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 2014_register executive 2015-10-22 article Proposed Rules D09002ee1c7fa9600 D09002ee1c7fa96d6 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 proposed administrative order to reclassify nonroller-type cardiopulmonary bypass blood pump devices, when used for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls) and subject to premarket notification based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for nonroller-type cardiopulmonary bypass blood pump devices for temporary ventricular support. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements when used for temporary ventricular support. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements. 79 FR 765 https://www.govinfo.gov/app/details/FR-2014-01-07/2014-00027 2014-00027 fr07ja14-4 4160-01-P Docket No. FDA-2013-N-1518 https://www.govinfo.gov/app/details/FR-2014-01-07/2014-00027 https://www.govinfo.gov/content/pkg/FR-2014-01-07/html/2014-00027.htm https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/2014-00027.pdf Medical Devices Cardiovascular Devices 9 p. 765 773 79 FR 765 Title 21 Part 870 21 CFR Part 870 Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support; Federal Register Vol. 79, Issue PRORULE 2014-00027 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-04-07 Docket No. FDA-2013-N-1518 4160-01-P 2014-00027 Proposed order.

The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify nonroller-type cardiopulmonary bypass blood pump devices, when used for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls) and subject to premarket notification based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for nonroller-type cardiopulmonary bypass blood pump devices for temporary ventricular support. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements when used for temporary ventricular support. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.

Submit either electronic or written comments on this proposed order by April 7, 2014. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market nonroller-type cardiopulmonary bypass blood pump devices for temporary ventricular support will need to file a PMA or a notice of completion of a PDP within 90 days of the effective date of the final order. See section XVII of this document for the proposed effective date of any final order based on this proposed order. Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, angela.krueger@fda.hhs.gov. Medical Devices Cardiovascular Devices Cardiovascular Devices: Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; etc. , angela.krueger@fda.hhs.gov http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm300073.htm http://www.regulations.gov Vol. 79, no. 4 Office of the Federal Register, National Archives and Records Administration 2014-01-07 continuing daily deposited born digital 563 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-01-07 P0b002ee18dc8c74f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07ja14 https://www.govinfo.gov/app/details/FR-2014-01-07 https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/FR-2014-01-07.pdf https://www.govinfo.gov/content/pkg/FR-2014-01-07/xml/FR-2014-01-07.xml fdlp 749 893 DGPO 2015-10-22 2024-06-03 FR-2014-01-07 machine generated eng FR FR-2014-01-07 79 4