Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability, 58810-58812 [2022-20993]

Download as PDF 58810 Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices Enforcement Data Management Branch (DCIJA2) Division of Import Systems Solutions (DCIJB) Import Systems Branch (DCIJB1) Import Data Management Branch (DCIJB2) Division of Information Technology Planning and Management Services (DCIJC) Solutions Planning Branch (DCIJC1) Information Technology Management and Governance Services Branch (DCIJC2) Delegations of Authority Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization. Electronic Access This reorganization is reflected in FDA’s Staff Manual Guide (SMG). Persons interested in seeing the complete Staff Manual Guide can find it on FDA’s website at: https:// www.fda.gov/AboutFDA/ ReportsManualsForms/ StaffManualGuides/default.htm. (Authority: 44 U.S.C. 3101) Dated: September 23, 2022. Xavier Becerra, Secretary of Health and Human Services. [FR Doc. 2022–20996 Filed 9–27–22; 8:45 am] BILLING CODE P Food and Drug Administration [Docket No. FDA–2017–D–6569] Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Clinical Decision Support Software.’’ This final guidance provides clarity on FDA’s oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA’s regulatory approach to CDS software lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:06 Sep 27, 2022 Jkt 256001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). DATES: The announcement of the guidance is published in the Federal Register on September 28, 2022. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. [FDA– 2017–D–6569] for ‘‘Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire E:\FR\FM\28SEN1.SGM 28SEN1 Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Brendan O’Leary, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993–0002, 301–796–6898; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911 or Kristina Lauritsen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993–0002, 301– 796–8936. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 I. Background FDA has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)), including software that is intended to provide decision support to health care professionals, patients, or caregivers for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as CDS software). Section 3060(a) of the Cures Act, enacted on December 13, 2016 (Pub. L. 114–255), amended section 520 of the FD&C Act (21 U.S.C. 360j) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C Act. This guidance describes CDS software functions that do not meet the definition of a device in the context of and based on the criteria from section 520(o) of the FD&C Act. This guidance also further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. For example, some decision support software functions may be identified in other guidance documents as software functions for which, based on our current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and approval requirements. A notice of availability of the draft guidance appeared in the Federal Register of September 27, 2019 (84 FR 51167). FDA considered comments received and revised the guidance as appropriate in response to the comments. In this final guidance, FDA provides clarification on the terminology of ‘‘Clinical Decision Support’’ and focuses solely on the criteria for Non-Device CDS. In response to comments received, the final guidance no longer contains complementary information from the International Medical Device Regulators Forum risk categories, and the guidance provides additional explanation for how a software function, regardless of its complexity, can be intended for the purpose of enabling a healthcare professional to independently review the basis for the software function’s recommendations, such that the recommendations are not primarily relied upon by the healthcare professional. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Clinical Decision Support Software. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 58811 II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances, or https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs. Persons unable to download an electronic copy of ‘‘Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400062 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following: 21 CFR part; guidance; or FDA form Topic 807, subpart E .......................................................................... 814, subparts A through E ....................................................... 814, subpart H .......................................................................... 812 ............................................................................................ ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. 800, 801, and 809 .................................................................... 314 ............................................................................................ 601; Form FDA 356h ................................................................ Premarket notification .............................................................. Premarket approval .................................................................. Humanitarian Device Exemption .............................................. Investigational Device Exemption ............................................ De Novo classification process ................................................ 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Medical Device Labeling Regulations ...................................... Applications for FDA Approval to Market a New Drug ............ Biologics License; Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use—Form FDA 356h. 0910–0485 0910–0001 0910–0338 VerDate Sep<11>2014 18:06 Sep 27, 2022 Jkt 256001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM OMB control No. 28SEN1 58812 Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices Dated: September 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–20993 Filed 9–27–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–4040–0010] Agency Information Collection Request; 60-Day Public Comment Request AGENCY: ACTION: Comments on the ICR must be received on or before November 28, 2022. ADDRESSES: Submit your comments to sagal.musa@hhs.gov or by calling (202) 205–2634. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 4040–0010–60D and project title for reference, to Sagal Musa, email: sagal.musa@hhs.gov, or call (202) 205–2634 the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection DATES: Office of the Secretary, HHS. Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. SUMMARY: techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms. Type of Collection: Renewal. OMB No. 4040–0010. Abstract: The Project/Performance Site Location(s), Project Abstract, and Key Contacts forms provide the Federal grant-making agencies an alternative to the Standard Form 424 data set and form. Agencies may use Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms for grant programs not required to collect all the data that is required on the SF– 424 core data set and form. Type of respondent: Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms are used by organizations to apply for Federal financial assistance in the form of grants. This form is submitted to the Federal grant-making agencies for evaluation and review. ANNUALIZED BURDEN HOUR TABLE Number of respondents Average burden per response Respondents (if necessary) Project/Performance Site Location(s) Project Abstract ................................. Key Contacts ..................................... Grant Applicants ............................... Grant Applicants ............................... Grant Applicants ............................... 127,281 230 4,566 1 1 1 1 1 1 127,281 230 4,566 Total ........................................... ........................................................... 132,077 1 1 132,077 Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. Bethesdan Hotel, Tapestry Collection by Hilton. The address remains unchanged. The meeting is closed to the public. [FR Doc. 2022–21013 Filed 9–27–22; 8:45 am] Dated: September 22, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4151–AE–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2022–20929 Filed 9–27–22; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondents Forms (if necessary) Center for Scientific Review; Amended Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice is hereby given of a change in the meeting of the Instrumentation and Systems Development Study Section, October 4, 2022, 6:30 a.m. to October 5, 6:00 p.m., Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814, which was published in the Federal Register on September 07, 2022, 87 FR 54706, Doc 2022–19211. This meeting is being amended to change the start time from 6:30 a.m. to 8:00 a.m. and the name of the hotel from the Doubletree Hotel Bethesda to The National Institutes of Health VerDate Sep<11>2014 18:06 Sep 27, 2022 Jkt 256001 National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Total burden hours as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA NRSA Institutional Research Training Centers (T32/T35) Review Panel. Date: October 6, 2022. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Beata Buzas, Ph.D., Scientific Review Officer, Extramural Project Review Branch, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Room 2116, MSC 6902, Bethesda, MD 20892, (301) 443–0800, bbuzas@mail.nih.gov. E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58810-58812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20993]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6569]


