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 2015_register executive 2015-10-08 article Proposed Rules D09002ee1c7f70887 D09002ee1c7f708f6 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 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. 80 FR 60809 https://www.govinfo.gov/app/details/FR-2015-10-08/2015-25627 2015-25627 fr08oc15-8 4164-01-P Docket No. FDA-2015-N-0701 https://www.govinfo.gov/app/details/FR-2015-10-08/2015-25627 https://www.govinfo.gov/content/pkg/FR-2015-10-08/html/2015-25627.htm https://www.govinfo.gov/content/pkg/FR-2015-10-08/pdf/2015-25627.pdf Medical Devices 9 p. 60809 60817 80 FR 60809 Title 21 Part 880 21 CFR Part 880 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; Federal Register Vol. 80, Issue PRORULE 2015-25627 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-12-07 Docket No. FDA-2015-N-0701 4164-01-P 2015-25627 Proposed rule.

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.

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. Michael J. Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-6283. Medical Devices 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 , http://www.astm.org/Standards/E2187.htm http://www.astm.org/Standards/F1169.htm http://www.astm.org/Standards/F2710.htm http://www.bls.gov/oes/2012/may/oes_stru.htm http://www.cdc.gov/nchs/births.htm http://www.census.gov/manufacturing/asm/index.html http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html?redirect=/medhcpcsgeninfo/ http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 80, no. 195 Office of the Federal Register, National Archives and Records Administration 2015-10-08 continuing daily deposited born digital 300 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-10-08 P0b002ee18dad7d23 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08oc15 https://www.govinfo.gov/app/details/FR-2015-10-08 https://www.govinfo.gov/content/pkg/FR-2015-10-08/pdf/FR-2015-10-08.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-08/xml/FR-2015-10-08.xml fdlp 60795 61086 DGPO 2015-10-08 2024-06-02 FR-2015-10-08 machine generated eng FR FR-2015-10-08 80 195