Document ID: FDA-2018-N-1440-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Medical Device Classification Regulations To Conform  to Medical Software Provisions in the  21st Century Cures Act
Posted Date: 2021-04-19T04:00Z

[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Rules and Regulations]
[Pages 20278-20284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07860]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 880, 884 and 892

[Docket No. FDA-2018-N-1440]
RIN 0910-AH67

Medical Devices; Medical Device Classification Regulations To 
Conform to Medical Software Provisions in the 21st Century Cures Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration (FDA, Agency, or we) is 
amending certain classification regulations to reflect changes to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st 
Century Cures Act (the Cures Act). The Cures Act amended the definition 
of a device in the FD&C Act to exclude certain software functions. FDA 
is taking this action so that its regulations conform to the medical 
software provisions in the Cures Act.

DATES: This rule is effective on April 19, 2021.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5528, Silver Spring, MD 20993, 301-796-5528, email: 
Bakul.Patel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
II. Table of Abbreviations and Acronyms Commonly Used in This 
Document
III. Background
IV. Legal Authority
V. Description of the Final Rule
    A. Scope
    B. Calculator/Data Processing Module for Clinical Use
    C. Continuous Glucose Monitor Secondary Display
    D. Automated Indirect Immunofluorescence Microscope and 
Software-Assisted System
    E. Medical Device Data Systems
    F. Home Uterine Activity Monitor
    G. Medical Image Storage Device
    H. Medical Image Communications Device
    I. Picture Archiving and Communications System
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Final Rule

    On December 13, 2016, the Cures Act was enacted (Pub. L. 114-255). 
The Cures Act amended the FD&C Act to include descriptions of software 
functions that are excluded from the definition of device in the FD&C 
Act. The Cures Act amended the FD&C Act to state that the term device 
does not include the software functions excluded pursuant to section 
520(o)(1) of the FD&C Act.
    Among the software functions excluded from the definition of device 
by this provision, most relevant to this rule are the software 
functions intended to transfer, store, convert formats, or display 
clinical laboratory test or other device data, results, and findings 
and that do not interpret or analyze such clinical laboratory test or 
other device data, results, and findings. Because the provision only 
excludes certain software functions from the device definition, the 
regulatory status of device hardware remains unchanged. With this final 
rule, FDA is amending the ``identification'' description of eight 
classification regulations so that the regulations no longer include 
software functions that the Cures Act excluded from the device 
definition in the FD&C Act. In other words, in this action, FDA is 
amending eight classification regulations so that the regulations 
conform to the medical software provisions of the Cures Act and reflect 
FDA's current statutory authority.

B. Summary of the Major Provisions of the Final Rule

    This rule updates eight classification regulations by amending 
these regulations to exclude software functions that no longer fall 
within the device definition under 201(h) of the FD&C Act. 
Specifically, FDA is amending the following classification regulations:
     Amend the calculator/data processing module for clinical 
use ``identification'' description to remove non-device software 
functions that maintain and retrieve laboratory data;
     amend the continuous glucose monitor (CGM) secondary 
display ``identification'' description to remove receive and display 
software functions, and amend the title of the CGM secondary display 
regulation to

[[Page 20279]]

``Continuous Glucose Monitor (CGM) Secondary Alarm System;''
     amend the automated indirect immunofluorescence microscope 
and software-assisted system device ``identification'' description by 
replacing the first use of the word ``software'' with ``device'' 
because both hardware and software functions that use fluorescent 
signal acquisition and processing software, data storage, and 
transferring mechanisms, or assay specific algorithms to interpret or 
analyze results, are devices;
     amend the medical device data systems (MDDS) 
``identification'' description to remove non-device software functions 
intended for transferring, storing, converting formats, or displaying 
clinical laboratory test or other device data and results;
     amend the home uterine activity monitor (HUAM) 
``identification'' description to remove non-device software functions 
intended for transmitting, receiving, and displaying data;
     amend medical image storage device ``identification'' 
description to remove non-device software functions intended for 
storing and retrieving so that a medical image storage device is a 
hardware device that provides electronic storage and retrieval 
functions for medical images;
     amend medical image communications device 
``identification'' description to include software functions intended 
for medical image processing and manipulation; and
     amend picture archiving and communications system 
``identification'' description to remove non-device software functions 
intended for storing and displaying medical images, revise the 
``identification'' description to clarify that the regulation includes 
software and hardware functions intended for medical image management 
and processing, and revise the title of the classification regulation 
to ``Medical Image Management and Processing System.''
    This final rule does not change the classification of the device 
types for which FDA is amending the title and/or identification 
statements. This rule will ensure that the specific classification 
regulations conform to changes the Cures Act made to the FD&C Act and 
reflect current FDA statutory authority.

