Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 39025 

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me, the Federal 

Aviation Administration proposes to 

amend 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AWP AZ E5 Grand Canyon, AZ [Amended] 

Valle Airport, AZ 

(Lat. 35°39′02′′ N, long. 112°08′53′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.8-mile 

radius of the airport beginning at the 020° 

bearing from the airport clockwise to the 190° 

bearing from the airport, and within a 6.4- 

mile radius of the airport beginning at the 

190° bearing from the airport clockwise to the 

020° bearing from the airport. 

Issued in Des Moines, Washington, on June 

24, 2022. 

B.G. Chew, 

Acting Group Manager, Operations Support 

Group, Western Service Center. 

[FR Doc. 2022–13976 Filed 6–29–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2022–N–0794] 

General and Plastic Surgery Devices; 

Reclassification of Optical Diagnostic 

Devices for Melanoma Detection and 

Electrical Impedance Spectrometers, 

To Be Renamed Computer-Aided 

Devices Which Provide Adjunctive 

Diagnostic Information About Lesions 

Suspicious for Melanoma 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Proposed amendment; proposed 

order; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing on its own initiative to 

reclassify optical diagnostic devices for 

melanoma detection and electrical 

impedance spectrometers, both of which 

are postamendments class III devices 

(product codes OYD and ONV, 

respectively), into class II (special 

controls), subject to premarket 

notification. FDA is also proposing a 

new device classification regulation 

with the name ‘‘computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma,’’ along with special controls 

that the Agency believes are necessary 

to provide a reasonable assurance of 

safety and effectiveness for these 

devices. If finalized, this order will 

reclassify these devices from class III to 

class II and the submission of a 

premarket approval application (PMA) 

for these devices will no longer be 

required, and instead the submission of 

a premarket notification (510(k)) will be 

required. 

DATES: Submit either electronic or 

written comments on the proposed 

order by August 29, 2022. Please see 

section X of this document for the 

proposed effective date when the new 

requirements apply and for the 

proposed effective date of a final order 

based on this proposed order. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

August 29, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal Rulemaking Portal: https:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0794 for ‘‘General and Plastic 

Surgery Devices; Reclassification of 

Optical Diagnostic Devices for 

Melanoma Detection and Electrical 

Impedance Spectrometers, To Be 

Renamed Computer-Aided Devices 

Which Provide Adjunctive Diagnostic 

Information about Lesions Suspicious 

for Melanoma.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday Eastern Time, 240–402– 

7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 


jspears on DSK121TN23PROD with PROPOSALS1
39026 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 

1FDA notes that the ACTION caption for this final 

order is styled as ‘‘Proposed amendment; proposed 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: Neil 

Ogden, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4612, Silver Spring, 

MD 20993, 301–796–6397, neil.ogden@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended, 

establishes a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Section 513(a)(1) of the FD&C Act 

defines the three classes of devices. 

Class I devices are those devices for 

which the general controls of the FD&C 

Act (controls authorized by or under 

section 501, 502, 510, 516, 518, 519, or 

520 (21 U.S.C. 351, 352, 360, 360f, 360h, 

360i, or 360j) or any combination of 

such sections) are sufficient to provide 

reasonable assurance of safety and 

effectiveness; or those devices for which 

insufficient information exists to 

determine that general controls are 

sufficient to provide reasonable 

assurance of safety and effectiveness or 

to establish special controls to provide 

such assurance, but because the devices 

are not purported or represented to be 

for a use in supporting or sustaining 

human life or for a use which is of 

substantial importance in preventing 

impairment of human health, and do 

not present a potential unreasonable 

risk of illness or injury, are to be 

regulated by general controls (section 

513(a)(1)(A) of the FD&C Act). Class II 

devices are those devices for which 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

and for which there is sufficient 

information to establish special controls 

to provide such assurance, including the 

issue of performance standards, 

postmarket surveillance, patient 

registries, development and 

dissemination of guidelines, 

recommendations, and other 

appropriate actions the Agency deems 

necessary to provide such assurance 

(section 513(a)(1)(B) of the FD&C Act). 

Class III devices are those devices for 

which insufficient information exists to 

determine that general controls and 

special controls would provide a 

reasonable assurance of safety and 

effectiveness, and are purported or 

represented to be for a use in supporting 

or sustaining human life or for a use 

which is of substantial importance in 

preventing impairment of human 

health, or present a potential 

unreasonable risk of illness or injury 

(section 513(a)(1)(C) of the FD&C Act). 

Devices that were not in commercial 

distribution before May 28, 1976 

(generally referred to as 

‘‘postamendments devices’’) are 

automatically classified by section 

513(f)(1) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval, unless, and 

until: (1) FDA reclassifies the device 

into class I or II or (2) FDA issues an 

order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. The Agency 

determines whether new devices are 

substantially equivalent to predicate 

devices by means of the premarket 

notification procedures in section 510(k) 

of the FD&C Act (21 U.S.C. 360(k)) and 

part 807, subpart E, of FDA’s regulations 

(21 CFR part 807). 

A postamendments device that has 

been initially classified in class III 

under section 513(f)(1) of the FD&C Act 

may be reclassified into class I or class 

II under section 513(f)(3) of the FD&C 

Act. Section 513(f)(3) of the FD&C Act 

provides that FDA, acting by 

administrative order, can reclassify the 

device into class I or class II on its own 

initiative, or in response to a petition 

from the manufacturer or importer of 

the device. To change the classification 

of the device, the proposed new class 

must have sufficient regulatory controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

Reevaluation of the data previously 

before the Agency is an appropriate 

basis for subsequent action where the 

reevaluation is made in light of newly 

available regulatory authority (see Bell 

v. Goddard, 366 F.2d 177, 181 (7th Cir. 

1966); Ethicon, Inc. v. FDA, 762 F. 

Supp. 382, 388–391 (D.D.C. 1991)) or in 

light of changes in ‘‘medical science’’ 

(Upjohn Co. v. Finch, 422 F.2d 944, 951 

(6th Cir. 1970)). Whether data before the 

Agency are old or new, the information 

to support reclassification must be 

‘‘valid scientific evidence,’’ as defined 

in section 513(a)(3) of the FD&C Act and 

21 CFR 860.7(c)(2). (See, e.g., General 

Medical Co. v. FDA, 770 F.2d 214 (D.C. 