Clinical Decision Support Software; Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Clinical Decision 
Support Software.'' This final guidance provides clarity on FDA's 
oversight of clinical decision support (CDS) software intended for 
health care professionals with the purpose of describing FDA's 
regulatory approach to CDS software functions. This guidance clarifies 
the types of CDS functions that do not meet the definition of a device 
as amended by the 21st Century Cures Act (Cures Act).

DATES: The announcement of the guidance is published in the Federal 
Register on September 28, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
[FDA-2017-D-6569] for ``Clinical Decision Support Software; Guidance 
for Industry and Food and Drug Administration Staff.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Clinical Decision Support Software; Guidance for Industry and Food 
and Drug Administration Staff'' to the Office of Policy, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire

[[Page 58811]]

Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Brendan O'Leary, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911 or Kristina 
Lauritsen, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver 
Spring, MD 20993-0002, 301-796-8936.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has long regulated software that meets the definition of a 
device in section 201(h) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 321(h)), including software that is intended to 
provide decision support to health care professionals, patients, or 
caregivers for the diagnosis, treatment, prevention, cure, or 
mitigation of diseases or other conditions (often referred to as CDS 
software). Section 3060(a) of the Cures Act, enacted on December 13, 
2016 (Pub. L. 114-255), amended section 520 of the FD&C Act (21 U.S.C. 
360j) to exclude certain medical software functions, including certain 
decision support software, from the definition of device under section 
201(h) of the FD&C Act.
    This guidance describes CDS software functions that do not meet the 
definition of a device in the context of and based on the criteria from 
section 520(o) of the FD&C Act. This guidance also further clarifies 
that FDA's existing digital health policies continue to apply to 
software functions that meet the definition of a device, including 
those that are intended for use by patients or caregivers. For example, 
some decision support software functions may be identified in other 
guidance documents as software functions for which, based on our 
current understanding of the risks of these software functions, FDA 
does not intend at this time to enforce compliance with applicable 
device requirements of the FD&C Act, including, but not limited to, 
premarket clearance and approval requirements.
    A notice of availability of the draft guidance appeared in the 
Federal Register of September 27, 2019 (84 FR 51167). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments. In this final guidance, FDA provides clarification on 
the terminology of ``Clinical Decision Support'' and focuses solely on 
the criteria for Non-Device CDS. In response to comments received, the 
final guidance no longer contains complementary information from the 
International Medical Device Regulators Forum risk categories, and the 
guidance provides additional explanation for how a software function, 
regardless of its complexity, can be intended for the purpose of 
enabling a healthcare professional to independently review the basis 
for the software function's recommendations, such that the 
recommendations are not primarily relied upon by the healthcare 
professional.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Clinical Decision Support Software. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 
Persons unable to download an electronic copy of ``Clinical Decision 
Support Software; Guidance for Industry and Food and Drug 
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1400062 and complete title to identify 
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations, guidance, and forms 
have been approved by OMB as listed in the following:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                        Topic           OMB control No.
------------------------------------------------------------------------
807, subpart E................  Premarket notification         0910-0120
814, subparts A through E.....  Premarket approval....         0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational Device         0910-0078
                                 Exemption.
``De Novo Classification        De Novo classification         0910-0844
 Process (Evaluation of          process.
 Automatic Class III
 Designation)''.
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
314...........................  Applications for FDA           0910-0001
                                 Approval to Market a
                                 New Drug.
601; Form FDA 356h............  Biologics License;             0910-0338
                                 Application to Market
                                 a New Drug or
                                 Abbreviated New Drug
                                 or Biologic for Human
                                 Use--Form FDA 356h.
------------------------------------------------------------------------



[[Page 58812]]

    Dated: September 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20993 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.