Document ID: FDA-2016-D-2483-0019
Agency: fda
Document Type: Notice
Title: Software as a Medical Device: Clinical Evaluation; International Medical
Device Regulators Forum; Guidance for Industry and Food and Drug
Administration Staff; Availability
Posted Date: 2017-12-08T05:00Z

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57994-57996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2483]

Software as a Medical Device: Clinical Evaluation; International 
Medical Device Regulators Forum; Guidance for Industry and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 57995]]

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Software as a Medical 
Device (SaMD): Clinical Evaluation.'' This guidance was prepared as 
part of the FDA's international convergence efforts under the auspices 
of the International Medical Device Regulators Forum (IMDRF), formerly 
the Global Harmonization Task Force. The guidance, informed by global 
and U.S. public comments, pertains to Software as a Medical Device 
(SaMD) and focuses on principles of clinical evaluation, which include 
establishing the scientific validity, clinical performance, and 
analytical validity for SaMD. The guidance is intended to provide 
globally harmonized principles of when and what type of clinical 
evaluation is appropriate based on the risk of the SaMD.

DATES: The announcement of the guidance is published in the Federal 
Register on December 8, 2017.

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-2016-D-2483 for ``Software as a Medical Device (SaMD): Clinical 
Evaluation.'' 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.
     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.gpo.gov/fdsys/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.
    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 
``Software as a Medical Device (SaMD): Clinical Evaluation'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire 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: Regarding the guidance: Bakul Patel, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver 
Spring, MD 20993-0002, 301-796-5528.
    Regarding the IMDRF: Melissa A. Torres, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5432, Silver Spring, MD 20993-0002, 301-796-5576.

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities across the globe to promote international 
harmonization and convergence of regulatory requirements. One of the 
goals of global convergence is to identify and reduce differences in 
regulatory approaches among regulatory agencies. IMDRF seeks to advance 
international convergence in the approach towards medical device 
regulation with input from both regulatory and industry 
representatives. The current members of the Management Committee of the 
IMDRF are regulatory officials from Australia (Therapeutic Goods 
Administration), Brazil (National Health Surveillance Agency), Canada 
(Health Canada), China (China Food and Drug Administration), European 
Union (European Commission Directorate-General for Internal Market, 
Industry, Entrepreneurship, and Small and Medium-sized Enterprises), 
Japan (Pharmaceuticals and Medical Devices Agency and the Ministry of 
Health, Labour, and Welfare), Russia (Ministry of Healthcare), 
Singapore (Health

[[Page 57996]]

Sciences Authority), and the United States (U.S. FDA). The World Health 
Organization and the Asia-Pacific Economic Cooperation Life Sciences 
Innovation Forum Regulatory Harmonization Steering Committee are IMDRF 
Official Observers. The Asian Harmonization Working Party and the Pan 
American Health Organization are IMDRF Affiliate Organizations.
    The IMDRF Management Committee (IMDRF MC) chartered the SaMD 
Working Group (WG) to develop a regulatory framework for SaMD and to 
develop converged principles for global regulators to adopt in their 
respective jurisdictions. The SaMD WG includes representatives from the 
IMDRF members, industry, academia, and other key stakeholders as well 
as regional harmonization initiatives from around the world.
    The IMDRF SaMD WG considered comments received on the draft 
guidance that was announced in the Federal Register of October 14, 2016 
(81 FR 71105). The SaMD WG also considered public comments received by 
other regulators and from other global stakeholders. The final IMDRF/
SaMD WG/N41 document, ``Software as a Medical Device (SaMD): Clinical 
Evaluation,'' submitted to IMDRF MC was revised appropriately in 
response to all of the comments. The IMDRF MC in Ottawa, Canada, at the 
12th meeting held from September 19 to 21, 2017, unanimously approved 
the document entitled ``Software as a Medical Device (SaMD): Clinical 
Evaluation.'' This final IMDRF/SaMD WG/N41 document is available for 
regulatory implementation according to the regulatory process in each 
jurisdiction.
    This guidance adopts the internationally converged principles 
agreed upon by the IMDRF. FDA adoption of these principles provides FDA 
with an initial framework when further developing the Agency's specific 
regulatory approaches and expectations for regulatory oversight. This 
guidance does not provide recommendations for FDA Staff and Industry to 
apply to specific regulatory situations, nor does it modify current 
regulatory expectations, including those for regulatory submissions, at 
this time. FDA intends to consider the principles of this guidance in 
the development of regulatory approaches for SaMD and digital health 
technologies. In developing regulatory approaches based on the 
principles of this guidance, the Agency intends to follow a public 
process, including providing opportunities for public input. For more 
information on FDA adoption of IMDRF documents as an FDA guidance 
document, please see https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm.

II. Significance of Guidance

    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 ``Software as a Medical Device (SaMD): 
Clinical Evaluation.'' 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. This guidance is not subject to Executive Order 12866.

III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Software as a 
Medical Device (SaMD): Clinical Evaluation'' may send an email request 
to [email protected] to receive an electronic copy of the 
document. Please use the document number 16039 to identify the guidance 
you are requesting.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26441 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P