81 FR 71105 - Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 199 (October 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 199 (October 14, 2016)
| Page Range | 71105-71106 | |
| FR Document | 2016-24805 |
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)] [Notices] [Pages 71105-71106] From the Federal Register Online [www.thefederalregister.org] [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No. FDA-2016-D-2483] Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Software as a Medical Device (SaMD): Clinical Evaluation.'' The draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The draft guidance pertains to the conduct of clinical evaluation of Software as a Medical Device (SaMD) and focuses on the general principles of clinical evaluation, which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 The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD. This draft guidance is not final nor is it in effect at this time.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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 13, 2016.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
![Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices 71105
consortium of consumer-oriented clinical evaluation is appropriate based Evaluation.’’ Received comments will be
organizations or other interested on the risk of the SaMD. This draft placed in the docket and, except for
persons. In addition to the voting guidance is not final nor is it in effect those submitted as ‘‘Confidential
members, the Committee may include at this time. Submissions,’’ publicly viewable at
one non-voting member who is DATES: Although you can comment on http://www.regulations.gov or at the
identified with industry interests. any guidance at any time (see 21 CFR Division of Dockets Management
Further information regarding the 10.115 (g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
most recent charter and other considers your comment on this draft through Friday.
information can be found at http:// guidance before it begins work on the • Confidential Submissions—To
www.fda.gov/AdvisoryCommittees/ final version of the guidance, submit submit a comment with confidential
CommitteesMeetingMaterials/Drugs/ either electronic or written comments information that you do not wish to be
DermatologicandOphthalmic on the draft guidance by December 13, made publicly available, submit your
DrugsAdvisoryCommittee/ 2016. comments only as a written/paper
ucm094782.htm or by contacting the submission. You should submit two
ADDRESSES: You may submit comments
Designated Federal Officer (see FOR copies total. One copy will include the
FURTHER INFORMATION CONTACT). In light
as follows: information you claim to be confidential
of the fact that no change has been made Electronic Submissions with a heading or cover note that states
to the committee name or description of ‘‘THIS DOCUMENT CONTAINS
duties, no amendment will be made to Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
21 CFR 14.100. following way: Agency will review this copy, including
This document is issued under the • Federal eRulemaking Portal: http:// the claimed confidential information, in
Federal Advisory Committee Act (5 www.regulations.gov. Follow the its consideration of comments. The
U.S.C. app.). For general information instructions for submitting comments. second copy, which will have the
related to FDA advisory committees, Comments submitted electronically, claimed confidential information
please visit us at http://www.fda.gov/ including attachments, to http:// redacted/blacked out, will be available
AdvisoryCommittees/default.htm. www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
Dated: October 7, 2016.
comment will be made public, you are copies to the Division of Dockets
Janice M. Soreth, solely responsible for ensuring that your
Acting Associate Commissioner, Special
Management. If you do not wish your
comment does not include any name and contact information to be
Medical Programs. confidential information that you or a
[FR Doc. 2016–24816 Filed 10–13–16; 8:45 am]
made publicly available, you can
third party may not wish to be posted, provide this information on the cover
BILLING CODE 4164–01–P such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
HUMAN SERVICES information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Food and Drug Administration information, or other information that accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
[Docket No. FDA–2016–D–2483] comments, that information will be information about FDA’s posting of
posted on http://www.regulations.gov. comments to public dockets, see 80 FR
Software as a Medical Device: Clinical • If you want to submit a comment
Evaluation; International Medical 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
Device Regulators Forum; Draft do not wish to be made available to the
Guidance for Industry; Availability regulatoryinformation/dockets/
public, submit the comment as a default.htm.
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Written/Paper Submissions received, go to http://
SUMMARY: The Food and Drug www.regulations.gov and insert the
Administration (FDA or Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing the availability of a draft follows: heading of this document, into the
guidance entitled ‘‘Software as a • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
Medical Device (SaMD): Clinical written/paper submissions): Division of and/or go to the Division of Dockets
Evaluation.’’ The draft guidance was Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
prepared under the auspices of the and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
International Medical Device Regulators Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance
Forum (IMDRF), formerly the Global • For written/paper comments document is available for download
Harmonization Task Force. The draft submitted to the Division of Dockets from the Internet. See the
guidance pertains to the conduct of Management, FDA will post your SUPPLEMENTARY INFORMATION section for
clinical evaluation of Software as a comment, as well as any attachments, information on electronic access to the
Medical Device (SaMD) and focuses on except for information submitted, guidance. Submit written requests for a
rmajette on DSK2TPTVN1PROD with NOTICES
the general principles of clinical marked and identified, as confidential, single hard copy of the draft guidance
evaluation, which includes establishing if submitted as detailed in document entitled ‘‘Software as a
the scientific validity, clinical ‘‘Instructions.’’ Medical Device (SaMD): Clinical
performance, and analytical validity for Instructions: All submissions received Evaluation’’ to the Office of the Center
a SaMD. The draft guidance is intended must include the Docket No. FDA– Director, Guidance and Policy
to provide globally harmonized 2016–D–2483 for ‘‘Software as a Development, Center for Devices and
principles of when and what type of Medical Device (SaMD): Clinical Radiological Health, Food and Drug
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![71106 Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
Administration, 10903 New Hampshire public comment. The IMDRF SaMD III. Electronic Access
Ave., Bldg. 66, Rm. 5431, Silver Spring, Working Group (WG) includes Persons interested in obtaining a copy
MD 20993–0002. Send one self- representatives from the IMDRF of the draft guidance may do so by
addressed adhesive label to assist that members, as well as members from the downloading an electronic copy from
office in processing your requests. Medical Device Regulatory Authorities the Internet. A search capability for all
FOR FURTHER INFORMATION CONTACT: and Regional Harmonization Initiatives Center for Devices and Radiological
Regarding the draft guidance: Bakul from around the world. The draft Health guidance documents is available
Patel, Center for Devices and guidance is the product of the IMDRF at http://www.fda.gov/MedicalDevices/
Radiological Health, Food and Drug SaMD WG. Comments about this draft DeviceRegulationandGuidance/
Administration, 10903 New Hampshire will be considered by FDA and the GuidanceDocuments/default.htm.
Ave., Bldg. 66, Rm. 5458, Silver Spring, IMDRF SaMD WG. Guidance documents are also available
MD 20993–0002, 301–796–5528. We welcome comments on all aspects at http://www.regulations.gov. Persons
Regarding the IMDRF: Melissa A. of the draft guidance as well as the unable to download an electronic copy
Torres, Center for Devices and following specific issues: of ‘‘Software as a Medical Device
Radiological Health, Food and Drug 1. Does the document address the (SaMD): Clinical Evaluation’’ may send
Administration, 10903 New Hampshire intention captured in the introduction/ an email request to CDRH-Guidance@
Ave., Bldg. 66, Rm. 5432, Silver Spring, scope or vice versa? fda.hhs.gov to receive an electronic
MD 20993–0002, 301–796–5576. copy of the document. Please use the
2. Does the document appropriately
SUPPLEMENTARY INFORMATION: translate and apply current clinical document number 16039 to identify the
vocabulary for SaMD? guidance you are requesting.
I. Background
3. Are there other types of SaMD Dated: October 6, 2016.
In recent years, many important
initiatives have been undertaken by beyond those intended for non- Leslie Kux,
regulatory authorities and industry diagnostic, diagnostic and therapeutic Associate Commissioner for Policy.
