82 FR 57994 - Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 57994-57996 | |
| FR Document | 2017-26441 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 57994-57996] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![57994 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
the claimed confidential information, in guidance is intended to assist persons section 905 of the FD&C Act (21 U.S.C.
its consideration of comments. The making tobacco product establishment 387e) by December 31, 2016. However,
second copy, which will have the registration and product listing in a guidance issued in September 2017,
claimed confidential information submissions to FDA. We are issuing this FDA announced that it does not intend
redacted/blacked out, will be available guidance consistent with our good to enforce these requirements with
for public viewing and posted on guidance practices (GGP) regulation respect to deemed products provided
https://www.regulations.gov. Submit (§ 10.115 (21 CFR 10.115)). We are the registration and product listing
both copies to the Dockets Management implementing this guidance without submissions were received by FDA on
Staff. If you do not wish your name and prior public comment because we have or before October 12, 2017.
contact information to be made publicly determined that prior public
participation is not feasible or II. Significance of Guidance
available, you can provide this
information on the cover sheet and not appropriate (§ 10.115(g)(2)). We made This guidance is being issued
in the body of your comments and you this determination given the upcoming consistent with FDA’s good guidance
must identify this information as deadline for product listing information practices regulation (21 CFR 10.115).
‘‘confidential.’’ Any information marked updates for owners and operators of The guidance represents the current
as ‘‘confidential’’ will not be disclosed tobacco product manufacturing thinking of FDA on registration and
except in accordance with 21 CFR 10.20 establishments. In addition, the product listing for owners and operators
and other applicable disclosure law. For compliance policy for certain product of domestic tobacco product
more information about FDA’s posting listing information updates set forth in establishments. It does not establish any
of comments to public dockets, see 80 this revised guidance presents a policy rights for any person and is not binding
FR 56469, September 18, 2015, or access to limit submissions consistent with the on FDA or the public. You can use an
the information at: https://www.gpo.gov/ public health. Although this guidance alternative approach if it satisfies the
fdsys/pkg/FR-2015-09-18/pdf/2015- document is immediately in effect, it requirements of the applicable statutes
23389.pdf. remains subject to comment in and regulations. This guidance is not
Docket: For access to the docket to accordance with FDA’s GGP regulation. subject to Executive Order 12866.
read background documents or the This revised guidance describes the
compliance policy for product listing III. Paperwork Reduction Act of 1995
electronic and written/paper comments
received, go to https:// information updates for deemed tobacco This guidance refers to previously
www.regulations.gov and insert the products for persons who owned or approved collections of information
docket number, found in brackets in the operated domestic manufacturing found in FDA regulations. These
heading of this document, into the establishments engaged in the collections of information are subject to
‘‘Search’’ box and follow the prompts manufacture of deemed products prior review by the Office of Management and
and/or go to the Dockets Management to August 8, 2016, and continued to Budget (OMB) under the Paperwork
Staff, 5630 Fishers Lane, Rm. 1061, own or operate such establishment(s) on Reduction Act of 1995 (44 U.S.C. 3501–
Rockville, MD 20852. or after August 8, 2016. With respect to 3520). The collections of information in
You may submit comments on any the deemed tobacco products listing section 905 of the FD&C Act have been
guidance at any time (see 21 CFR requirement, FDA does not intend to approved under OMB control number
10.115(g)(5)). enforce the requirement for persons who 0910–0650.
Submit written requests for single own or operate domestic manufacturing
establishments engaged in the IV. Electronic Access
copies of this guidance to the Center for
Tobacco Products, Food and Drug manufacture of deemed tobacco Persons with access to the internet
Administration, Document Control products to update product listing may obtain an electronic version of the
Center, 10903 New Hampshire Ave., information during the month of guidance at either https://
Bldg. 71, Rm. G335, Silver Spring, MD December 2017 provided they registered www.regulations.gov or https://
20993–0002. Send one self-addressed and listed their products by October 12, www.fda.gov/TobaccoProducts/
2017.1 As a result, registrants of deemed Labeling/RulesRegulationsGuidance/
adhesive label to assist that office in
products would update their product default.htm.
processing your request or include a Fax
listing by June 30, 2018, and complete
number to which the guidance Dated: December 4, 2017.
