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

Citation86 FR 20278
Record Number2021-07860
Published date19 April 2021
SectionRules and Regulations
CourtFood And Drug Administration
Federal Register, Volume 86 Issue 73 (Monday, April 19, 2021)
[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:
                [email protected].
                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
                

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