Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Full Text

<html>
<head>
<title>Federal Register, Volume 91 Issue 209 (Friday, October 30, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Rules and Regulations]
[Pages 68465-68467]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22179]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2026-N-12213]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Software-Aided Adjunctive Diagnostic Device for 
Use by Physicians on Lesions Suspicious for Skin Cancer

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
software-aided adjunctive diagnostic device for use by physicians on 
lesions suspicious for skin cancer into class II (special controls). 
The special controls that apply to the device type are identified in 
this order and will be part of the codified language for classification 
of the software-aided adjunctive diagnostic device for use by 
physicians on lesions suspicious for skin cancer. We are taking this 
action because we have determined that classifying the device into 
class II will provide a reasonable assurance of the safety and 
effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices, in part by reducing 
regulatory burdens.

DATES: This order is effective October 30, 2026. The classification was 
applicable on January 12, 2024.

FOR FURTHER INFORMATION CONTACT: Rudy Andriani, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4540, Silver Spring, MD 20993-0002, 240-402-6030, 
<a href="/cdn-cgi/l/email-protection#df8daabba6f19eb1bbadb6beb1b69fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="326047564b1c735c56405b535c5b725456531c5a5a411c555d44">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the software-
aided adjunctive diagnostic device for use by physicians on lesions 
suspicious for skin cancer into class II (special controls), which we 
have determined will provide a reasonable assurance of the safety and 
effectiveness of the device. In addition, we believe this action will 
enhance patients' access to beneficial innovation, in part by reducing 
regulatory burdens by placing the device into a lower device class than 
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified into, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate device by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). 
Section 207 of the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) established the first procedure for De Novo 
classification. Section 607 of the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) modified the De Novo 
classification process by adding a second procedure. A device sponsor 
may utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a premarket 
notification (510(k)) for a device that has not previously been 
classified. After receiving an order from FDA classifying the device 
into class III under section 513(f)(1) of the FD&C Act, the person then 
requests a classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the 
FD&C Act). As a result, other device sponsors do not have to submit a 
De Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On February 2, 2023, FDA received DermaSensor Inc.'s request for De 
Novo classification of the DermaSensor device. FDA reviewed the request 
in order to classify the device under the criteria for classification 
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable

[[Page 68466]]

assurance of the safety and effectiveness of the device, but there is 
sufficient information to establish special controls that, in 
combination with the general controls, provide reasonable assurance of 
the safety and effectiveness of the device for its intended use (see 
section 513(a)(1)(B) of the FD&C Act). After review of the information 
submitted in the request, we determined that the device can be 
classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on January 12, 2024, FDA issued an order to the 
requester classifying the device into class II. In this final order, 
FDA is codifying the classification of the device by adding 21 CFR 
878.1830.\1\ We have named the generic type of device ``software-aided 
adjunctive diagnostic device for use by physicians on lesions 
suspicious for skin cancer,'' and it is identified as a prescription 
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 use by a physician not 
trained in the clinical diagnosis and management of skin cancer as an 
adjunctive second-read device following identification of a suspicious 
skin lesion. It is not for use as a standalone diagnostic and is not 
for use to confirm a clinical diagnosis.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the risks to health associated with this type of 
device and the measures required to mitigate these risks in table 1.

