21 CFR 870, Subpart B - Cardiovascular Diagnostic Devices

There are 4 Updates appearing in the Federal Register for 21 CFR 870. Select the tab below to view, or View eCFR (GPOAccess)

prev | next

Title 21 published on 2012-04-01

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.

2013-03-26; vol. 78 # 58 - Tuesday, March 26, 2013

78 FR 18233 - Medical Devices; Technical Amendment

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06826
RIN
Docket No.	FDA-2013-N-0011

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendment.

This rule is effective March 26, 2013.

21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892

Summary

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

2012-07-06; vol. 77 # 130 - Friday, July 6, 2012

77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-16486
RIN
Docket No.	FDA-2011-N-0505

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective October 4, 2012.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.

2012-06-22; vol. 77 # 121 - Friday, June 22, 2012

77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-15258
RIN
Docket No.	FDA-2011-N-0526

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective September 20, 2012.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-15244
RIN
Docket No.	FDA-2011-N-0522

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective September 20, 2012.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

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

USC : Title 21 - FOOD AND DRUGS

§ 360c - Classification of devices intended for human use

§ 360j - General provisions respecting control of devices intended for human use

Title 21 published on 2012-04-01

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

2013-03-26; vol. 78 # 58 - Tuesday, March 26, 2013

78 FR 18233 - Medical Devices; Technical Amendment

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06826
RIN
Docket No.	FDA-2013-N-0011

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendment.

This rule is effective March 26, 2013.

21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892

Summary

2013-03-25; vol. 78 # 57 - Monday, March 25, 2013

78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06723
RIN
Docket No.	FDA-2013-N-0234

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed order.

Submit either electronic or written comments by June 24, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the device will need to submit a PMA within 90 days of the publication date of the final order. Please see section III for more information about submitting a PMA. Please also see section IX for the proposed effective date of any final order that may publish based on this proposal.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). 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 this device to meet the statute's premarket approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the automated external defibrillator based on new information. This action implements certain statutory requirements.

2013-01-08; vol. 78 # 5 - Tuesday, January 8, 2013

78 FR 1159 - Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-00086
RIN
Docket No.	FDA-2012-N-1174

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed order.

Submit either electronic or written comments on this proposed order by April 8, 2013. See section XI of this document for the proposed effective date of a final order based on this proposed order.

21 CFR Parts 868 and 870

Summary

On its own initiative, based on new information, the Food and Drug Administration (FDA) is proposing to reclassify membrane lung devices for long-term pulmonary support, a preamendments class III device, into class II (special controls) for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because circuit components used with the oxygenator are to be subject to the same regulatory controls, all of the device components used in an ECMO procedure are being considered in the scope of this proposed order, and the title and identification of the regulation will be revised accordingly to include extracorporeal circuit and accessories for long-term pulmonary/cardiac support.

78 FR 1163 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-00085
RIN
Docket No.	FDA-2012-N-1173

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed order.

Submit either electronic or written comments on this proposed order by April 8, 2013. See section XII of this document for the proposed effective date of a final order based on this proposed order.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended.

2012-07-06; vol. 77 # 130 - Friday, July 6, 2012

77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-16486
RIN
Docket No.	FDA-2011-N-0505

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective October 4, 2012.

21 CFR Part 870

Summary

2012-06-22; vol. 77 # 121 - Friday, June 22, 2012

77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-15258
RIN
Docket No.	FDA-2011-N-0526

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective September 20, 2012.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-15244
RIN
Docket No.	FDA-2011-N-0522

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective September 20, 2012.

21 CFR Part 870

Summary

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

21 CFR 870, Subpart B - Cardiovascular Diagnostic Devices

CFR Toolbox

Law about... Articles from Wex

Find a Lawyer

Get Involved