regarding general requirements concerning records, and § 820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988]

$888.5940 Cast component.

(a) Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

(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 § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994]

§888.5960 Cast removal instrument.

(a) Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996]]

$888.5980 Manual cast application and removal instrument.

(a) Identification. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.

(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 exempt from the current good manufacturing regulations in part 820 of this chapter, with the exception of § 820.180, regard

Subpart A-General Provisions

$890.1 Scope.

(a) This part sets forth the classification of physical medicine 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 physical medicine 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 17741, May 11, 1987]

§890.3 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 of 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, includiing 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 17741, May 11, 1987]

$890.9 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 with

in 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 diseases with the exception immunohistochemical devices;

of

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

[65 FR 2321, Jan. 14, 2000]

Subpart B-Physical Medicine
Diagnostic Devices

8890.1175 Electrode cable.

to

(a) Identification. An electrode cable is a device composed of strands of insulated electrical conductors laid gether around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The devices are also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]

$890.1225 Chronaximeter.

(a) Identification. A chronaximeter is a device intended for medical purposes to measure neuromuscular excitability by means of a strength-duration curve that provides a basis for diagnosis and prognosis of neurological dysfunction. (b) Classification. Class II (performance standards).

§890.1375 Diagnostic

electromyograph.

(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate pe

$890.1575 Force-measuring platform.

(a) Identification. A force-measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into analog mechanical or electrical signals. This device is used to determine ground reaction force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]

§890.1600 Intermittent pressure measurement system.

(a) Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.

$890.1925 Isokinetic testing and evaluation system.

(a) Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for : medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]

Subpart C [Reserved]

Subpart D-Physical Medicine Prosthetic Devices

$890.3025 Prosthetic and orthotic accessory.

(a) Identification. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice regulations in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

8890.3075 Cane.

(a) Identification. A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

§890.3100 Mechanical chair.

(a) Identification. A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing