Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Guidance for Industry and Food and Drug Administration Staff; Availability, 57994-57996 [2017-26441]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 57994 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 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/201523389.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)). Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877–287–1373, email: CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised guidance for industry entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ This VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). We made this determination given the upcoming deadline for product listing information updates for owners and operators of tobacco product manufacturing establishments. In addition, the compliance policy for certain product listing information updates set forth in this revised guidance presents a policy to limit submissions consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA’s GGP regulation. This revised guidance describes the compliance policy for product listing information updates for deemed tobacco products for persons who owned or operated domestic manufacturing establishments engaged in the manufacture of deemed products prior to August 8, 2016, and continued to own or operate such establishment(s) on or after August 8, 2016. With respect to the deemed tobacco products listing requirement, FDA does not intend to enforce the requirement for persons who own or operate domestic manufacturing establishments engaged in the manufacture of deemed tobacco products to update product listing information during the month of December 2017 provided they registered and listed their products by October 12, 2017.1 As a result, registrants of deemed products would update their product listing by June 30, 2018, and complete their next annual registration by December 31, 2018. If an establishment is engaged in the manufacture of both deemed tobacco products and tobacco products originally regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA intends to enforce the registration and product listing information requirements for tobacco products originally regulated under the FD&C Act. Owners or operators of establishments engaged in the manufacture of deemed products as of August 8, 2016, were first required to register and submit deemed product listing information under 1 Registration by such persons by October 12, 2017, satisfies the requirement in section 905(b) of the FD&C Act that such persons register their establishments annually on or before December 31, 2017. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 section 905 of the FD&C Act (21 U.S.C. 387e) by December 31, 2016. However, in a guidance issued in September 2017, FDA announced that it does not intend to enforce these requirements with respect to deemed products provided the registration and product listing submissions were received by FDA on or before October 12, 2017. 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 registration and product listing for owners and operators of domestic tobacco product establishments. 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in section 905 of the FD&C Act have been approved under OMB control number 0910–0650. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26469 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P 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. E:\FR\FM\08DEN1.SGM 08DEN1 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices ACTION: Notice of availability. 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: sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: 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: VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 • 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/201523389.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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 57995 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 selfaddressed 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 DirectorateGeneral 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 E:\FR\FM\08DEN1.SGM 08DEN1 sradovich on DSK3GMQ082PROD with NOTICES 57996 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 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 VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 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 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: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–3083] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993–0002, 301– 796–0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background A. Postmarketing Requirements and Commitments A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A PMC is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation. PMRs and PMCs can be issued upon approval of a drug 1 or postapproval, if warranted. FDA can require application holders to conduct postmarketing studies and clinical trials: • To assess a known serious risk, assess signals of serious risk, or identify an unexpected serious risk related to the use of a drug product (section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)), as added by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110–85)). • Under the Pediatric Research Equity Act (PREA) (Pub. L. 108–155), to study certain new drugs for pediatric populations, when these drugs are not adequately labeled for children. Under section 505B(a)(3) of the FD&C Act (21 U.S.C. 355c), the initiation of these studies may be deferred until required safety information from other studies in adults has first been submitted and reviewed. • To verify and describe the predicted effect or other clinical benefit for drugs approved in accordance with the accelerated approval provisions in section 506(c)(2)(A) of the FD&C Act (21 SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 1 For the purposes of this notice, references to ‘‘drugs’’ or ‘‘drug products’’ include drugs approved under the FD&C Act and biological products licensed under the Public Health Service Act other than biological products that also meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[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]


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

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.

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

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

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