Code of Federal Regulations: Containing a Codification of Documents of ...

870.2060 Transducer signal amplifier and signal conditioner.

870.2100 Cardiovascular blood flowmeter. 870.2120 Extravascular blood flow probe. 870.2300 Cardiac monitor (including cardiotachometer and rate alarm). 870.2310 Apex cardiograph (vibrocardiograph).

870.2320 Ballistocardiograph. 870.2330 Echocardiograph. 870.2340 Electrocardiograph.

870.2350 Electrocardiograph lead switching adaptor.

870.2360 Electrocardiograph electrode. 870.2370 Electrocardiograph surface electrode tester.

870.2390 Phonocardiograph. 870.2400 Vectorcardiograph.

870.2450 Medical cathode-ray tube display. 870.2600 Signal isolation system. 870.2620 Line isolation monitor.

870.2640 Portable leakage current alarm. Oscillometer.

870.2675

870.3650 Pacemaker polymeric mesh bag. 870.3670 Pacemaker charger.

870.3680 Cardiovascular permanent or tem

porary pacemaker electrode.

870.3690 Pacemaker test magnet. 870.3700 Pacemaker programmers. 870.3710 Pacemaker repair or replacement material.

Sec.

870.5200 External cardiac compressor. 870.5225 External counter-pulsating

device.

870.5300 DC-defibrillator (including paddles).

870.5325 Defibrillator tester. 870.5550 External transcutaneous cardiac

pacemaker (noninvasive).

870.5800 Compressible limb sleeve. 870.5900 Thermal regulating system. 870.5925 Automatic rotating tourniquet.

AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).

SOURCE: 45 FR 7907-7971, Feb. 5, 1980, unless otherwise noted.

Subpart A-General Provisions

§ 870.1 Scope.

(a) This part sets forth the classification of cardiovascular devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under Part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a cardiovascular device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.

[52 FR 17735, May 11, 1987]

§ 870.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an

exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class

III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

[52 FR 17735, May 11, 1987]

§ 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or

(b) The modified device operates using a different fundamental scientific technology than that in use in the device before May 28, 1976; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology.

[54 FR 25049, June 12, 1989]

Subpart B-Cardiovascular Diagnostic Devices

§ 870.1025 Arrhythmia detector and alarm. (a) Identification. An arrhythmia detector and alarm is a system that monitors the electrocardiogram and is designed to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 870.3.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]

§ 870.1100 Blood pressure alarm.

(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.