C. Legal Authority

    This final rule is being issued under sections 201(h), 520(o), and 
701 of the FD&C Act (21 U.S.C. 321, 360j, and 371) and the device and 
general administrative provisions of the FD&C Act sections 501, 510, 
513, 515, 520, 522, and 701 (21 U.S.C. 351, 360, 360c, 360e, 360j, 
360l, and 371).

II. Table of Abbreviations and Acronyms Commonly Used in This Document

----------------------------------------------------------------------------------------------------------------
       Abbreviation or acronym                                       What it means
----------------------------------------------------------------------------------------------------------------
510(k)..............................  Premarket Notification.
APA.................................  Administrative Procedure Act.
CFR.................................  Code of Federal Regulations.
CGM.................................  Continuous Glucose Monitor.
Cures Act...........................  21st Century Cures Act.
E.O.................................  Executive Order.
FDA or the Agency...................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic Act.
HUAM................................  Home Uterine Activity Monitor.
IMACS...............................  Image Management and Communications Systems.
MDDS................................  Medical Device Data System.
PACS................................  Picture Archiving and Communications System.
U.S.C...............................  United States Code.
----------------------------------------------------------------------------------------------------------------

III. Background

    On December 13, 2016, the Cures Act was enacted. The Cures Act 
amended, among other things, FDA's authority to regulate medical 
software, including certain clinical decision support software. The 
provision of the Cures Act entitled ``Clarifying Medical Software 
Regulation,'' amended section 520 of the FD&C Act by adding subsection 
(o), which describes specific software functions that are excluded from 
the definition of device in the FD&C Act (section 201(h) of FD&C Act).
    Section 520(o)(1) of the FD&C Act excludes from the definition of 
device software functions that are intended for:
    1. Administrative support of a healthcare facility (section 
520(o)(1)(A));
    2. Maintaining or encouraging a healthy lifestyle and unrelated to 
the diagnosis, cure, mitigation, prevention, or treatment of a disease 
or condition (section 520(o)(1)(B));
    3. Serving as electronic patient records, including patient-
provided information, to the extent that such records are intended to 
transfer, store, convert formats, or display the equivalent of a paper 
medical chart, so long as such records were created, stored, 
transferred, or reviewed by healthcare professionals or by individuals 
working under supervision of such professionals; such records are part 
of health information technology that is certified under section 
3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-11(c)(5)); 
and such function is not intended to interpret or analyze patient 
records, including medical image data, for the purpose of diagnosis, 
cure, mitigation, prevention, or treatment of a disease or condition 
(section 520(o)(1)(C)); or
    4. Transferring, storing, converting formats, or displaying 
clinical laboratory test or other device data and results, findings by 
a healthcare professional with respect to such data and results, unless 
such function is intended to interpret or analyze clinical laboratory 
test or other device data, results, or findings (section 520(o)(1)(D)); 
or
    5. Unless the function is intended to acquire, process, or analyze 
a medical image or a signal from an in vitro diagnostic device or a 
pattern or signal from a signal acquisition system, for the purpose 
of--(section 520(o)(1)(E));
    a. Displaying, analyzing, or printing medical information about a 
patient or other medical information (such as peer-reviewed clinical 
studies and clinical practice guidelines) (section 520(o)(1)(E)(i));
    b. Supporting or providing recommendations to a healthcare 
professional about prevention, diagnosis, or treatment of a disease or 
condition (section 520(o)(1)(E)(ii)); and
    c. Enabling such healthcare professional to independently review 
the basis for such recommendations that such software presents so that 
it is not the intent that such healthcare professional rely primarily 
on any of

