Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
| Published date | 29 July 2020 |
| Citation | 85 FR 45640 |
| Record Number | 2020-16394 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 85 Issue 146 (Wednesday, July 29, 2020)
[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.
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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:
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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]
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