their next annual registration by
document may be sent. See the Leslie Kux,
December 31, 2018. If an establishment
SUPPLEMENTARY INFORMATION section for Associate Commissioner for Policy.
is engaged in the manufacture of both
information on electronic access to the
deemed tobacco products and tobacco [FR Doc. 2017–26469 Filed 12–7–17; 8:45 am]
guidance.
products originally regulated under the BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Federal Food, Drug, and Cosmetic Act
Matthew Brenner, Center for Tobacco (the FD&C Act), FDA intends to enforce
Products, Food and Drug the registration and product listing DEPARTMENT OF HEALTH AND
Administration, Document Control information requirements for tobacco HUMAN SERVICES
Center, 10903 New Hampshire Ave., products originally regulated under the
Bldg. 71, Rm. G335, Silver Spring, MD FD&C Act. Food and Drug Administration
20993–0002, 1–877–287–1373, email: Owners or operators of establishments
CTPRegulations@fda.hhs.gov. [Docket No. FDA–2016–D–2483]
engaged in the manufacture of deemed
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION: products as of August 8, 2016, were first Software as a Medical Device: Clinical
required to register and submit deemed Evaluation; International Medical
I. Background product listing information under Device Regulators Forum; Guidance
FDA is announcing the availability of for Industry and Food and Drug
a revised guidance for industry entitled 1 Registration by such persons by October 12,
Administration Staff; Availability
‘‘Registration and Product Listing for 2017, satisfies the requirement in section 905(b) of
the FD&C Act that such persons register their
Owners and Operators of Domestic establishments annually on or before December 31, AGENCY: Food and Drug Administration,
Tobacco Product Establishments.’’ This 2017. HHS.
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![57996 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
Sciences Authority), and the United document, please see https:// commitments (PMCs) required of, or
States (U.S. FDA). The World Health www.fda.gov/MedicalDevices/ agreed upon by, holders of approved
Organization and the Asia-Pacific InternationalPrograms/IMDRF/ drug and biological products. This
Economic Cooperation Life Sciences default.htm. notice is the Agency’s report on the
Innovation Forum Regulatory status of the studies and clinical trials
II. Significance of Guidance
Harmonization Steering Committee are that applicants have agreed to, or are
IMDRF Official Observers. The Asian This guidance is being issued required to, conduct.
Harmonization Working Party and the consistent with FDA’s good guidance
FOR FURTHER INFORMATION CONTACT:
Pan American Health Organization are practices regulation (21 CFR 10.115).
Cathryn C. Lee, Center for Drug
IMDRF Affiliate Organizations. The guidance represents the current
thinking of FDA on ‘‘Software as a Evaluation and Research, Food and
The IMDRF Management Committee Drug Administration, 10903 New
(IMDRF MC) chartered the SaMD Medical Device (SaMD): Clinical
Evaluation.’’ It does not establish any Hampshire Ave., Bldg. 22, Rm. 6484,
Working Group (WG) to develop a
rights for any person and is not binding Silver Spring, MD 20993–0002, 301–
regulatory framework for SaMD and to
on FDA or the public. You can use an 796–0700; or Stephen Ripley, Center for
develop converged principles for global
alternative approach if it satisfies the Biologics Evaluation and Research,
regulators to adopt in their respective
requirements of the applicable statutes Food and Drug Administration, 10903
jurisdictions. The SaMD WG includes
and regulations. This guidance is not New Hampshire Ave., Bldg. 71, Rm.
representatives from the IMDRF
subject to Executive Order 12866. 7301, Silver Spring, MD 20993–0002,
members, industry, academia, and other
240–402–7911.