[[Page 20280]]

such recommendations to make a clinical diagnosis or treatment decision 
regarding an individual patient (section 520(o)(1)(E)(iii)).
    The Cures Act also provides that a software function described in 
section 520(o)(1)(C), (D), or (E) of the FD&C Act will not be excluded 
from the device definition under section 201(h) of the FD&C Act if FDA 
makes a finding that the software function would be reasonably likely 
to have serious adverse health consequences and certain substantive and 
procedural criteria are met (section 520(o)(3) of the FD&C Act). Also, 
nothing in section 520(o)(1) should exclude regulated software used in 
the manufacture and transfusion of blood and blood components to assist 
in the prevention of disease in humans (section 520(o)(4) of the FD&C 
Act).
    A device, as defined in section 201(h) of the FD&C Act, may be 
comprised of one or more functions that are subject to FDA oversight. 
FDA defines the term ``function'' as a distinct purpose of a product, 
which could be the intended use or a subset of the intended use of the 
product and is not synonymous with the term ``device.'' For example, a 
device with an intended use to analyze data has one function: Analysis. 
A device with an intended use to store, transfer, and analyze data has 
three functions: (1) Storage, (2) transfer, and (3) analysis. Devices 
with ``multiple functions'' may contain functions that are software 
functions excluded from the device definition as described in section 
520(o) of the FD&C Act.
    FDA is issuing this final rule because the FD&C Act was amended by 
the Cures Act to remove certain software functions from the device 
definition, including software functions that are solely intended to 
transfer, store, convert formats, or display medical device data and 
results, including medical images or other clinical information, unless 
such functions are intended to interpret or analyze clinical laboratory 
test or other device data, results, and findings (sections 201(h) and 
520(o)(1)(D) of the FD&C Act).
    FDA is making its regulations consistent with the FD&C Act as 
amended by the Cures Act by amending the ``identification'' 
descriptions in eight regulations so that the descriptions do not 
include software functions that no longer fall within the definition of 
a device. The Agency has conducted a detailed review of all device 
classification regulations to determine whether the classification 
regulations contain software functions identified under section 
520(o)(1)(A)-(E) of the FD&C Act (see 21 CFR parts 862-892), and 
therefore should be amended to reflect changes the Cures Act made to 
FDA's device statutory authority. As a result of this review, FDA 
identified eight classification regulations to amend (see Table 1 
below).
    Because of changes made to the FD&C Act by the Cures Act, the 
``identification'' description of certain classification regulations 
that predated the Cures Act are no longer consistent with the FD&C Act. 
FDA finds good cause for issuing this amendment as a final rule without 
notice and comment because this rule only updates the 
``identification'' description of those classification regulations so 
they reflect changes made to the FD&C Act by the Cures Act (see section 
520(o)(1) of the FD&C Act) (5 U.S.C. 553(b)(3)(B)). In addition, FDA 
also finds good cause for this amendment to become effective on the 
date of publication of this action. The Administrative Procedure Act 
(APA) allows an effective date less than 30 days after publication as 
``provided by the agency for good cause found and published with the 
rule'' (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in 
this case because these amendments reflect the state of the law in 
section 520(o)(1) of the FD&C Act as amended by section 3060 of the 
Cures Act. This rule does not impose any new regulatory requirements on 
affected parties. As a result, affected parties do not need time to 
prepare before the rule takes effect. Therefore, FDA finds good cause 
for these amendments to become effective on the date of publication of 
this action.

IV. Legal Authority

    This final rule is being issued under sections 201(h), 520(o), and 
701 of the FD&C Act and the device and general administrative 
provisions of the FD&C Act sections 501, 510, 513, 515, 520, 522, and 
701.

