter":null,"citation_url":null,"part":864,"title":21}],"citation":"81 FR 10553","comment_url":null,"comments_close_on":"2016-05-31","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by May 31, 2016. Please see section IV of this document for the proposed effective date of a final rule that may issue based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0406"],"dockets":[{"supporting_documents":[{"title":"List of References Final Rule","document_id":"FDA-2016-N-0406-0021"},{"title":"Reference 1 - Blood Products Advisory Committee Meeting transcript-March 20 1998","document_id":"FDA-2016-N-0406-0020"},{"title":"Reference 2 - Blood Products Advisory Committee Meeting transcript - December  3 2014","document_id":"FDA-2016-N-0406-0019"},{"title":"Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014","document_id":"FDA-2016-N-0406-0018"},{"title":"Reference 4 - General Principles of Software Validation Final Guidance for Industry and FDA Staff","document_id":"FDA-2016-N-0406-0017"},{"title":"Reference 5 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices","document_id":"FDA-2016-N-0406-0016"},{"title":"Reference 6 - Deciding When to Submit a 510k for a Software Change to an Existing Device Guidance for Industry","document_id":"FDA-2016-N-0406-0015"},{"title":"Reference 4 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software a","document_id":"FDA-2016-N-0406-0006"},{"title":"Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","document_id":"FDA-2016-N-0406-0005"},{"title":"Reference 2 - Blood Product Advisory Committee Meeting transcript - December  3, 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","document_id":"FDA-2016-N-0406-0004"}],"agency_name":"FDA","documents":[{"comment_count":7,"comment_start_date":"2016-03-01","updated_at":"2023-02-28T16:23:38.071-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-0406-0001","allow_late_comments":null,"id":"FDA-2016-N-0406-0001","comment_end_date":"2016-06-01","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":12,"id":"FDA-2016-N-0406","title":"Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories"}],"document_number":"2016-04411","effective_on":null,"end_page":10557,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/01/2016-04411.xml","html_url":"https://www.federalregister.gov/documents/2016/03/01/2016-04411/medical-devices-hematology-and-pathology-devices-classification-of-blood-establishment-computer","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-04411?publication_date=2016-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-01/2016-04411/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1066,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-01/pdf/2016-04411.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-04411.pdf?1456753601","publication_date":"2016-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/01/2016-04411.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"List of References Final Rule","document_id":"FDA-2016-N-0406-0021"},{"title":"Reference 1 - Blood Products Advisory Committee Meeting transcript-March 20 1998","document_id":"FDA-2016-N-0406-0020"},{"title":"Reference 2 - Blood Products Advisory Committee Meeting transcript - December  3 2014","document_id":"FDA-2016-N-0406-0019"},{"title":"Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014","document_id":"FDA-2016-N-0406-0018"},{"title":"Reference 4 - General Principles of Software Validation Final Guidance for Industry and FDA Staff","document_id":"FDA-2016-N-0406-0017"},{"title":"Reference 5 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices","document_id":"FDA-2016-N-0406-0016"},{"title":"Reference 6 - Deciding When to Submit a 510k for a Software Change to an Existing Device Guidance for Industry","document_id":"FDA-2016-N-0406-0015"},{"title":"Reference 4 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software a","document_id":"FDA-2016-N-0406-0006"},{"title":"Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","document_id":"FDA-2016-N-0406-0005"},{"title":"Reference 2 - Blood Product Advisory Committee Meeting transcript - December  3, 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","document_id":"FDA-2016-N-0406-0004"}],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0406","supporting_documents_count":12,"docket_id":"FDA-2016-N-0406","document_id":"FDA-2016-N-0406-0001","regulation_id_number":null,"title":"Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","checked_regulationsdotgov_at":"2023-02-28T21:23:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10553,"subtype":null,"title":"Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","toc_doc":"Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories","toc_subject":"Medical Devices:","topics":["Blood","Medical devices","Packaging and containers"],"type":"Proposed Rule","volume":81}