[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]
-----------------------------------------------------------------------
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Medical Device Regulators Forum; Draft Guidance for Industry;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.
-----------------------------------------------------------------------
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the availability of a draft guidance entitled ``Software as a Medical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 The draft guidance was prepared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 The draft
guidance pertains to the conduct of clinical evaluation of Software as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draft guidance is intended to provide globally harmonized principles of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 This draft guidance is not final nor is it in effect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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 13, 2016.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 [email protected] 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