V. Description of the Final Rule

A. Scope

    FDA is amending the ``identification'' description in eight 
classification regulations, so that they no longer include software 
functions that are excluded from the device definition by section 
520(o)(1) of the FD&C Act and thus are not subject to FDA's device 
statutory authority. Among the software functions excluded from the 
definition of device in the FD&C Act, most relevant to this rule are 
the software functions excluded by section 520(o)(1)(D) of the FD&C 
Act. This provision excludes software functions that are solely 
intended to transfer, store, convert formats, or display, unless such 
functions are intended to interpret or analyze clinical laboratory test 
or other device data, results, and findings. This includes functions 
that are intended for data retrieval, receipt, or transmission because 
these are forms of information ``transfer,'' and functions that are 
intended for data maintenance, which is a form of ``storage'' (section 
520(o)(1)(D) of the FD&C Act; see also FDA guidance ``Changes to 
Existing Medical Software Policies Resulting from Section 3060 of the 
21st Century Cures Act'' (Ref. 1)). However, software functions that 
analyze or interpret medical device data in addition to transferring, 
storing, converting formats, or displaying clinical laboratory test or 
other device data and results remain subject to FDA's regulatory 
oversight, unless they fall within section 520(o)(1)(E) of the FD&C 
Act, which excludes certain clinical decision support software 
functions from the device definition.
    Section 520(o)(1) of the FD&C Act describes software functions, not 
hardware functions, that are excluded from the definition of a device. 
Therefore, device hardware that is specifically intended to transfer, 
store, convert formats, and display medical device data and results 
(such as electrical hardware, magnetic and optical discs, physical 
communications medium, etc.) remains a device.
    In Table 1, we list the regulations that FDA is amending to conform 
the ``identification'' description with the device definition under the 
FD&C Act. The amendments to the ``identification'' description of these 
regulations do not affect the classification of the devices in this 
final rule (i.e., the device types remain class I, class II, etc.).

             Table 1--Classification Regulations Amendments
------------------------------------------------------------------------
                                        Device type (existing product
Classification regulation (21 CFR)                code(s))
------------------------------------------------------------------------
862.2100..........................  Calculator/Data Processing Module
                                     for Clinical Use (JQP, NVV).

[[Page 20281]]

 
862.1350..........................  Continuous Glucose Monitor Secondary
                                     Display (PJT, PKU).
866.4750..........................  Automated Indirect
                                     Immunofluorescence Microscope and
                                     Software-Assisted System (PIV).
880.6310..........................  Medical Device Data System (OUG).
884.2730..........................  Home Uterine Activity Monitor (LQK,
                                     MOH).
892.2010..........................  Medical Image Storage Device (LMB,
                                     NFF).
892.2020..........................  Medical Image Communications Device
                                     (NFG, LMD).
892.2050..........................  Picture Archiving and Communications
                                     System (QIH, OMJ, NWE, PGY, OEB,
                                     QKB, PZO, NFJ, LLZ).
------------------------------------------------------------------------

B. Calculator/Data Processing Module for Clinical Use

    A calculator/data processing module for clinical use is an 
electronic device intended to store, retrieve, and process laboratory 
data (21 CFR 862.2100). Because ``storing and retrieving data'' are 
software functions that no longer fall within the definition of a 
device, FDA is amending the classification regulation to remove the 
language ``store, retrieve, and'' so that the regulation will state: 
``a calculator/data processing module for clinical use is an electronic 
device intended to process laboratory data.''

C. Continuous Glucose Monitor Secondary Display

    A CGM secondary display is identified as a device intended to be 
used for passive real-time monitoring of continuous glucose monitoring 
data Sec.  862.1350 (21 CFR 862.1350). The identification further 
describes that the primary display device, which is not a part of the 
CGM secondary display, directly receives the glucose data (for example, 
it communicates directly with transmitter) from the continuous glucose 
meter, which is not a part of the continuous glucose monitor secondary 
display, and is the primary means of viewing the continuous glucose 
monitor data and alerting the patient to a low or high glucose value. A 
continuous glucose monitor secondary display can be used by caregivers 
of people with diabetes to monitor a person's continuous glucose 
monitoring data.
    The intended use of the device, as explained in FDA's 2015 Dexcom 
Share Direct Secondary Displays (DEN140038) order, includes the 
functions to receive and display medical device data (i.e., real-time 
glucose values and glucose trend information), in addition to functions 
to receive and deliver notifications and alarms. Because of changes 
made to the FD&C Act by the Cures Act, receiving and displaying device 
data software functions are no longer device functions. To make this 
regulation consistent with the FD&C Act, therefore, FDA is amending the 
title of the classification in Sec.  862.1350 to ``continuous glucose 
monitor secondary alarm system'' and is amending the ``identification'' 
description to state that ``a continuous glucose monitor (CGM) 
secondary alarm system is identified as a device intended to be used as 
a secondary alarm for a CGM to enable immediate awareness for potential 
clinical intervention to help assure patient safety.'' With these 
amendments, the regulation no longer includes software functions 
excluded by the Cures Act, i.e., functions to receive and display 
medical device data.