Cir. 1985); Contact Lens Mfrs. Assoc. v. 

FDA, 766 F.2d 592 (D.C. Cir.1985)). 

FDA relies upon ‘‘valid scientific 

evidence’’ in the classification process 

to determine the level of regulation for 

devices. To be considered in the 

reclassification process, the ‘‘valid 

scientific evidence’’ upon which the 

Agency relies must be publicly 

available. Publicly available information 

excludes trade secret and/or 

confidential commercial information, 

e.g., the contents of a pending PMA (see 

section 520(c) of the FD&C Act (21 

U.S.C. 360j(c))). Section 520(h)(4) of the 

FD&C Act provides that FDA may use, 

for reclassification of a device, certain 

information in a PMA 6 years after the 

application has been approved. 

In accordance with section 513(f)(3) of 

the FD&C Act, FDA is issuing this 

proposed order to reclassify optical 

diagnostic devices for melanoma 

detection and electrical impedance 

spectrometers, both of which are 

postamendments class III devices, into 

class II (special controls) subject to 

premarket notification, under a new 

device classification regulation with the 

name ‘‘computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma.’’ FDA believes the standard 

in section 513(a)(1)(B) of the FD&C Act 

is met as there is sufficient information 

to establish special controls, which, in 

addition to general controls, would 

provide reasonable assurance of the 

safety and effectiveness of these 

devices.1


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 39027 

order,’’ rather than ‘‘Proposed 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. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

FDA has determined that premarket 

notification is necessary to provide a 

reasonable assurance of the safety and 

effectiveness of computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma and, therefore, the Agency 

does not intend to exempt this proposed 

class II device from the requirement for 

premarket notification (510(k)) 

submission as provided under section 

510(m) of the FD&C Act. 

II. Regulatory History of the Devices 

Under section 513(f)(1) of the FD&C 

Act, optical diagnostic devices for 

melanoma detection and electrical 

impedance spectrometers are 

automatically classified into class III 

because they were not introduced or 

delivered for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, and have not been 

found substantially equivalent to a 

device placed in commercial 

distribution after May 28, 1976, which 

was subsequently classified or 

reclassified into class II or class I. 

Therefore, they are subject to PMA 

requirements under section 515 of the 

FD&C Act (21 U.S.C. 360e). 

On November 1, 2011, FDA approved 

a PMA for MELAFIND, the first optical 

diagnostic device for melanoma 

detection to obtain FDA premarket 

authorization (Refs. 1–5). MELAFIND is 

intended for use on clinically atypical 

cutaneous pigmented lesions with one 

or more clinical or historical 

characteristics of melanoma, excluding 

those with a clinical diagnosis of 

melanoma or likely melanoma. FDA 

filed the PMA for MELAFIND (P090012) 

from MELA Sciences, Inc. on June 9, 

2009. At a meeting on November 18, 

2010, the FDA General and Plastic 

Surgery Devices Panel (the ‘‘Panel’’) 

reviewed the MELAFIND PMA (Ref. 6). 

Among other things, the Panel raised 

concerns regarding the potential use of 

MELAFIND by non-dermatologists and 

untrained operators, and regarding the 

risk that negative MELAFIND readings 

could lead to false negative diagnoses 

(e.g., where no referral forward or 

biopsy is done based on a negative 

MELAFIND finding) (Ref. 7). By a vote 

of eight to seven (with one Panel 

member abstaining), the Panel voted 

that the benefits of the device for the 

proposed indications outweighed its 

risks for the proposed indications. 

FDA subsequently approved the 

device for use by dermatologists 

choosing to obtain additional 

information for a decision to biopsy 

(and not for confirming a clinical 

diagnosis of melanoma), and for use 

only on certain types of lesions—for 

example, lesions with a diameter 

between 2 mm and 22 mm, that are 

accessible by the MELAFIND imager, 

and that are sufficiently pigmented, 

among other things (Ref. 8). FDA also 

imposed certain labeling requirements 

on the device, including a requirement 

that the labeling specify that device is 

for use only by physicians trained in the 

clinical diagnosis and management of 

skin cancer (i.e., dermatologists) who 

have also successfully completed a 

training program in the appropriate use 

of the device. FDA required that the 

sponsor conduct a post-approval study. 

The study was terminated in 2016 when 

additional data were provided in 

support of the safety and effectiveness 

of the device. 

On June 28, 2017, FDA approved a 

PMA for NEVISENSE, the first electrical 

impedance spectrometer to obtain FDA 

premarket authorization. NEVISENSE is 

indicated for use on cutaneous lesions 

with one or more clinical or historical 

characteristics of melanoma, when a 

dermatologist chooses to obtain 

additional information when 

considering biopsy. It is not for use on 

clinically obvious melanoma and is to 

be used as one element of the overall 

clinical assessment. 

As of the date of issuance of this 

proposed order, fewer than 6 years have 

transpired since FDA’s approval of PMA 

Supplement 11 for MELAFIND 

(P090012 S11) and the PMA and PMA 

supplements for NEVISENSE (PMA 

P150046 and P150046 S1–S4). 

Therefore, no information from these 

documents has been used in support of 

this proposed order to reclassify optical 

diagnostic devices for melanoma 

detection and electrical impedance 

spectrometers into class II (see section 

520(h)(4) of the FD&C Act (21 U.S.C. 

360j(h)(4))). 

As of the date of issuance of this 

proposed order, there has been a single 

recall involving the MELAFIND device, 

and no recalls involving the 

NEVISENSE device. The MELAFIND 

recall was initiated by the firm in April 

2015 due to the display of probability 

and histogram data on the device’s user 

interface that was not covered by the 

device’s approval. This recall was 

classified as class II and was terminated 

in May 2016. FDA has received no 

Medical Device Reports (MDRs) 

associated with optical diagnostic 

devices for melanoma detection or 

electrical impedance spectrometers. 

As of the date of issuance of this 

proposed order, no other optical 

diagnostic devices for melanoma 

detection or electrical impedance 

spectrometers have been approved by 

FDA. 

