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

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:

(1) The technical parameters of the device's hardware and software must be fully characterized and be accompanied by appropriate non-clinical testing:

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

(2) The device must be designed and tested for electrical safety.

(3) The labeling must include:

(i) A summary of any testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function. The summary of testing must include the following, if available: Any expected or observed adverse events and complications; any performance measurements including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) per the devices intended use; a description of the repeatability of measurements; a description of how the cut-off values for categorization of measurements were determined; and a description of the construct validity of the device.

(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305.

(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

(b) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special controls for this device are:

(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety.

(2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed.

(3) The elements of the device that contact the patient must be assessed to be biocompatible.

(4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include:

(i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen;

(ii) Warning to only use the device on normal, intact, clean, healthy skin;

(iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;

(iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and

(v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device.