D. Automated Indirect Immunofluorescence Microscope and Software-
Assisted System

    An automated indirect immunofluorescence microscope and software-
assisted system is a device that acquires, analyzes, stores, and 
displays digital images of indirect immunofluorescent slides (21 CFR 
866.4750). FDA is replacing the first occurrence of the word 
``software'' with ``device'' in the identification section, so that the 
identification will state that the device may use fluorescent signal 
acquisition and processing software, data storage and transferring 
mechanisms, or assay specific algorithms to suggest results. Because 
some of the software functions included in the regulation remain within 
the device definition (e.g., assay specific algorithms to suggest 
results), the ``identification'' description will not be limited to 
hardware functions only. Instead, FDA is using the term ``device,'' 
which includes software functions that continue to fall within the 
device definition and hardware functions.

E. Medical Device Data System

    An MDDS is intended to provide one or more of the following uses, 
without controlling or altering the functions or parameters of any 
connected medical devices: (1) The electronic transfer of medical 
device data; (2) the electronic storage of medical device data; (3) the 
electronic conversion of medical device data from one format to another 
format in accordance with a preset specification; or (4) the electronic 
display of medical device data (Sec.  880.6310 (21 CFR 880.6310)). An 
MDDS may include software, electronic or electrical hardware such as a 
physical communications medium (including wireless hardware), modems, 
interfaces, and a communications protocol. Each MDDS function ((1)-(4)) 
describes a software function that is excluded from the device 
definition under section 520(o)(1)(D) of the FD&C Act. Thus, FDA is 
amending the regulation to state that only hardware that performs these 
functions remain within the definition of devices by adding the term 
``hardware'' to the ``identification'' description so that the 
regulation (Sec.  880.6310(a)(1)) states that an MDDS is a ``hardware 
device that is intended to provide one or more of the following uses . 
. .''.
    In addition, FDA is amending Sec.  880.6310(a)(2) to remove the 
term ``software,'' because the software functions described in the 
identification of Sec.  880.6310(a)(2) no longer fall within the 
definition of a device. Further, FDA is removing the phrase ``a 
communications protocol'' from Sec.  880.6310(a)(2), because the term 
``communications protocol'' refers to software functions associated 
with the transfer of data, and this function does not fall within the 
definition of a device. FDA is also amending the identification of 
Sec.  880.6310(a)(2) to include the term ``hardware,'' such that the 
``identification'' description states that MDDS ``does not include 
hardware devices intended to be used in connection with active patient 
monitoring.'' FDA is revising this identification because hardware 
devices for active patient monitoring are classified under other 
regulations for software- and hardware-based devices, and are not 
included in this regulation. The identification of Sec.  880.6310(a)(2) 
will be amended to include the following: ``Hardware devices for active 
patient monitoring are classified under other regulations and are not 
included in this regulation.''

[[Page 20282]]

F. Home Uterine Activity Monitor

    A HUAM is an electronic system for at home antepartum measurement 
of uterine contractions, data transmission by telephone to a clinical 
setting, and for receipt and display of the uterine contraction data at 
the clinic (21 CFR 884.2730). The HUAM system comprises a 
tocotransducer, an at-home recorder, a modem, and a computer and 
monitor that receive, process, and display data. This device is 
intended for use in women with a previous preterm delivery to aid in 
the detection of preterm labor. The identification in the 
classification regulation for this device includes software functions 
intended to transmit, receive, and display data, which no longer fall 
within the statutory definition of a device. Therefore, FDA is removing 
these software functions from the ``identification'' description in 
this classification regulation.

G. Medical Image Storage Device

    A medical image storage device is a device that provides electronic 
storage and retrieval functions for medical images and may employ 
software, electronic, or electrical hardware such as magnetic and 
optical discs, magnetic tape, and digital memory (Sec.  892.2010 (21 
CFR 892.2010)). Medical image storage includes software functions, 
specifically storage and retrieval functions, which are excluded from 
the device definition by section 520(o)(1)(D) of the FD&C Act. Thus, 
FDA is amending the regulation to state that only hardware that 
performs these functions remains within the device definition so that 
the regulation (Sec.  892.2010(a)(1)) states that a medical image 
storage device is a ``hardware device that is intended to provide for 
the electronic storage and retrieval functions for medical images.''

