21 CFR Part 870, Subpart D - Cardiovascular Prosthetic Devices

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There are 2 Updates appearing in the Federal Register for 21 CFR 870. View below or at eCFR (GPOAccess)

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-12-30; vol. 78 # 250 - Monday, December 30, 2013
    1. 78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective December 30, 2013.
      21 CFR Part 870

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 870 after this date.

  • 2014-01-07; vol. 79 # 4 - Tuesday, January 7, 2014
    1. 79 FR 765 - 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
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      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.
      21 CFR Part 870