{"abstract":"The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission's (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.","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/2015/10/08/2015-25627.html","cfr_references":[{"chapter":null,"citation_url":null,"part":880,"title":21}],"citation":"80 FR 60809","comment_url":null,"comments_close_on":"2015-12-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by December 7, 2015. See section VII of this document for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0701"],"dockets":[{"supporting_documents":[{"title":"Ref. 4 (FR), Final Regulatory Impact Analysis, Pediatric Medical Cribs and Medical Bassinets Final Rule re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric Medi","document_id":"FDA-2015-N-0701-0026"},{"title":"Reference 3, ASTM Standard F2710-13_Standard Consumer Safety Performance Specification for Commercial Cribs re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric ","document_id":"FDA-2015-N-0701-0025"},{"title":"Reference 2 Custom Device Exemption Guidance for Industry and\nFood and Drug Administration Staff re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Cri","document_id":"FDA-2015-N-0701-0024"},{"title":"Reference 1 MedSun Newsletter #66, November 2011, Discussions with Healthcare Providers, Pediatric Hospital Cribs: MedSun Small Sample Survey Summary re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Desi","document_id":"FDA-2015-N-0701-0023"},{"title":"Reference 8, U.S. Census Bureau, 2013 Annual Survey of Manufacturers re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical ","document_id":"FDA-2015-N-0701-0010"},{"title":"Reference 7, Centers for Medicare & Medicaid Services, HCPCS 2015 Code E0300 re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of ","document_id":"FDA-2015-N-0701-0009"},{"title":"Reference 6, Occupational Employment Statistics provided by the Bureau of Statistics, May 2012 Occupational Employment Statistics re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Co","document_id":"FDA-2015-N-0701-0008"},{"title":"Reference 5, Centers for Disease Control and Prevent, National Vital Statistics System, Birth Data re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Cr","document_id":"FDA-2015-N-0701-0007"},{"title":"Reference 4, ASTM Standard E2187-09_Standard Test Method for Measuring the Ingintion Strength of Cigarettes re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric M","document_id":"FDA-2015-N-0701-0006"},{"title":"Reference 3, ASTM Standard F2710-13_Standard Consumer Safety Performance Specification for Commercial Cribs re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric M","document_id":"FDA-2015-N-0701-0005"}],"agency_name":"FDA","documents":[{"comment_count":11,"comment_start_date":"2015-10-08","updated_at":"2023-02-28T23:54:14.071-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-0701-0001","allow_late_comments":null,"id":"FDA-2015-N-0701-0001","comment_end_date":"2015-12-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":13,"id":"FDA-2015-N-0701","title":"Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet"}],"document_number":"2015-25627","effective_on":null,"end_page":60817,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/08/2015-25627.xml","html_url":"https://www.federalregister.gov/documents/2015/10/08/2015-25627/general-hospital-and-personal-use-devices-renaming-of-pediatric-hospital-bed-classification-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-25627?publication_date=2015-10-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-08/2015-25627/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1847,"last_updated":"2026-07-26 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-08/pdf/2015-25627.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-25627.pdf?1444221957","publication_date":"2015-10-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/08/2015-25627.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Ref. 4 (FR), Final Regulatory Impact Analysis, Pediatric Medical Cribs and Medical Bassinets Final Rule re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric Medi","document_id":"FDA-2015-N-0701-0026"},{"title":"Reference 3, ASTM Standard F2710-13_Standard Consumer Safety Performance Specification for Commercial Cribs re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric ","document_id":"FDA-2015-N-0701-0025"},{"title":"Reference 2 Custom Device Exemption Guidance for Industry and\nFood and Drug Administration Staff re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Cri","document_id":"FDA-2015-N-0701-0024"},{"title":"Reference 1 MedSun Newsletter #66, November 2011, Discussions with Healthcare Providers, Pediatric Hospital Cribs: MedSun Small Sample Survey Summary re General Hospital and Personal Use Devices: Renaming of Pediatric  Hospital Bed Classification and Desi","document_id":"FDA-2015-N-0701-0023"},{"title":"Reference 8, U.S. Census Bureau, 2013 Annual Survey of Manufacturers re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical ","document_id":"FDA-2015-N-0701-0010"},{"title":"Reference 7, Centers for Medicare & Medicaid Services, HCPCS 2015 Code E0300 re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of ","document_id":"FDA-2015-N-0701-0009"},{"title":"Reference 6, Occupational Employment Statistics provided by the Bureau of Statistics, May 2012 Occupational Employment Statistics re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Co","document_id":"FDA-2015-N-0701-0008"},{"title":"Reference 5, Centers for Disease Control and Prevent, National Vital Statistics System, Birth Data re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Cr","document_id":"FDA-2015-N-0701-0007"},{"title":"Reference 4, ASTM Standard E2187-09_Standard Test Method for Measuring the Ingintion Strength of Cigarettes re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric M","document_id":"FDA-2015-N-0701-0006"},{"title":"Reference 3, ASTM Standard F2710-13_Standard Consumer Safety Performance Specification for Commercial Cribs re General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric M","document_id":"FDA-2015-N-0701-0005"}],"comments_count":11,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0701","supporting_documents_count":13,"docket_id":"FDA-2015-N-0701","document_id":"FDA-2015-N-0701-0001","regulation_id_number":null,"title":"Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet","checked_regulationsdotgov_at":"2023-03-01T04:54:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60809,"subtype":null,"title":"General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet","toc_doc":"Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet","toc_subject":"General Hospital and Personal Use Devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":80}