H. Medical Image Communications Device

    A medical image communications device provides electronic transfer 
of medical image data between medical devices (21 CFR 892.2020). The 
device may include a physical communications medium, modems, or 
interfaces. In reviewing this classification regulation, FDA has 
determined that products with specific software functions for medical 
image processing and manipulation should be mentioned in the 
``identification'' description of the classification regulation because 
such functions have always been included in the regulation and are not 
excluded under section 520(o)(1)(D) of the FD&C Act. Therefore, FDA is 
amending this regulation to include the following clarifying language 
to the ``identification'' description: ``It may provide simple image 
review software functionality for medical image processing and 
manipulation, such as grayscale window and level, zoom and pan, user 
delineated geometric measurements, compression, or user added image 
annotations. The device does not perform advanced image processing or 
complex quantitative functions. This does not include electronic 
transfer of medical image software functions.''

I. Picture Archiving and Communications System

    The Picture Archiving and Communications Systems (PACS) device 
includes both software and hardware image storage and display functions 
and software image processing functions (21 CFR 892.2050). FDA has 
determined that software functions in the PACS classification 
regulation for storage and display of medical images no longer fall 
within the definition of a device under section 520(o)(1)(D) of the 
FD&C Act. However, FDA recognizes that some software functions in the 
PACS regulation, which are for complex image processing, including 
those for image manipulation, enhancement, or quantification, remain 
device functions. Therefore, FDA is amending this regulation to change 
the title of the classification regulation from ``Picture Archiving and 
Communications Systems'' to ``Medical Image Management and Processing 
System'' and is amending the ``identification'' description to exclude 
software functions for the ``storage and display'' of medical images. 
In addition, the amendment to the PACS classification regulation 
clarifies specific functions and the device's intended use with 
examples in the ``identification'' description.

VI. Effective Date

    This final rule is effective on the date of publication in the 
Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866, 
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Because this final rule 
merely amends certain classification regulations to remove provisions 
that are now obsolete in order to conform to the medical software 
provisions in the Cures Act, it does not impose any additional 
regulatory burdens. Therefore, we believe that this final rule is not 
economically significant and not a significant regulatory action as 
defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this regulation does not change requirements, and 
amends certain classification regulations to conform to the medical 
software provisions in the Cures Act, we certify that the final rule 
will not have a significant economic impact on a substantial number of 
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $158 
million, using the most current (2020) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    Because this direct final rule does not impose any additional 
regulatory burdens, this regulation is not anticipated to result in any 
compliance costs.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(i) and 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

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

X. Federalism

    We have analyzed this rule in accordance with the principles set 
forth in E.O. 13132. We have determined that this rule does not contain 
policies that

[[Page 20283]]

have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, we conclude that the rule does not contain policies that 
have federalism implications as defined in the E.O. and, consequently, 
a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in E.O. 13175. We have determined that the rule does not contain 
policies that have substantial direct effects on one or more Indian 
Tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes. Accordingly, we conclude that 
the rule does not contain policies that have tribal implications as 
defined in the E.O. and, consequently, a tribal summary impact 
statement is not required.

XII. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

    1. FDA Guidance, Changes to Existing Medical Software Policies 
Resulting from Section 3060 of the 21st Century Cures Act, available 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act.

List of Subjects

21 CFR Part 862

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 880

    Medical devices.

21 CFR Part 884

    Medical devices.

21 CFR Part 892

    Medical devices, Radiation protection, and X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR 
parts 862, 866, 880, 884, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

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

0
2. Amend Sec.  862.1350 by revising the section heading and paragraph 
(a) to read as follows:

Sec.  862.1350   Continuous glucose monitor secondary alarm system.

    (a) Identification. A continuous glucose monitor (CGM) secondary 
alarm system is identified as a device intended to be used as a 
secondary alarm for a CGM to enable immediate awareness for potential 
clinical intervention to help assure patient safety.
* * * * *

0
3. Amend Sec.  862.2100 by revising paragraph (a) to read as follows:

Sec.  862.2100   Calculator/data processing module for clinical use.

