21 CFR 868, Subpart F - Therapeutic Devices
- § 868.5090 — Emergency airway needle.
- § 868.5100 — Nasopharyngeal airway.
- § 868.5110 — Oropharyngeal airway.
- § 868.5115 — Device to relieve acute upper airway obstruction.
- § 868.5120 — Anesthesia conduction catheter.
- § 868.5130 — Anesthesia conduction filter.
- § 868.5140 — Anesthesia conduction kit.
- § 868.5150 — Anesthesia conduction needle.
- § 868.5160 — Gas machine for anesthesia or analgesia.
- § 868.5165 — Nitric oxide administration apparatus.
- § 868.5170 — Laryngotracheal topical anesthesia applicator.
- § 868.5180 — Rocking bed.
- § 868.5220 — Blow bottle.
- § 868.5240 — Anesthesia breathing circuit.
- § 868.5250 — Breathing circuit circulator.
- § 868.5260 — Breathing circuit bacterial filter.
- § 868.5270 — Breathing system heater.
- § 868.5280 — Breathing tube support.
- § 868.5300 — Carbon dioxide absorbent.
- § 868.5310 — Carbon dioxide absorber.
- § 868.5320 — Reservoir bag.
- § 868.5330 — Breathing gas mixer.
- § 868.5340 — Nasal oxygen cannula.
- § 868.5350 — Nasal oxygen catheter.
- § 868.5365 — Posture chair for cardiac or pulmonary treatment.
- § 868.5375 — Heat and moisture condenser (artificial nose).
- § 868.5400 — Electroanesthesia apparatus.
- § 868.5420 — Ether hook.
- § 868.5430 — Gas-scavenging apparatus.
- § 868.5440 — Portable oxygen generator.
- § 868.5450 — Respiratory gas humidifier.
- § 868.5460 — Therapeutic humidifier for home use.
- § 868.5470 — Hyperbaric chamber.
- § 868.5530 — Flexible laryngoscope.
- § 868.5540 — Rigid laryngoscope.
- § 868.5550 — Anesthetic gas mask.
- § 868.5560 — Gas mask head strap.
- § 868.5570 — Nonrebreathing mask.
- § 868.5580 — Oxygen mask.
- § 868.5590 — Scavenging mask.
- § 868.5600 — Venturi mask.
- § 868.5610 — Membrane lung for long-term pulmonary support.
- § 868.5620 — Breathing mouthpiece.
- § 868.5630 — Nebulizer.
- § 868.5640 — Medicinal nonventilatory nebulizer (atomizer).
- § 868.5650 — Esophageal obturator.
- § 868.5655 — Portable liquid oxygen unit.
- § 868.5665 — Powered percussor.
- § 868.5675 — Rebreathing device.
- § 868.5690 — Incentive spirometer.
- § 868.5700 — Nonpowered oxygen tent.
- § 868.5710 — Electrically powered oxygen tent.
- § 868.5720 — Bronchial tube.
- § 868.5730 — Tracheal tube.
- § 868.5740 — Tracheal/bronchial differential ventilation tube.
- § 868.5750 — Inflatable tracheal tube cuff.
- § 868.5760 — Cuff spreader.
- § 868.5770 — Tracheal tube fixation device.
- § 868.5780 — Tube introduction forceps.
- § 868.5790 — Tracheal tube stylet.
- § 868.5795 — Tracheal tube cleaning brush.
- § 868.5800 — Tracheostomy tube and tube cuff.
- § 868.5810 — Airway connector.
- § 868.5820 — Dental protector.
- § 868.5830 — Autotransfusion apparatus.
- § 868.5860 — Pressure tubing and accessories.
- § 868.5870 — Nonrebreathing valve.
- § 868.5880 — Anesthetic vaporizer.
- § 868.5895 — Continuous ventilator.
- § 868.5905 — Noncontinuous ventilator (IPPB).
- § 868.5915 — Manual emergency ventilator.
- § 868.5925 — Powered emergency ventilator.
- § 868.5935 — External negative pressure ventilator.
- § 868.5955 — Intermittent mandatory ventilation attachment.
- § 868.5965 — Positive end expiratory pressure breathing attachment.
- § 868.5975 — Ventilator tubing.
- § 868.5995 — Tee drain (water trap).
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.
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.
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 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 868 after this date.
GPO FDSys XML | Text 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 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.
GPO FDSys XML | Text 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 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.