   Table 1--Risks to Health and Mitigation Measures for Software-Aided
Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious
                             for Skin Cancer
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
False negative results, leading to       Clinical performance testing;
 failure to treat cancer and cancer       Postmarket surveillance; Non-
 progression, or false positive           clinical performance testing;
 results, leading to unnecessary          and Labeling.
 referrals and/or medical procedures.
False results or failure to generate a   Precision testing; Human
 result due to use error or improper      factors testing; and Labeling.
 device use.
False results or failure to generate a   Non-clinical performance
 result due to device failure or          testing; Precision testing;
 malfunction.                             Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Electrical, thermal, mechanical, or      Electrical, mechanical, and
 light exposure-related injury.           thermal safety testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Interference with other devices........  Electromagnetic compatibility
                                          testing.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection and cross-contamination......  Cleaning and disinfection
                                          validation; and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness of the device. For a device 
to fall within this classification, and thus avoid automatic 
classification in class III, it would have to comply with the special 
controls named in this final order. The necessary special controls 
appear in the regulation codified by this final order.
    At the time of classification, software-aided adjunctive diagnostic 
devices for use by physicians on lesions suspicious for skin cancer are 
for prescription use only. Prescription devices are exempt from the 
requirement for adequate directions for use for the layperson under 
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 
801.5, as long as the conditions of 21 CFR 801.109 are met.
    Under the FD&C Act, submission of a premarket notification under 
section 510(k) is required to reasonably assure the safety and 
effectiveness of class II devices unless FDA determines that the device 
type should be exempt under section 510(m) of the FD&C Act. At this 
time FDA has not made this determination for software-aided adjunctive 
diagnostic devices for use by physicians on lesions suspicious for skin 
cancer. This device is therefore subject to premarket notification 
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not normally have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information in part 860, subpart D, regarding De Novo classification 
have been approved under OMB control number 0910-0844; the collections 
of information in 21 CFR part 814, subparts A through E, regarding 
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions have been approved under OMB control 
number 0910-0120; the collections of information in 21 CFR part 820 
regarding quality management system regulation have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 regarding labeling have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

[[Page 68467]]

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  878.1830 to subpart B to read as follows:


Sec.  878.1830  Software-aided adjunctive diagnostic device for use by 
physicians on lesions suspicious for skin cancer.

    (a) Identification. A software-aided adjunctive diagnostic device 
for use by physicians on lesions suspicious for skin cancer is a 
prescription 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 use by a 
physician not trained in the clinical diagnosis and management of skin 
cancer as an adjunctive second-read device following identification of 
a suspicious skin lesion. It is not 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 and postmarket surveillance acquired under anticipated 
conditions of use must demonstrate that the device performs as intended 
in the intended patient population, unless FDA determines based on the 
totality of the information provided for premarket review that data 
from postmarket surveillance is not required.
    (i) Data must demonstrate superior accuracy of device-aided users' 
diagnostic characterization of the indicated lesions compared to the 
accuracy of unaided users.
    (ii) Clinical testing must evaluate patients across a range of skin 
phototypes, risk factors, and anatomic areas that represents the 
intended use population.
    (iii) Standalone device performance testing must demonstrate the 
accuracy of the device output relative to ground truth, including the 
following:
    (A) Testing must demonstrate at least 90 percent 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 for the reported 
specificity.
    (B) Lesions must be selected by representative users and include a 
justified quantity and range of mimic lesions per diagnosis.
    (C) Justification must be provided for the determination of ground 
truth.
    (D) Testing must include a representative range of individuals with 
diverse risk factors (including age, body site, skin phototype, and 
other clinical factors), and analysis of standalone performance must 
include subgroup analysis by relevant risk factors.
    (2) 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).
    (3) Performance testing must demonstrate device precision, 
including repeatability and reproducibility of device performance, 
across operators and challenging use conditions.
    (4) Performance testing must demonstrate the electrical safety, 
mechanical safety, thermal safety, and electromagnetic compatibility of 
any electrical components of the device.
    (5) Performance testing must validate reprocessing instructions for 
reusable components of the device.
    (6) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Software verification, validation, and hazard analysis must be 
performed.
    (8) Human factors assessment must demonstrate that the device can 
be safely and correctly used by intended users.
    (9) Labeling must include:
    (i) A summary of standalone and clinical performance testing 
conducted with the device that describes 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 use population;
    (ii) A description of the patient population that was used in 
development or training of the device algorithm;
    (iii) Device limitations or subpopulations for which the device may 
not perform as expected or for whom the device has not been validated;
    (iv) Information for interpretation of the device outputs detailing 
the risks associated with misinterpretation of the device outputs;
    (v) Warnings to avoid unsafe exposure to any energy-emitting 
components of the device, e.g., excluding lesions close to the eye;
    (vi) A statement that the device is not intended for use as a 
standalone diagnostic; and
    (vii) Instructions for device maintenance and validated methods and 
instructions for reprocessing of any reusable components.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22179 Filed 10-29-26; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>