    (a) Identification. A calculator/data processing module for 
clinical use is an electronic device intended to process laboratory 
data.
* * * * *

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
4. The authority citation for part 866 continues to read as follows:

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

0
5. Amend Sec.  866.4750 by revising paragraph (a) to read as follows:

Sec.  866.4750   Automated indirect immunofluorescence microscope and 
software-assisted system.

    (a) Identification. An automated indirect immunofluorescence 
microscope and software assisted system is a device that acquires, 
analyzes, stores, and displays digital images of indirect 
immunofluorescent slides. It is intended to be used as an aid in the 
determination of antibody status in clinical samples. The device may 
include a fluorescence microscope with light source, a motorized 
microscope stage, dedicated instrument controls, a camera, a computer, 
a sample processor, or other hardware components. The device may use 
fluorescent signal acquisition and processing software, data storage 
and transferring mechanisms, or assay specific algorithms to suggest 
results. A trained operator must confirm results generated with the 
device.
* * * * *

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
6. The authority citation for part 880 continues to read as follows:

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

0
7. Amend Sec.  880.6310 by revising paragraph (a) to read as follows:

Sec.  880.6310   Medical device data system.

    (a) Identification. (1) A medical device data system (MDDS) is a 
hardware device that is intended to provide one or more of the 
following uses, without controlling or altering the functions or 
parameters of any connected medical devices:
    (i) The electronic transfer of medical device data;
    (ii) The electronic storage of medical device data;
    (iii) The electronic conversion of medical device data from one 
format to another format in accordance with a preset specification; or
    (iv) The electronic display of medical device data.
    (2) An MDDS may include electronic or electrical hardware such as a 
physical communications medium (including wireless hardware), modems, 
and interfaces. This identification does not include hardware devices 
intended to be used in connection with active patient monitoring. 
Hardware devices for active patient monitoring are classified under 
other regulations and are not included in this regulation.
* * * * *

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
8. The authority citation for part 884 continues to read as follows:

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

0
9. Amend Sec.  884.2730 by revising paragraph (a) to read as follows:

Sec.  884.2730   Home uterine activity monitor.

    (a) Identification. A home uterine activity monitor (HUAM) is an 
electronic system for at home antepartum measurement of uterine 
contractions. The HUAM system comprises a tocotransducer and an at-home 
recorder. This device is intended for use in women with a previous 
preterm delivery to aid in the detection of preterm labor.
* * * * *

[[Page 20284]]

PART 892--RADIOLOGY DEVICES

0
10. The authority citation for part 892 continues to read as follows:

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

0
11. Amend Sec.  892.2010 by revising paragraph (a) to read as follows:

Sec.  892.2010   Medical image storage device.

    (a) Identification: A medical image storage device is a hardware 
device that provides electronic storage and retrieval functions for 
medical images. Examples include electronic hardware devices employing 
magnetic and optical discs, magnetic tapes, and digital memory.
* * * * *

0
12. Amend Sec.  892.2020 by revising paragraph (a) to read as follows:

Sec.  892.2020   Medical image communications device.

    (a) Identification. A medical image communications device provides 
electronic transfer of medical image data between medical devices. It 
may include a physical communications medium, modems, and interfaces. 
It may provide simple image review software functionality for medical 
image processing and manipulation, such as grayscale window and level, 
zoom and pan, user delineated geometric measurements, compression, or 
user added image annotations. The device does not perform advanced 
image processing or complex quantitative functions. This does not 
include electronic transfer of medical image software functions.
* * * * *

0
13. Amend Sec.  892.2050 by revising the section heading and paragraph 
(a) to read as follows:

Sec.  892.2050   Medical image management and processing system.

    (a) Identification. A medical image management and processing 
system is a device that provides one or more capabilities relating to 
the review and digital processing of medical images for the purposes of 
interpretation by a trained practitioner of disease detection, 
diagnosis, or patient management. The software components may provide 
advanced or complex image processing functions for image manipulation, 
enhancement, or quantification that are intended for use in the 
interpretation and analysis of medical images. Advanced image 
manipulation functions may include image segmentation, multimodality 
image registration, or 3D visualization. Complex quantitative functions 
may include semi-automated measurements or time-series measurements.
* * * * *

    Dated: April 8, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 13, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07860 Filed 4-16-21; 8:45 am]
BILLING CODE 4164-01-P