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tion 515 of the act before commercial distribution.

(52 FR 17734, May 11, 1987)

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 a 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 sec

8868.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II 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 the intended use of a legally marketed device in that generic type of device; 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;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; 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 deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic dis

with the exception of immunohistochemical devices;

eases

as

a

or

(2) For use in screening or diagnosis tient's sensitivity to pain after adminof familial or acquired genetic dis- istration of an anesthetic agent. orders, including inborn errors of me- (b) Classification. Class II (performtabolism;

ance standards). (3) For measuring an analyte that serves surrogate marker for

$ 868.1075 Argon gas analyzer. screening, diagnosis, monitoring (a) Identification. An argon gas analife-threatening diseases such as ac- lyzer is a device intended to measure quired immune deficiency syndrome the concentration of argon in a gas (AIDS), chronic or active hepatitis, tu- mixture to aid in determining the paberculosis, or myocardial infarction or tient's ventilatory status. The device to monitor therapy;

may use techniques such as mass spec(4) For assessing the risk of cardio- trometry or thermal conductivity. vascular diseases;

(b) Classification. Class II (perform(5) For use in diabetes management;

ance standards). (6) For identifying or inferring the identity of a microorganism directly

8868.1100 Arterial blood sampling kit. from clinical material;

(a) Identification. An arterial blood (7) For detection of antibodies to sampling kit is a device, in kit form, microorganisms other than

used to obtain arterial blood samples immunoglobulin G (IgG) or IgG assays

from a patient for blood gas determinawhen the results are not qualitative, or

tions. The kit may include a syringe, are used to determine immunity, or the

needle, cork, and heparin. assay is intended for use in matrices

(b) Classification. Class I. The device other than serum or plasma;

is exempt from the premarket notifica(8) For noninvasive testing as defined

tion procedures in subpart E of part 807 in $ 812.3(k) of this chapter; and

of this chapter. (9) For near patient testing (point of (47 FR 31142, July 16, 1982, as amended at 61 care).

FR 1119, Jan. 16, 1996) [65 FR 2313, Jan. 14, 2000)

$868.1120 Indwelling

blood

oxyhemoglobin concentration anaSubpart B-Diagnostic Devices lyzer.

(a) Identification. An indwelling blood $868.1030 Manual algesimeter.

oxyhemoglobin concentration analyzer (a) Identification. A manual algesim

is a photoelectric device used to measeter is a mechanical device intended to

ure, in vivo, the oxygen-carrying cadetermine a patient's sensitivity to

pacity of hemoglobin in blood to aid in pain after administration of an anes

determining the patient's physiological thetic agent, e.g., by pricking with a

status. sharp point.

(b) Classification. Class III (premarket (b) Classification. Class I. The device

approval). is exempt from the premarket notifica

(c) Date PMA or notice of completion of tion procedures in subpart E of part 807

a PDP is required. No effective date has of this chapter. The device is also ex

been established of the requirement for empt from the current good manufac

premarket approval. See 8868.3. turing practice regulations in part 820 (47 FR 31142, July 16, 1982, as amended at 52 of this chapter, with the exception of FR 17735, May 11, 1987; 52 FR 22577, June 12, $820.180, with respect to general re- 1987) quirements concerning records, and 8820.198, with respect to complaint

$ 868.1150 Indwelling blood carbon di.

oxide partial pressure (Pco2) anafiles.

lyzer. (54 FR 25048, June 12, 1989)

(a) Identification. An indwelling blood

carbon dioxide partial pressure Pco2 8868.1040 Powered algesimeter.

analyzer is a device that consists of a (a) Identification. A powered algesim- catheter-tip Pco2 transducer (e.g., Pco2 eter is a device using electrical stimu- electrode) and that is used to measure, lation intended to determine a pa- in vivo, the partial pressure of carbon dioxide in blood to aid in determining termining the patient's ventilatory, the patient's circulatory, ventilatory, circulatory, and metabolic status. The and metabolic status.

device may use techniques such as (b) Classification. Class III (premarket chemical titration, absorption of infraapproval).

red radiation, gas chromatography, or (c) Date PMA or notice of completion of mass spectrometry. a PDP is required. No effective date has (b) Classification. Class II (performbeen established of the requirement for ance standards). premarket approval. See $ 868.3.