III. Device Description 

Optical diagnostic devices for 

melanoma detection and electrical 

impedance spectrometers are 

postamendments devices classified into 

class III under section 513(f)(1) of the 

FD&C Act. An optical diagnostic device 

for melanoma detection is a prescription 

device for use in the detection of 

melanoma and high-grade lesions 

among atypical lesions in order to rule 

out melanoma, through the use of 

visible and infrared optical radiation to 

generate images of targeted atypical 

lesions. The device is a multispectral, 

non-invasive, and automated (objective) 

computer-vision system that classifies 

the image of a pigmented skin lesion 

based upon the degree of 3-dimensional 

morphological disorganization. It is 

intended for use on clinically atypical 

cutaneous pigmented lesions with one 

or more clinical or historical 

characteristics of melanoma, excluding 

those with a clinical diagnosis of 

melanoma or likely melanoma. 

An electrical impedance spectrometer 

is a prescription device used on 

cutaneous lesions with one or more 

clinical or historical characteristics of 

melanoma, when a dermatologist 

chooses to obtain additional information 

when considering biopsy. The device 

consists of a control unit and a 

disposable electrode, which is used to 

measure electrical impedance of skin 

lesions and provide an output called the 

electrical impedance spectroscopy 

score. An electrical impedance 

spectrometer is not for use on clinically 

obvious melanoma, and is to be used as 

one element of the overall clinical 

assessment. The output given by the 

device is to be used in combination with 

clinical and historical signs of 

melanoma to obtain additional 

information prior to a decision to 

biopsy. 

FDA proposes to revise 21 CFR part 

878 to create a new device classification 

regulation with the name ‘‘computerVerDate Sep<11>2014 19:53 Jun 29, 2022 Jkt 256001 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 E:\FR\FM\30JNP1.SGM 30JNP1

jspears on DSK121TN23PROD with PROPOSALS1
39028 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 

2 In accordance with section 520(h)(4) of the 

FD&C Act, FDA has not relied on information in 

PMAs and PMA supplements approved within the 

last 6 years to develop proposed special controls or 

to otherwise inform the proposed reclassification. 

aided devices which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma.’’ A computeraided device which provides adjunctive 

diagnostic information about lesions 

suspicious for melanoma is a device that 

is used to aid in the decision-making 

process for melanoma detection. The 

device is intended for prescription use 

by a physician trained in the clinical 

diagnosis and management of skin 

cancer (e.g., a dermatologist) on skin 

lesions with one or more clinical or 

historical characteristics of melanoma, 

and is based on a computer algorithm to 

analyze optical or other physical 

properties of a skin lesion. The 

algorithm returns a classification of the 

skin lesion regarding melanoma when a 

physician trained in the clinical 

diagnosis and management of skin 

cancer chooses to obtain additional 

information when considering biopsy. 

The device is not for use as a standalone diagnostic. Optical diagnostic 

devices for melanoma detection and 

electrical impedance spectrometers are 

both examples of computer-aided 

devices which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma. FDA believes 

that computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma can facilitate more accurate 

triaging and management of those 

lesions. The devices can provide 

physicians trained in the clinical 

diagnosis and management of skin 

cancer an additional source of 

adjunctive information when triaging 

patient care for melanoma. 

IV. Proposed Reclassification and 

Summary of Reasons for 

Reclassification 

In accordance with section 513(f)(3) of 

the FD&C Act and 21 CFR part 860, 

subpart C, FDA is proposing to 

reclassify optical diagnostic devices for 

melanoma detection and electrical 

impedance spectrometers from class III 

into class II, subject to premarket 

notification (510(k)) requirements. FDA 

believes that there is sufficient 

information to establish special 

controls, and that these special controls, 

together with general controls, are 

necessary to provide a reasonable 

assurance of the safety and effectiveness 

of optical diagnostic devices for 

melanoma detection and electrical 

impedance spectrometers, to be 

renamed computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma. Optical diagnostic devices 

for melanoma detection and electrical 

impedance spectrometers are 

prescription devices, and under this 

proposed order, if finalized, computeraided devices which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma will be 

prescription devices. As such, the 

devices must satisfy prescription 

labeling requirements (see § 801.109 (21 

CFR 801.109), Prescription devices). 

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 § 801.109 are met. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma, FDA has determined that 

premarket notification is necessary to 

provide a reasonable assurance of the 

safety and effectiveness of these devices. 

Therefore, the Agency does not intend 

to exempt these proposed class II 

devices from 510(k) requirements. If this 

proposed order is finalized, persons 

who intend to market a computer-aided 

device which provides adjunctive 

diagnostic information about lesions 

suspicious for melanoma will need to 

submit to FDA a 510(k) and receive 

clearance prior to marketing the device. 

FDA believes that there is sufficient 

information available to FDA through 

the MELAFIND PMA and associated 

Panel considerations of that PMA,2

published peer-reviewed literature, and 

FDA’s publicly available MDR database, 

Manufacturer and User Facility Device 

Experience (MAUDE) database, and 

Medical Device Recall database to 

establish special controls that effectively 

mitigate the risks to health identified in 

section V. Absent the special controls 

identified in this proposed order, 

general controls applicable to the device 

are insufficient to provide reasonable 

assurance of the safety and effectiveness 

of the device. 

V. Public Health Benefits and Risks to 

Health 

FDA is providing a substantive 

summary of the valid scientific evidence 

concerning the public health benefits of 

the use of computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma, and the nature (and if 

known, the incidence) of the risks of the 

devices (see further discussion of the 

special controls being proposed to 

mitigate these risks in section VII of this 

proposed order). FDA reviewed data in 

the PMA for MELAFIND (P090012) 

available to FDA under section 520(h)(4) 

of the FD&C Act, input from the 2010 

Panel on P090012, published peerreviewed literature, and postmarket 

information regarding computer-aided 

devices which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma. 

Computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma provide a benefit to the 

public health by facilitating more 

accurate triaging and management of 

those lesions. The devices can provide 

physicians trained in the clinical 

diagnosis and management of skin 

cancer an additional source of 

adjunctive information when triaging 

patient care for melanoma. 

