[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18570-18571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08858]


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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; 
Draft Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Multiple Function 
Device Products: Policy and Considerations.'' This draft guidance 
provides FDA's regulatory approach for products with multiple 
functions, including at least one device function, in accordance with 
the 21st Century Cures Act (Cures Act). This draft guidance is not 
final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by June 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-1339 for ``Multiple Function Device Products: Policy and 
Considerations; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability.'' 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 draft guidance document entitled 
``Multiple Function Device Products: Policy and Considerations'' 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, or the Office of Communication, Outreach, and

[[Page 18571]]

Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
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 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 13, 2016, the Cures Act 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 describes 
software functions that are excluded from the definition of the term 
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 software product with multiple functions, including 
at least one device function and at least one software function that is 
not a device. In this draft guidance, FDA provides its current thinking 
on the regulation of products with multiple functions with at least one 
device function. 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 function, FDA believes the same 
principles apply to all multiple function products that contain at 
least one device function.

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 ``Multiple 
Function Device Products: Policy and Considerations.'' 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Multiple Function Device Products: Policy and 
Considerations'' 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.

IV. 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. 3501-3520). The collections of information have 
been approved by OMB as follows:

 
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The collections of information in this 21 CFR part or                                       Have been approved
                  guidance document:                         Regarding this topic:        under OMB control No.:
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803..................................................  Medical device reporting........                0910-0437
807, subparts A-D....................................  Registration and listing........                0910-0625
807, subpart E.......................................  Premarket notification..........                0910-0120
812..................................................  Investigational device exemption                0910-0078
814, subparts A-E....................................  Premarket approval applications.                0910-0231
814, subpart H.......................................  Humanitarian use devices........                0910-0332
820..................................................  Current good manufacturing                      0910-0073
                                                        practice and the quality system
                                                        regulation.
601..................................................  Biologics license applications..                0910-0338
``User Fees for 513(g) Requests for Information'' and  513(g) requests.................                0910-0705
 ``FDA and Industry Procedures for Section 513(g)
 Requests for Information under the Federal Food,
 Drug, and Cosmetic Act''.
``Requests for Feedback on Medical Device              Q-submissions and presubmissions                0910-0756
 Submissions: The Pre-Submission Program and Meetings
 with Food and Drug Administration Staff''.
``De Novo Classification Process (Evaluation of        De Novo requests................                0910-0844
 Automatic Class III Designation)''.
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    Dated: April 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08858 Filed 4-26-18; 8:45 am]
 BILLING CODE 4164-01-P