8868.1430 Carbon monoxide gas ana[47 FR 31142, July 16, 1982; 47 FR 40410, Sept.

lyzer. 14, 1982, as amended at 52 FR 17735, May 11, 1987]

(a) Identification. A carbon monoxide

gas analyzer is a device intended to $ 868.1170 Indwelling blood hydrogen

measure the concentration of carbon ion concentration (pH) analyzer.

monoxide in a gas mixture to aid in de(a) Identification. An indwelling blood termining the patient's ventilatory hydrogen ion concentration (pH) ana- status. The device may use techniques lyzer is a device that consists of a cath- such as infrared absorption or gas chroeter-tip pH electrode and that is used

matography. to measure, in vivo, the hydrogen ion (b) Classification. Class II (performconcentration (pH) in blood to aid in ance standards). determining the patient's acid-base balance.

$868.1500 Enflurane gas analyzer. (b) Classification. Class III (premarket

(a) Identification. An enflurane gas approval).

analyzer is a device intended to meas(c) Date PMA or notice of completion of

ure the concentration of enflurane ana PDP is required. No effective date has

esthetic in a gas mixture. been established of the requirement for

(b) Classification. Class II (performpremarket approval. See $ 868.3.

ance standards). (47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)

8 868.1575 Gas collection vessel. $868.1200 Indwelling, blood

(a) Identification. A gas collection oxygen

vessel is a container-like device inpartial pressure (Poz) analyzer.

tended to collect a patient's exhaled (a) Identification. An indwelling blood

gases for subsequent analysis. It does oxygen partial pressure (Po2) analyzer

not include a sampling pump. is a device that consists of a catheter

(b) Classification. Class I. The device tip Poz transducer (e.g., Po2 electrode)

is exempt from the premarket notificaand that is used to measure, in vivo,

tion procedures in subpart E of part 807 the partial pressure of oxygen in blood

of this chapter. to aid in determining the patient's circulatory, ventilatory, and metabolic (47 FR 31142, July 16, 1982, as amended at 61 status.

FR 1119, Jan. 16, 1996) (b) Classification. Class III (premarket

8868.1620 Halothane gas analyzer. approval).

(c) Date PMA or notice of completion of (a) Identification. A halothane gas ana PDP is required. No effective date has alyzer is a device intended to measure been established of the requirement for the concentration of halothane anespremarket approval. See 8868.3.

thetic in a gas mixture. The device

may use techniques such as mass spec[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11,

trometry or absorption of infrared or 1987)

ultraviolet radiation.

(b) Classification. Class II (perform$868.1400 Carbon dioxide gas

ance standards). lyzer. (a) Identification. A carbon dioxide

8868.1640 Helium gas analyzer. gas analyzer is a device intended to (a) Identification. A helium gas anameasure the concentration of carbon lyzer is a device intended to measure dioxide in a gas mixture to aid in de- the concentration of helium in a gas

ana

$868.1750 Pressure plethysmograph.

(a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

(b) Classification. Class II (performance standards).

mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

(b) Classification. Class II (performance standards). $868.1670 Neon gas analyzer.

(a) Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

(b) Classification. Class II (performance standards). $868.1690 Nitrogen gas analyzer.

(a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

(b) Classification. Class II (performance standards). $868.1700 Nitrous oxide gas analyzer.

(a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

(b) Classification. Class II (performance standards).

$ 868.1760 Volume plethysmograph.

(a) Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

(b) Classification. Class II (performance standards).

8868.1780 Inspiratory airway pressure

meter. (a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

(b) Classification. Class II (performance standards).

$ 868.1800 Rhinoanemometer.

(a) Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.

(b) Classification. Class II (performance standards).

$868.1840 Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

(b) Classification. Class II (performance standards).

8868.1720 Oxygen gas analyzer.

(a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

(b) Classification. Class II (performance standards). $ 868.1730 Oxygen uptake computer.

(a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

(b) Classification. Class II (performance standards).

8868.1850 Monitoring spirometer.

(a) Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

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8 868.1890 Predictive pulmonary-func

tion value calculator. (a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

(b) Classification. Class II (performance standards).

$ 868.1900 Diagnostic pulmonary-func

tion interpretation calculator. (a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

(b) Classification. Class II (performance standards).

$ 868.1965 Switching valve (ploss).

(a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of

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