FDA has identified the following risks 

to health associated with the use of 

computer-aided devices which provide 

adjunctive diagnostic information about 

lesions suspicious for melanoma: 

• False negative or false positive 

results—False negative results could 

result in complications such as incorrect 

or delayed diagnoses and delays in 

biopsy decisions and melanoma 

treatment, which may allow an 

undetected condition to worsen and 

potentially increase morbidity and 

mortality. False positive results may 

result in complications such as incorrect 

management of the patient, including 

unnecessary additional invasive biopsy 

procedures and more frequent 

screenings, as well as the potential 

administration of inappropriate 

treatments and/or the withholding of 

appropriate treatments, with possible 

adverse effects. 

• Use error/improper device use— 

The device could be misused to analyze 

images from an unintended patient 

population, an unintended anatomical 

site, or lesions having an unintended 

attribute, or to analyze images acquired 

with incompatible imaging hardware or 

incompatible image acquisition 

parameters, potentially resulting in the 

device not operating at its expected 

performance level. The device could 

also be misused if the user does not 

follow the appropriate reading protocol 

for using the device to assess lesions of 

interest, which may lead to lower 

accuracy. Inaccurate results may result 

in the same complications associated 


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Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 39029 

3 In this trial, direct adverse events included 

device-related adverse events, and did not include 

false negative results that may lead to delays in the 

timely diagnosis of melanoma cancer and treatment. 

4The study had two co-primary analyses: a onesided exact 95 percent confidence bound of the 

sensitivity in detecting cutaneous melanoma of >90 

percent%; and nonrandom result at the given 

sensitivity, i.e., sensitivity + specificity >1.0. 

with false negative or false positive 

results as discussed above. 

• Device failure/malfunction—Device 

failure or malfunction could result in 

the absence or delay of device output, 

or incorrect device output, which could 

lead to inaccurate patient assessment. 

Inaccurate results may result in the 

same complications associated with 

false negative or false positive results as 

discussed above. 

• Electrical, thermal, mechanical, or 

light-related injury—While in operation, 

the device may discharge electricity that 

could shock the user or patient. 

Electrical discharge or exposure to 

device-generated heat may cause 

thermal injury or discomfort. Moving 

parts may cause mechanical injury. For 

devices that utilize energy (e.g., light) to 

provide adjunctive diagnostic 

information, accidental eye exposure to 

the energy source could cause eye 

injury. 

• Interference with other devices— 

Individuals with electrically powered 

implants could experience an adverse 

interaction with the device due to 

electromagnetic interference or 

radiofrequency interference. 

• Adverse tissue reaction—A patient 

could experience skin irritation and/or 

allergic reaction associated with the use 

and operation of the device via the use 

of non-biocompatible materials in 

patient-contacting devices. 

• Infection/cross contamination—If 

components of the device that must be 

sterile are not adequately sterilized or if 

reusable components are not adequately 

reprocessed between uses, the device 

may introduce pathogenic organisms to 

patients and cause an infection. 

VI. Summary of Data Upon Which the 

Reclassification Is Based 

FDA has considered and analyzed the 

following information: (1) data in PMA 

P090012, (2) input from the 2010 Panel 

on P090012, (3) published peerreviewed literature, and (4) FDA’s 

publicly available MDR, MAUDE, and 

Medical Device Recall databases. The 

available evidence demonstrates that 

there are public health benefits derived 

from the use of computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma. In addition, the nature of the 

associated risks to health are known, 

and special controls can be established 

to sufficiently mitigate these risks. 

FDA is proposing a single generic 

device type for computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma. Although the different 

modalities included in this proposed 

order have different technological 

characteristics in certain respects (e.g., 

the use of visible and infrared optical 

radiation vs. the use of an electrode to 

measure electrical impedance), FDA 

believes that these devices have 

sufficiently similar purposes, designs, 

functions, and other features related to 

safety and effectiveness such that the 

same regulatory controls are necessary 

and sufficient to provide reasonable 

assurance of safety and effectiveness. 

FDA believes that a single generic 

device type is therefore appropriate for 

these devices. 

On June 9, 2009, FDA filed a PMA 

(P090012) from MELA Sciences, Inc. for 

the MELAFIND, an optical diagnostic 

device for melanoma detection. This 

device is to be used by physicians 

trained in the clinical diagnosis and 

management of skin cancer (i.e., 

dermatologists) and further trained in 

the appropriate use of the device, for 

use on clinically atypical cutaneous 

pigmented lesions with one or more 

clinical or historical characteristics of 

melanoma, excluding those with a 

clinical diagnosis of melanoma or likely 

melanoma. It is intended to provide 

adjunctive information to a 

dermatologist considering biopsy of a 

suspicious lesion and is not intended to 

be used to confirm a clinical diagnosis 

of melanoma. Data provided in the PMA 

supported that there is a reasonable 

assurance of safety and effectiveness of 

this device when used as indicated 

above. These data included the results 

of a pivotal clinical trial of MELAFIND, 

which met its primary safety and 

effectiveness endpoints by achieving at 

least 95 percent sensitivity at a 95 

percent confidence level to malignant 

melanoma among lesions with 

dermatological diagnoses of ‘‘Melanoma 

cannot be ruled out’’ or ‘‘Not 

melanoma’’ (the sensitivity achieved in 

the study was 98.3 percent), and by 

achieving a superior pooled specificity 

(10.6 percent) compared to the study 

dermatologists (5.5 percent) for lesions 

that were not malignant, among lesions 

with dermatological diagnoses of 

‘‘Melanoma cannot be ruled out’’ or 

‘‘Not melanoma.’’ Additionally, no 

direct adverse events (AEs) 3 were 

reported for the patients enrolled in the 

MELAFIND pivotal study. 

At an advisory committee meeting 

held on November 18, 2010, the Panel 

discussed the MELAFIND PMA. The 

Panel raised concerns regarding, among 

other things, the use of the MELAFIND 

device by non-dermatologists, and 

regarding the use of the device by 

untrained operators. The Panel, as well 

as the PMA, also identified false 

negatives as a potential risk that could 

result in delayed care, which would be 

a significant safety concern if 

unmitigated. When FDA subsequently 

approved the device, the approval was 

limited to use as an adjunct to physician 

decision making and by physicians 

trained in the clinical diagnosis and 

management of skin cancer (i.e., 

dermatologists) who have also 

successfully completed a training 

program for the device. Notably, lesions 

that were clinically suspicious for 

melanoma would not be evaluated by 

MELAFIND, and a MELAFIND negative 

reading would be only part of the 

assessment for a clinical decision to 

biopsy, and would not replace clinical 

judgement (Ref. 1). 