associations to promote international purposes that should be highlighted/ [FR Doc. 2016–24805 Filed 10–13–16; 8:45 am]
harmonization of regulatory considered in the document? BILLING CODE 4164–01–P
requirements. One of the goals of global 4. Does the document adequately
harmonization is to identify and then address the relevant clinical evaluation
reduce differences in regulatory policies methods and processes for SaMD to DEPARTMENT OF HEALTH AND
among regulatory agencies. IMDRF generate clinical evidence? HUMAN SERVICES
seeks to advance international 5. Are there other appropriate
Food and Drug Administration
harmonization or convergence of methods for generating clinical
medical device regulation. evaluation evidence that are relevant for [Docket No. FDA–2016–N–0001]
IMDRF was organized to provide an SaMD beyond those described in the
opportunity for global harmonization document? Advisory Committee; Antimicrobial
initiatives to be developed with input 6. Are the recommendations Drugs Advisory Committee, Renewal
from both regulatory and industry identified in section 7.2 related to the AGENCY: Food and Drug Administration,
representatives. The current members of ‘‘importance of clinical evidence and HHS.
the Management Committee of the expectations’’ appropriate as outlined
IMDRF are regulatory officials from ACTION:Notice; renewal of advisory
for the different SaMD categories? committee.
Australia (Therapeutic Goods
7. Are the recommendations
Administration), Brazil (National Health SUMMARY: The Food and Drug
identified in section 7.3 related to the
Surveillance Agency), Canada (Health Administration (FDA) is announcing the
‘‘importance of independent review’’
Canada), China (China Food and Drug renewal of the Antimicrobial Drugs
appropriate as outlined for the different
Administration), European Union Advisory Committee by the
SaMD categories?
(European Commission Directorate- Commissioner of Food and Drugs (the
General for Internal Market, Industry, 8. Given the uniqueness of SaMD and
the proposed framework—is there any Commissioner). The Commissioner has
Entrepreneurship and Small and determined that it is in the public
Medium-sized Enterprises), Japan impact on currently regulated devices or
any possible adverse consequences? interest to renew the Antimicrobial
(Pharmaceuticals and Medical Devices Drugs Advisory Committee for an
Agency and the Ministry of Health, The draft guidance and the IMDRF
additional 2 years beyond the charter
Labour and Welfare), Russia (Ministry of comment page are available at http://
expiration date. The new charter will be
Healthcare), and the United States (U.S. www.imdrf.org/consultations/
in effect until October 7, 2018.
FDA). The World Health Organization consultations.asp#current.
DATES: Authority for the Antimicrobial
and the Asia-Pacific Economic II. Significance of Guidance
Cooperation Life Sciences Innovation Drugs Advisory Committee will expire
Forum Regulatory Harmonization This draft guidance is being issued on October 7, 2016, unless the
Steering Committee are Official consistent with FDA’s good guidance Commissioner formally determines that
Observers. The Asian Harmonization practices regulation (21 CFR 10.115). renewal is in the public interest.
Working Party and the Pan American The draft guidance, when finalized, will FOR FURTHER INFORMATION CONTACT:
Health Organization are IMDRF Affiliate represent the current thinking of FDA Lauren Tesh, Center for Drug Evaluation
rmajette on DSK2TPTVN1PROD with NOTICES
Organizations. on ‘‘Software as a Medical Device and Research, Food and Drug
In September 2016, the IMDRF (SaMD): Clinical Evaluation.’’ It does Administration, 10903 New Hampshire
Management Committee endorsed the not establish any rights for any person Ave., Bldg. 31, Rm. 2417, Silver Spring,
draft guidance entitled ‘‘Software as a and is not binding on FDA or the public. MD 20993–0002, 301–796–9001, email:
Medical Device (SaMD): Clinical You can use an alternative approach if AMDAC@fda.hhs.gov.
Evaluation’’ and agreed that the it satisfies the requirements of the SUPPLEMENTARY INFORMATION: Pursuant
guidance should be made available for applicable statutes and regulations. to 41 CFR 102–3.65 and approval by the
VerDate Sep<11>2014 14:29 Oct 13, 2016 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\14OCN1.SGM 14OCN1](https://thefederalregister.org/doc/81_FR_71304/page/2.svg)
Document Created: 2016-10-14 00:01:09
Document Modified: 2016-10-14 00:01:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 71105 |
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