[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45640-45642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1339]


Multiple Function Device Products: Policy and Considerations; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Multiple Function 
Device Products: Policy and Considerations; Guidance for Industry and 
Food and Drug Administration Staff.'' This final guidance provides 
FDA's regulatory approach for device products with multiple functions 
including at least one device function and includes such device 
products that are part of combination products, in accordance with the 
21st Century Cures Act (Cures Act).

DATES: The announcement of the guidance is published in the Federal 
Register on July 29, 2020.

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

[[Page 45641]]

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-2018-D-1339 for ``Multiple Function Device Products: Policy and 
Considerations; Guidance for Industry and Food and Drug Administration 
Staff.'' 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, 240-402-7500.
     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.govinfo.gov/content/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 
``Multiple Function Device Products: Policy and Considerations; 
Guidance for Industry and Food and Drug Administration Staff'' to the 
Office of Policy, 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; or 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; 
or the Center for Drug Evaluation and Research, Food and Drug 
Administration, 10001 New Hampshire Ave., Hillandale Building, 4th 
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: 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; 
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, 240-402-7911; or Kristina Lauritsen, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993-0002, 
301-796-8936.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 13, 2016, the Cures Act (Pub. L. 114-255) was signed 
into law. Section 3060(a) of this legislation entitled ``Clarifying 
Medical Software Regulation'' amended the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) to add section 520(o) (21 U.S.C. 360j(o)), 
which excludes certain software functions from the definition of device 
in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). In addition, 
section 520(o)(2) of the FD&C Act describes the regulation and 
assessment of a product with multiple functions including at least one 
device function and at least one software function that is not a 
device. Although section 520(o)(2) of the FD&C Act applies to the 
regulation of software products containing at least one device function 
and at least one non-device software function, FDA believes that a 
similar approach should be used for the assessment of all multiple 
function device products that contain at least one device function and 
one ``other function'', which may be a non-device software function; a 
function that meets the definition of a device, but is not subject to 
premarket review; or a function that meets the definition of device, 
but for which FDA has expressed its intention not to enforce compliance 
with applicable regulatory controls. This approach also applies to 
multiple function device products that are device constituent parts of 
combination products. FDA considered comments received on the draft 
guidance that appeared in the Federal Register of April 27, 2018 (83 FR 
18570). FDA revised the guidance as appropriate in response to the 
comments.
    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 ``Multiple Function Device Products: Policy 
and Considerations; Guidance for Industry and Food and Drug 
Administration Staff.'' 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.

[[Page 45642]]

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov. Persons unable to 
download an electronic copy of ``Multiple Function Device Products: 
Policy and Considerations; Guidance for Industry and Food and Drug 
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 17038 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information have 
been approved by OMB as follows:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
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803............................  Medical device                0910-0437
                                  reporting.
807, subparts A through D......  Registration and              0910-0625
                                  listing.
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational device        0910-0078
                                  exemption.
814, subparts A through E......  Premarket approval            0910-0231
                                  applications.
814, subpart H.................  Humanitarian use              0910-0332
                                  devices.
820............................  Current good                  0910-0073
                                  manufacturing practice
                                  and the quality system
                                  regulation.
312............................  Investigational New           0910-0014
                                  Drug Regulations.
314............................  Applications for FDA          0910-0001
                                  Approval to Market a
                                  New Drug.
314............................  Abbreviated New Drug          0910-0786
                                  Applications and
                                  505(b)(2) Applications.
601; Form FDA 356h.............  Biologics License;            0910-0338
                                  Application to Market
                                  a New Drug or
                                  Abbreviated New Drug
                                  or Biologic for Human
                                  Use--Form FDA 356h.
``User Fees for 513(g) Requests  513(g) requests........       0910-0705
 for Information'' and ``FDA
 and Industry Procedures for
 Section 513(g) Requests for
 Information under the Federal
 Food, Drug, and Cosmetic Act``.
``De Novo Classification         De Novo requests.......       0910-0844
 Process (Evaluation of
 Automatic Class III
 Designation)``.
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    Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16394 Filed 7-28-20; 8:45 am]
BILLING CODE 4164-01-P