§ 878.1820 Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.
(a) Identification. A software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer is a device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for prescription use by a physician trained in the clinical diagnosis and management of skin cancer (e.g., a dermatologist) as an adjunctive device to aid in the evaluation of lesions suspicious for skin cancer following identification of a suspicious skin lesion. The device is not intended for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Data obtained from premarket clinical performance validation testing, or a combination of premarket clinical performance validation testing and post-market surveillance (in accordance with paragraph (b)(2) of this section), must:
(i) Demonstrate superior accuracy of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users in the intended patient population and under anticipated conditions of use;
(ii) Include an evaluation of patients across risk factors (including age, body site, skin phototype, and other clinical factors as applicable) that represent the intended patient population under anticipated conditions of use; and
(iii) Include standalone device performance testing that demonstrates the accuracy of the device output relative to ground truth in the intended patient population and under anticipated conditions of use, including the following:
(A) Testing must demonstrate at least 90% sensitivity of the device output for lesions with high metastatic potential, or an alternative clinical consideration must be provided to justify lower sensitivity. Clinical justification must be provided to support the reported specificity.
(B) Lesions must be selected by representative users (e.g., dermatologists) and a justification must be provided for the quantity and range of mimic lesions per diagnosis.
(C) Justification must be provided to support the determination of ground truth.
(D) Testing must include a representative range of individuals with different risk factors (including age, body site, skin phototype, and other clinical factors as applicable), and analysis of standalone performance must include subgroup analysis by relevant risk factors.
(2) Data obtained from post-market surveillance must demonstrate, in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section, that the device performs in accordance with paragraph (b)(1) of this section, unless FDA determines, based on the totality of the premarket data, that data from post-market surveillance is not required to demonstrate that the device performs as intended. Such post-market surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including compatibility testing of the device software with specific signal or image acquisition hardware. Testing must include a description of compatible hardware and processes, pre-specified compatibility testing protocols, and dataset(s).
(4) Performance testing must demonstrate device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions.
(5) Performance testing must demonstrate electromagnetic compatibility, and electrical, mechanical, and thermal safety of any electrical components of the device.
(6) Performance testing must validate reprocessing instructions for reusable components of the device.
(7) Sterilization validation must be conducted for components that must be sterile. Performance testing must also demonstrate continued sterility and package integrity of components that must be sterile, as well as continued device functionality, over the identified shelf life of the device.
(8) The patient-contacting components of the device must be demonstrated to be biocompatible.
(9) Software verification, validation, and hazard analysis must be performed.
(10) A human factors assessment must demonstrate that the device can be safely used by intended users.
(11) Labeling must include:
(i) A summary of standalone and clinical performance testing conducted with the device. The summary must describe performance measures, including sensitivity and specificity, and statistical confidence intervals, as well as performance of the device for all clinically relevant subgroups within the intended patient population;
(ii) A description of the patient population that was used in development or training of the device algorithm;
(iii) Information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated;
(iv) Information needed to facilitate interpretation of all device outputs, and identification of the risks associated with misinterpretation of the device outputs;
(v) A statement that the device is not intended for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis;
(vi) User qualifications needed for safe use of the device, including a description of user training required prior to use, and a statement that the device is intended to be used by a physician trained in the clinical diagnosis and management of skin cancer (e.g., a dermatologist);
(vii) Warnings to avoid unsafe exposure to any energy-emitting components of the device (e.g., excluding use of the device on lesions close to the eye); and
(viii) Instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components.
[91 FR 14457, Mar. 25, 2026]