key stakeholders as well as regional III. Electronic Access
harmonization initiatives from around SUPPLEMENTARY INFORMATION:
the world. Persons interested in obtaining a copy
of the guidance may do so by I. Background
The IMDRF SaMD WG considered
comments received on the draft downloading an electronic copy from A. Postmarketing Requirements and
guidance that was announced in the the Internet. A search capability for all Commitments
Federal Register of October 14, 2016 (81 Center for Devices and Radiological
A PMR is a study or clinical trial that
FR 71105). The SaMD WG also Health guidance documents is available
an applicant is required by statute or
considered public comments received at https://www.fda.gov/MedicalDevices/
regulation to conduct postapproval. A
by other regulators and from other DeviceRegulationandGuidance/
PMC is a study or clinical trial that an
global stakeholders. The final IMDRF/ GuidanceDocuments/default.htm. This
applicant agrees in writing to conduct
SaMD WG/N41 document, ‘‘Software as guidance document is also available at
postapproval, but that is not required by
a Medical Device (SaMD): Clinical https://www.regulations.gov. Persons
statute or regulation. PMRs and PMCs
Evaluation,’’ submitted to IMDRF MC unable to download an electronic copy
can be issued upon approval of a drug 1
was revised appropriately in response to of ‘‘Software as a Medical Device
or postapproval, if warranted.
all of the comments. The IMDRF MC in (SaMD): Clinical Evaluation’’ may send
Ottawa, Canada, at the 12th meeting an email request to CDRH-Guidance@ FDA can require application holders
held from September 19 to 21, 2017, fda.hhs.gov to receive an electronic to conduct postmarketing studies and
unanimously approved the document copy of the document. Please use the clinical trials:
entitled ‘‘Software as a Medical Device document number 16039 to identify the • To assess a known serious risk,
(SaMD): Clinical Evaluation.’’ This final guidance you are requesting. assess signals of serious risk, or identify
IMDRF/SaMD WG/N41 document is an unexpected serious risk related to the
Dated: December 4, 2017. use of a drug product (section 505(o)(3)
available for regulatory implementation Leslie Kux,
according to the regulatory process in of the FD&C Act (21 U.S.C. 355(o)(3)), as
Associate Commissioner for Policy. added by the Food and Drug
each jurisdiction.
This guidance adopts the [FR Doc. 2017–26441 Filed 12–7–17; 8:45 am] Administration Amendments Act of
internationally converged principles BILLING CODE 4164–01–P 2007 (FDAAA) (Pub. L. 110–85)).
agreed upon by the IMDRF. FDA • Under the Pediatric Research Equity
adoption of these principles provides Act (PREA) (Pub. L. 108–155), to study
FDA with an initial framework when DEPARTMENT OF HEALTH AND certain new drugs for pediatric
further developing the Agency’s specific HUMAN SERVICES populations, when these drugs are not
regulatory approaches and expectations adequately labeled for children. Under
Food and Drug Administration
for regulatory oversight. This guidance section 505B(a)(3) of the FD&C Act (21
does not provide recommendations for [Docket No. FDA–2016–N–3083] U.S.C. 355c), the initiation of these
FDA Staff and Industry to apply to studies may be deferred until required
specific regulatory situations, nor does Report on the Performance of Drug safety information from other studies in
it modify current regulatory and Biologics Firms in Conducting adults has first been submitted and
expectations, including those for Postmarketing Requirements and reviewed.
regulatory submissions, at this time. Commitments; Availability • To verify and describe the predicted
FDA intends to consider the principles AGENCY: Food and Drug Administration, effect or other clinical benefit for drugs
of this guidance in the development of HHS. approved in accordance with the
regulatory approaches for SaMD and ACTION: Notice of availability. accelerated approval provisions in
digital health technologies. In
sradovich on DSK3GMQ082PROD with NOTICES
section 506(c)(2)(A) of the FD&C Act (21
developing regulatory approaches based SUMMARY: Under the Federal Food,
on the principles of this guidance, the Drug, and Cosmetic Act (the FD&C Act), 1 For the purposes of this notice, references to
Agency intends to follow a public the Food and Drug Administration (FDA ‘‘drugs’’ or ‘‘drug products’’ include drugs approved
process, including providing or Agency) is required to report under the FD&C Act and biological products
licensed under the Public Health Service Act other
opportunities for public input. For more annually in the Federal Register on the than biological products that also meet the
information on FDA adoption of IMDRF status of postmarketing requirements definition of a device in section 201(h) of the FD&C
documents as an FDA guidance (PMRs) and postmarketing Act (21 U.S.C. 321(h)).
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Document Created: 2017-12-08 01:43:44
Document Modified: 2017-12-08 01:43:44
| 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 | The announcement of the guidance is published in the Federal Register on December 8, 2017. | |
| 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. | |
| FR Citation | 82 FR 57994 |
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