FDA also performed a literature 

search to evaluate data related to optical 

diagnostic devices for melanoma 

detection and electrical impedance 

spectrometers. Published data were 

found in the literature relevant to 

optical diagnostic devices for melanoma 

detection and electrical impedance 

spectrometers. 

The clinical performance of an 

electrical impedance spectrometer was 

assessed in a multicenter, prospective, 

blinded clinical trial published in 2014 

(Ref. 9). This study focused on the safety 

and effectiveness of the device for 

distinguishing benign skin lesions from 

melanoma. Eligible skin lesions in the 

study were examined with the device, 

photographed, excised, and subjected to 

histopathological evaluation. One 

thousand, nine hundred and fifty one 

patients with 2416 lesions were 

enrolled; 1943 lesions were eligible and 

evaluable for the primary efficacy end 

point,4 including 265 melanomas. The 

sensitivity of the device was measured 

to be 96.6 percent with a specificity of 

34.4 percent, meeting the pre-specified 

study co-primary endpoints of 

sensitivity ≥0.90 to detect malignant 

melanoma and non-randomness (odds 

ratio greater than 1) to aid physicians in 

melanoma assessment. A total of 36 AEs 

were observed in 28 patients (1.5 

percent), out of which only 3 AEs 

(occurring on three patients (0.2 

percent)) were defined as definitely 

related to the device. No serious AEs, 

serious adverse device effects, or 

unanticipated adverse device effects 

were observed. The study concluded 

that the electrical impedance 


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spectrometer was accurate and safe as a 

support tool for the detection of 

cutaneous melanoma by physicians 

trained in the clinical diagnosis of skin 

cancer. 

In addition, literature reviews of 

melanoma detection technologies 

conclude that optical diagnostic devices 

for melanoma detection and electrical 

impedance spectrometers are effective 

as adjunctive sources of information for 

physicians trained in the clinical 

diagnosis and management of skin 

cancer considering biopsy of lesions 

suspicious for melanoma when they 

have high sensitivity (e.g., over 90 

percent) (Refs. 10–13). These reviews 

acknowledge that the specificity of these 

devices can be relatively low, but 

conclude that the low specificity and 

low positive predictive value is 

acceptable when there is very high 

sensitivity and negative predictive value 

associated with these devices. Data cited 

in these reviews support that these 

devices generally are more sensitive 

than visual inspection of suspicious 

lesions without magnification, and that 

when they are more sensitive than 

visual inspection, the benefits of using 

these devices to provide adjunctive 

information outweigh the risks related 

to false positives resulting in 

unnecessary biopsies because the 

adjunctive information provided by the 

device can facilitate detection of 

melanoma that may otherwise go 

undetected. One review concludes that 

the use of these devices as part of the 

biopsy decision making process 

increases the overall sensitivity for 

malignant melanoma detection, which 

justifies the low specificity and high 

biopsy number due to improved 

detection of malignant melanoma (Ref. 

10). 

The totality of the literature reviewed 

indicates that false results and 

unnecessary biopsies are among the 

potential risks related to the use of 

computer-aided devices which provide 

adjunctive diagnostic information about 

lesions suspicious for melanoma (Refs. 

1–2, 9–10). The literature reviewed 

support that these risks can be 

successfully mitigated by ensuring that 

the devices are highly sensitive, 

specifying that the devices are intended 

to be used to provide adjunctive 

information for clinical decision making 

rather than for giving a conclusive 

diagnosis, and ensuring that the user 

population are physicians trained in the 

clinical diagnosis and management of 

skin cancer and that labeling includes 

information on the appropriate training 

for these physicians to use the device 

(Refs. 11–13). 

Finally, a search of FDA’s publicly 

available MDR database revealed no 

medical device reports for product 

codes OYD and ONV, the product codes 

included in this reclassification. A 

search of FDA’s publicly available recall 

database revealed no entries for devices 

under the ONV product code and a 

single entry for a device approved under 

the OYD product code, posted on May 

20, 2015. This Class II recall was 

conducted due to a software change for 

the device’s user interface that lacked 

the requisite FDA approval. This recall 

affected approximately 65 units of the 

device and was terminated on May 4, 

2016. A search of FDA’s publicly 

available MAUDE database revealed no 

entries for devices under the OYD 

product code and a single entry for a 

device approved under the ONV 

product code. A review of the single 

entry in the MAUDE database for the 

ONV product code revealed that the 

product code was misidentified in the 

report, as evidenced by the fact that the 

event date for the entry was May 14, 

2014, which was before FDA had 

approved any devices under this 

product code. 

Based on our review of the 

information described above, FDA has 

determined that special controls, in 

addition to general controls, are 

necessary to provide a reasonable 

assurance of safety and effectiveness for 

computer-aided devices which provide 

adjunctive diagnostic information about 

lesions suspicious for melanoma, and 

that sufficient information exists to 

establish such special controls. 

Therefore, FDA, on its own initiative, is 

proposing to reclassify these devices 

from class III into class II (special 

controls), and subject to premarket 

notification (510(k)) requirements. 

VII. Proposed Special Controls 

FDA believes that the following 

proposed special controls would 

mitigate each of the risks to health 

described in section V and that these 

special controls, in addition to general 

controls, would provide a reasonable 

assurance of safety and effectiveness for 

computer-aided devices which provide 

adjunctive diagnostic information about 

lesions suspicious for melanoma. 

The risk of false positive results and 

false negative results can be mitigated 

through clinical performance testing, 

which may include, for example, standalone test(s) with acceptable 

performance thresholds (e.g., sensitivity 

and specificity), side-by-side 

comparison(s), and/or a reader study, as 

applicable, as well as non-clinical 

performance testing. The clinical 

performance testing must demonstrate 

that the device improves assisted-read 

detection and/or diagnostic 

characterization of lesions suspicious 

for melanoma compared to 

characterization of lesions without the 

device in the indicated user 

population(s) when used in accordance 

with the instructions for use. The nonclinical performance testing, among 

other things, must demonstrate that the 

device performs as intended under 

anticipated conditions of use. The risk 

of false positive results and false 

negative results can be further mitigated 

by special controls that require 

information in labeling to provide 

detailed instructions for use and inform 

the user of the expected device 

performance on a dataset representative 

of the intended population. 

