
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71105-71106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24805]


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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Medical Device Regulators Forum; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``Software as a Medical 
Device (SaMD): Clinical Evaluation.'' The draft guidance was prepared 
under the auspices of the International Medical Device Regulators Forum 
(IMDRF), formerly the Global Harmonization Task Force. The draft 
guidance pertains to the conduct of clinical evaluation of Software as 
a Medical Device (SaMD) and focuses on the general principles of 
clinical evaluation, which includes establishing the scientific 
validity, clinical performance, and analytical validity for a SaMD. The 
draft guidance is intended to provide globally harmonized principles of 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. This draft guidance is not final nor is it in effect 
at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 draft 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

[[Page 71106]]

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 requests.

FOR FURTHER INFORMATION CONTACT: Regarding the draft 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 and industry associations to promote 
international harmonization of regulatory requirements. One of the 
goals of global harmonization is to identify and then reduce 
differences in regulatory policies among regulatory agencies. IMDRF 
seeks to advance international harmonization or convergence of medical 
device regulation.
    IMDRF was organized to provide an opportunity for global 
harmonization initiatives to be developed 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), 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 Official Observers. The Asian Harmonization Working Party and the 
Pan American Health Organization are IMDRF Affiliate Organizations.
    In September 2016, the IMDRF Management Committee endorsed the 
draft guidance entitled ``Software as a Medical Device (SaMD): Clinical 
Evaluation'' and agreed that the guidance should be made available for 
public comment. The IMDRF SaMD Working Group (WG) includes 
representatives from the IMDRF members, as well as members from the 
Medical Device Regulatory Authorities and Regional Harmonization 
Initiatives from around the world. The draft guidance is the product of 
the IMDRF SaMD WG. Comments about this draft will be considered by FDA 
and the IMDRF SaMD WG.
    We welcome comments on all aspects of the draft guidance as well as 
the following specific issues:
    1. Does the document address the intention captured in the 
introduction/scope or vice versa?
    2. Does the document appropriately translate and apply current 
clinical vocabulary for SaMD?
    3. Are there other types of SaMD beyond those intended for non-
diagnostic, diagnostic and therapeutic purposes that should be 
highlighted/considered in the document?
    4. Does the document adequately address the relevant clinical 
evaluation methods and processes for SaMD to generate clinical 
evidence?
    5. Are there other appropriate methods for generating clinical 
evaluation evidence that are relevant for SaMD beyond those described 
in the document?
    6. Are the recommendations identified in section 7.2 related to the 
``importance of clinical evidence and expectations'' appropriate as 
outlined for the different SaMD categories?
    7. Are the recommendations identified in section 7.3 related to the 
``importance of independent review'' appropriate as outlined for the 
different SaMD categories?
    8. Given the uniqueness of SaMD and the proposed framework--is 
there any impact on currently regulated devices or any possible adverse 
consequences?
    The draft guidance and the IMDRF comment page are available at 
http://www.imdrf.org/consultations/consultations.asp#current.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://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 CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16039 to identify the guidance you are 
requesting.

    Dated: October 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24805 Filed 10-13-16; 8:45 am]
BILLING CODE 4164-01-P