The risk associated with use error and 

inappropriate use of a computer-aided 

device which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma can be 

mitigated by requiring that the following 

information be included in the device 

labeling: (1) the intended patient 

population (e.g., gender, Fitzpatrick 

Skin Type); (2) anatomical site(s); (3) 

type(s) of lesions; (4) compatible 

imaging hardware; and (5) compatible 

image acquisition parameters needed for 

the device to achieve its intended use. 

This risk can be further mitigated by 

special controls that require the device 

labeling to inform intended users of 

foreseeable situations in which the 

device is likely to fail or not to operate 

at its expected performance level. The 

risk resulting from not following the 

intended reading protocol can be 

mitigated by requiring that the device 

labeling include a device description 

and information needed to facilitate the 

clinical interpretation of all device 

outputs, and by special controls 

requiring that the device labeling 

provide a description of user training 

required prior to use. This risk can be 

further mitigated by special controls 

that require a human factors assessment 

to demonstrate that intended users can 

correctly use the device according to the 

intended use following user training. 

The risk of device failure or 

malfunction can be mitigated by 

requiring non-clinical performance 

testing and software verification, 

validation, and hazard analysis, and by 

requiring that information needed to 

facilitate the clinical interpretation of all 

device outputs be included in the 

labeling (e.g., negative/positive result, 

risk score). This risk can be further 

mitigated by special controls that 

require the device labeling to inform 

intended users of foreseeable situations 

in which the device is likely to fail or 


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not to operate at its expected 

performance level. 

The risk of electrical, thermal, 

mechanical, and light-related hazards 

leading to user injury or discomfort can 

be mitigated by special controls that 

require testing that demonstrates: (1) 

electrical, mechanical, and thermal 

safety; (2) software verification, 

validation and hazard analysis; and (3) 

device labeling that includes 

instructions on appropriate usage and 

maintenance of the device. The risk of 

eye injury due to energy (e.g., light) 

exposure can be mitigated by special 

controls that require labeling that warns 

users about exclusion of lesions close to 

the eye and unsafe energy exposure to 

the eyes. 

The risk that the device may interfere 

with other devices due to 

radiofrequency or electromagnetic 

interference can be mitigated by 

requiring testing that demonstrates 

electromagnetic compatibility. 

The risk of adverse tissue reaction for 

patient-contacting devices can be 

mitigated by special controls that 

require elements of the device that may 

contact the patient to be demonstrated 

to be biocompatible and labeling that 

includes, in addition to user 

qualifications needed for safe use of the 

device, instructions for device 

maintenance and validated methods and 

instructions for reprocessing of any 

reusable components. 

The risks of infection and cross 

contamination for patient-contacting 

components can be mitigated by special 

controls that require sterilization 

validation, shelf-life testing, and 

labeling that includes validated 

methods and instructions for 

reprocessing of any reusable 

components. 

Table 1 shows how FDA believes each 

risk to health described in section V 

would be mitigated by the proposed 

special controls. 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES FOR COMPUTER-AIDED DEVICES WHICH PROVIDE ADJUNCTIVE

DIAGNOSTIC INFORMATION ABOUT LESIONS SUSPICIOUS FOR MELANOMA

Identified risk to health Mitigation measures 

False negative or false positive results .............. Clinical performance testing, non-clinical performance testing, labeling.

Use error/improper device use ........................... Human factors assessment; labeling, including a description of user training. 

Device failure/malfunction ................................... Non-clinical performance testing, labeling, software verification, validation, and hazard analysis. 

Electrical, thermal, mechanical, or light-related 

injury.

Electrical, mechanical, and thermal safety testing, labeling, software verification, validation, 

and hazard analysis. 

Interference with other devices .......................... Electromagnetic compatibility testing. 

Adverse tissue reaction ...................................... Biocompatibility evaluation, labeling. 

Infection and cross contamination ...................... Sterilization validation, shelf-life testing, labeling. 

If this proposed order is finalized, 

optical diagnostic devices for melanoma 

detection and electrical impedance 

spectrometers will be reclassified into 

class II (special controls) as computeraided devices which provide adjunctive 

diagnostic information about lesions 

suspicious for melanoma and will be 

subject to premarket notification 

requirements under section 510(k) of the 

FD&C Act. Firms submitting a 510(k) for 

such a device will be required to 

comply with the particular mitigation 

measures set forth in the special 

controls. FDA believes that adherence to 

the special controls, in addition to the 

general controls, is necessary to provide 

a reasonable assurance of safety and 

effectiveness of computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma. 

VIII. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed order contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521) is not required. This 

proposed order refers to previously 

approved FDA collections of 

information. These collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 807, subpart 

E, have been approved under OMB 

control number 0910–0120; and the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

X. Proposed Effective Date 

FDA proposes that any final order 

based on this proposal become effective 

30 days after the date of its publication 

in the Federal Register. 

XI. Codification of Orders 

Under section 513(f)(3) of the FD&C 

Act, FDA may issue final orders to 

reclassify devices. FDA will continue to 

codify classifications and 

reclassifications in the Code of Federal 

Regulations (CFR). Changes resulting 

from final orders will appear in the CFR 

as newly codified orders. Therefore, 

under section 513(f)(3) of the FD&C Act, 

in the proposed order, we are proposing 

to codify computer-aided devices which 

provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma in the new 21 CFR 878.1820, 

under which computer-aided devices 

which provide adjunctive diagnostic 

information about lesions suspicious for 

melanoma would be reclassified into 

class II. 

XII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

* 1. P090012 Summary of Safety and 

Effectiveness Data, available at: https://

www.accessdata.fda.gov/cdrh_docs/ 

pdf9/P090012B.pdf. 

2. A. Hauschild, et al. ‘‘To Excise or Not: 

Impact of MELAFIND on German 

Dermatologists’ Decisions to Biopsy 


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39032 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Proposed Rules 

Atypical Lesions.’’ Journal der 

Deutschen Dermatologischen 

Gesellschaft. 12(7):606–614. June 2014. 

3. R.R. Winkelmann, et al. ‘‘Enhancement of 

International Dermatologists’ Pigmented 

Skin Lesion Biopsy Decisions Following 

Dermoscopy with Subsequent Integration 

of Multispectral Digital Skin Lesion 

Analysis.’’ Journal of Clinical and 

Aesthetic Dermatology. 9(7):53–5. July 

2016. 

4. R. Wells, et al. ‘‘Comparison of Diagnostic 

and Management Sensitivity to 

Melanoma Between Dermatologists and 

MELAFIND: A Pilot Study.’’ Archives of 

Dermatology. 148(9):1083–4. September 

2012. 

5. L.F. di Ruffano, et al. ‘‘Computer-Assisted 

Diagnosis Techniques (Dermoscopy and 

Spectroscopy-Based) for Diagnosing Skin 

Cancer in Adults.’’ Cochrane Skin 

Cancer Diagnostic Test Accuracy Group; 

Cochrane Database System Review. 

4;12(12). December 2018. 

* 6. FDA, November 18, 2010, Meeting of the 

General and Plastic Surgery Devices 

Panel Meeting Materials (available at 

https://wayback.archive-it.org/7993/ 

20170403223449/https:/www.fda.gov/ 

AdvisoryCommittees/ 

CommitteesMeetingMaterials/

MedicalDevices/MedicalDevices

AdvisoryCommittee/GeneralandPlastic

SurgeryDevicesPanel/ucm205684.htm). 

* 7. FDA, November 18, 2010, Meeting of the 

General and Plastic Surgery Devices 

Panel, 24-Hour Summary (available at 

https://wayback.archive-it.org/7993/2017

0403223449/https://www.fda.gov/ 

downloads/AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

MedicalDevices/MedicalDevicesAdvisory

Committee/GeneralandPlastic

SurgeryDevicesPanel/UCM234481.pdf). 

* 8. P090012 Approval Order, available at 

https://www.accessdata.fda.gov/cdrh_

docs/pdf9/P090012A.pdf. 

9. J. Malvehy, et al. ‘‘Clinical Performance of 

the NEVISENSE System in Cutaneous 

Melanoma Detection: An International, 

Multicentre, Prospective and Blinded 

Clinical Trial on Efficacy and Safety.’’ 

British Journal of Dermatology. 

171(5):1099–1107. May 2014. 

10. R.P. Braun, et al. ‘‘Electrical Impedance 

Spectroscopy in Skin Cancer Diagnosis.’’ 

Dermatologic Clinics. 35(4):489–493. 

October 2017. 

11. D.N. Dorrell and L.C. Strowd. ‘‘Skin 

Cancer Detection Technology.’’ 

Dermatologic Clinics. 37(4):527–536. 

October 2019. 

12. C. Fink and H.A. Haenssle. ‘‘Non-Invasive 

Tools for the Diagnosis of Cutaneous 

Melanoma.’’ Skin Research and 

Technology, pp. 261–271, 23 (3) (2017). 

13. R.R. Winkelmann, A.S. Farberg, A.M. 

Glazer, et al. ‘‘Noninvasive Technologies 

for the Diagnosis of Cutaneous 

Melanoma.’’ Dermatologic Clinics, pp. 

453–456, 35 (4) (2017). 

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, FDA proposes that 

21 CFR part 878 be amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for part 878 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 878.1820 to subpart B to read 

as follows: 

§ 878.1820 Computer-aided devices which 

provide adjunctive diagnostic information 

about lesions suspicious for melanoma. 

(a) Identification. A computer-aided 

device which provides adjunctive 

diagnostic information about lesions 

suspicious for melanoma is a device that 

is used to aid in the decision-making 

process for melanoma detection. The 

device is intended for prescription use 

by a physician trained in the clinical 

diagnosis and management of skin 

cancer (e.g., a dermatologist) on skin 

lesions with one or more clinical or 

historical characteristics of melanoma, 

and is based on a computer algorithm to 

analyze optical or other physical 

properties of a skin lesion. The 

algorithm returns a classification of the 

skin lesion regarding melanoma when a 

physician trained in the clinical 

diagnosis and management of skin 

cancer chooses to obtain additional 

information when considering biopsy. 

The device is not for use as a standalone diagnostic. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

demonstrate that the device improves 

assisted-read detection or diagnostic 

characterization of lesions suspicious 

for melanoma compared to 

characterization of lesions without the 

device in the indicated user 

population(s) when used in accordance 

with the instructions for use. 

(2) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. Such testing must 

include testing of safety features 

intended to mitigate device specific 

hazards and must demonstrate: 

(i) Electromagnetic compatibility, and 

electrical, mechanical, and thermal 

safety. 

(ii) 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. 

(3) Sterilization validation must be 

conducted for components that must be 

sterile. 

(4) The elements of the device that 

may contact the patient must be 

demonstrated to be biocompatible. 

(5) Software verification, validation, 

and hazard analysis must be performed. 

(6) A human factors assessment must 

demonstrate that the intended user can 

correctly use the device according to the 

intended use following user training. 

(7) Labeling must include: 

(i) A description of the device and 

information needed to facilitate clinical 

interpretation of all device outputs. 

(ii) Information regarding the 

intended patient population and 

anatomical site(s), type(s) of lesions, 

compatible hardware, and compatible 

image acquisition parameters used with 

the device in order to achieve the 

intended use. 

(iii) A summary of any clinical testing 

conducted to demonstrate how the 

device functions in providing 

information about the skin lesion. The 

summary must include the following: 

(A) A description of each device 

output and clinical interpretation. 

(B) Any performance measures, 

including sensitivity and specificity. 

(C) Relevant characteristics of the 

patients studied in the clinical 

validation (including age, gender, race 

or ethnicity, disease category), inclusion 

and exclusion criteria, and a summary 

of validation results. 

(D) The expected performance of the 

device for all intended use populations. 

(iv) A statement that the device is not 

intended for use as a stand-alone 

diagnostic. 

(v) 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). 

(vi) Warnings and cautions to mitigate 

any device specific hazards, including 

the following: 

(A) Identifying foreseeable situations 

in which the device is likely to fail or 

not to operate at its expected 

performance level; and 

(B) For devices that utilize energy to 

provide adjunctive diagnostic 

information, unless available 

information demonstrates that the 

specific warnings and cautions do not 

apply, a statement warning users about 

exclusion of lesions close to the eye and 

unsafe energy exposure to the eyes. 

(vii) Instructions for device 

maintenance and validated methods and 

instructions for reprocessing of any 

reusable components. 


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1 Documents submitted to the docket by OSHA or 

stakeholders are assigned document identification 

numbers (Document ID) for easy identification and 

retrieval. The full Document ID is the docket 

number plus a unique four-digit code. 

Dated: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13954 Filed 6–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1952 

[Docket No. OSHA–2022–0008] 

RIN 1218–AD41 

Massachusetts State Plan for State and 

Local Government Employers; 

Notification of Submission; Proposal 

To Grant Initial State Plan Approval; 

Request for Public Comment and 

Opportunity To Request Public 

Hearing 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Labor. 

ACTION: Proposed rule; request for 

written comments; notification of 

opportunity to request informal public 

hearing. 

SUMMARY: The Massachusetts 

Department of Labor Standards (the 

DLS) has submitted a developmental 

State Plan for occupational safety and 

health, applicable only to State and 

local Government employment (workers 

of the State and its political 

subdivisions) (Massachusetts State 

Plan), for determination of initial 

approval under Section 18 of the 

Occupational Safety and Health Act of 

1970 (the OSH Act). In this notification, 

OSHA proposes to grant the 

Massachusetts State Plan initial 

approval based on its preliminary 

assessment that the Massachusetts State 

Plan meets, or will meet within three 

years, OSHA’s State Plan approval 

criteria, and that Massachusetts has 

provided adequate assurances that it 

will be at least as effective as Federal 

OSHA in protecting the safety and 

health of Massachusetts state and local 

government workers. OSHA proposes to 

fund initial approval of the 

Massachusetts State Plan from the State 

Plan funding available in the 

Department of Labor’s Fiscal Year 2022 

budget. 

DATES: 

Written Comments: Comments and 

requests for a hearing must be submitted 

by August 1, 2022. 

Informal public hearing: Any 

interested person may request an 

informal hearing concerning the initial 

approval of the State Plan. OSHA will 

hold such a hearing if the Assistant 

Secretary of Labor for Occupational 

Safety and Health (Assistant Secretary) 

finds that substantial objections have 

been filed. After the close of the 

comment period, the Assistant Secretary 

will review all comments submitted; 

will review all hearing requests; and 

will schedule an informal hearing if a 

hearing is required to resolve substantial 

issues. 

Publication in Massachusetts: No later 

than 5 days following the date of 

publication of this notification in the 

Federal Register, Massachusetts shall 

publish, or cause to be published, 

reasonable notice within the State 

containing the same information 

contained herein. 

ADDRESSES: Written comments: You may 

submit written comments and requests 

for an informal hearing electronically at 

www.regulations.gov, which is the 

Federal e-Rulemaking Portal. Follow the 

online instructions for making 

electronic submissions. 

Instructions. All submissions must 

include the agency’s name and the 

docket number for this rulemaking 

(Docket No. OSHA–2021–0008).1 All 

comments, including any personal 

information you provide, are placed in 

the public docket without change and 

may be made available online at 

www.regulations.gov. Therefore, OSHA 

cautions commenters about submitting 

information they do not want made 

available to the public or submitting 

materials that contain personal 

information (either about themselves or 

others), such as Social Security 

Numbers and birthdates. Submissions 

must clearly identify the issues 

addressed and the positions taken. 

Docket: To read or download 

comments or other material in the 

docket, go to Docket No. OSHA–2022– 

0008 at www.regulations.gov. All 

comments and submissions are listed in 

the www.regulations.gov index; 

however, some information (e.g., 

copyrighted material) is not publicly 

available to read or download through 

that website. All comments and 

submissions, including copyrighted 

material, are available for inspection 

through the OSHA Docket Office. 

Contact the OSHA Docket Office at (202) 

693–2350 (TTY (877)889–5627) for 

assistance in locating docket 

submissions. 

FOR FURTHER INFORMATION CONTACT: 

For press inquiries: Contact Frank 

Meilinger, Director, OSHA Office of 

Communications, U.S. Department of 

Labor; telephone: (202) 693–1999; 

email: meilinger.francis2@dol.gov. 

For general and technical 

information: Contact Douglas J. 

Kalinowski, Director, OSHA Directorate 

of Cooperative and State Programs, U.S. 

Department of Labor; telephone: (202) 

693–2200; email: kalinowski.doug@

dol.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 18 of the OSH Act, 29 U.S.C. 

667, provides that a State which desires 

to assume responsibility for the 

development and enforcement of 

standards relating to any occupational 

safety and health issue with respect to 

a Federal standard which has been 

promulgated may submit a State Plan to 

the Assistant Secretary of Labor for 

Occupational Safety and Health 

(Assistant Secretary) documenting the 

proposed program in detail. State and 

local government employers are 

excluded from Federal OSHA coverage 

under the Act (29 U.S.C. 652(5)). 

However, a State may submit a State 

Plan for the development and 

enforcement of occupational safety and 

health standards applicable only to 

employees of the State and its political 

subdivisions (State and local 

Government employees) (29 CFR 

1956.1). The Assistant Secretary will 

approve a State Plan for State and local 

Government employees if the Plan 

provides for the development and 

enforcement of standards relating to 

hazards in employment covered by the 

Plan which are or will be at least as 

effective in providing safe and healthful 

employment and places of employment 

as standards promulgated and enforced 

under Section 6 of the Act, giving due 

consideration to differences between 

State and local Government and private 

sector employment (29 U.S.C. 667(c); 29 

CFR 1956.2(a)). In making this 

determination, the Assistant Secretary 

will measure the State Plan against the 

criteria and indices of effectiveness set 

forth in 29 CFR part 1956.10 and 

1956.11 (29 CFR 1956.2(a)). A State Plan 

for an occupational safety and health 

program for State and local Government 

employees may be approved although it 

does not yet fully meet this criteria, if 

it includes satisfactory assurances by 

the State that it will take the necessary 

steps to bring the program into 

conformity with these criteria within 

the 3-year period immediately following 

the commencement of the State Plan’s 

operation (29 CFR 1956.2(b)(1)). In such 


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