[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49382-49384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2021]


Deciding When To Submit a 510(k) for a Software Change to an 
Existing Device; 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 guidance entitled ``Deciding When to Submit a 
510(k) for a Software Change

[[Page 49383]]

to an Existing Device.'' FDA is issuing this final guidance document to 
clarify when a software change in a legally marketed medical device 
would require that a manufacturer submit a premarket notification 
(510(k)) to FDA. FDA is correcting an error in the docket number 
assigned to the ``Deciding When to Submit a 510(k) for a Software 
Change to an Existing Device'' notice of availability when it published 
in the Federal Register (81 FR 52441, August 8, 2016). The docket 
number currently is FDA-2011-D-0453. FDA is changing the docket number 
to FDA-2016-D-2021. This action is administrative in nature and is 
being taken to avoid any potential confusion in the docket.

DATES: The announcement of the guidance is published in the Federal 
Register on October 25, 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-2021 for ``Deciding When to Submit a 510(k) for a Software 
Change to an Existing Device.'' 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 
``Deciding When to Submit a 510(k) for a Software Change to an Existing 
Device'' 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 
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: Linda Ricci, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G634, Silver Spring, MD 20993-0002, 301-796-6325, 
[email protected]; and 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 510(k) is required when a legally marketed device subject to 
510(k) requirements is about to be significantly changed or modified in 
design, components, method of manufacture, or intended use. Significant 
changes or modifications are those that could significantly affect the 
safety or effectiveness of the device, or major changes or 
modifications in the intended use of the device (Sec.  807.81(a)(3) (21 
CFR 807.81(a)(3)). This guidance will aid manufacturers of medical 
devices who intend to make a software modification to a 510(k)-cleared 
device or other device subject to 510(k) requirements, such as a 
preamendments device or a device that was granted marketing 
authorization via the De Novo classification process under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 360c(f)(2)) (also referred to together as ``existing 
devices''), during the process of deciding whether the software 
modification exceeds the regulatory threshold of Sec.  807.81(a)(3) for 
submission and clearance of a new 510(k).

[[Page 49384]]

    This guidance specifically addresses software design and technology 
modifications, including firmware. This guidance does not apply to 
software for which the Agency has stated in guidance that it does not 
intend to enforce compliance with applicable regulatory controls (e.g., 
``Mobile Medical Applications: Guidance for Industry and FDA Staff,'' 
issued February 9, 2015, available on the internet at https://www.fda.gov/downloads/medicaldevices/.../ucm263366.pdf) and software 
that does not meet the definition of a medical device at section 201(h) 
of the FD&C Act (21 U.S.C. 321(h)).
    In the Federal Register on August 8, 2016, FDA announced the 
availability of the draft guidance and interested parties were 
requested to comment by November 7, 2016. FDA considered comments 
received on the draft guidance and revised the guidance as appropriate.
    This guidance is not intended to implement significant policy 
changes to FDA's current thinking on when submission of a new 510(k) is 
required for a software change to an existing device. Rather, the 
intent of this guidance is to enhance the predictability, consistency, 
and transparency of the ``when to submit'' decision-making process by 
providing a least burdensome approach, and describing in greater detail 
the regulatory framework, policies, and practices underlying such a 
decision, specifically as it relates to software changes. The 
recommendations discussed in this guidance for evaluating when a 
software change to an existing device would trigger the requirement 
that a manufacturer submit a new 510(k) to the Agency are consistent 
with the least burdensome principles (Refs. 1 and 2). This guidance 
applies the least burdensome principles, in part, by reliance on risk 
management and the quality system regulation (21 CFR part 820) to 
determine whether submission of a new 510(k) is required for a software 
change to an existing device.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the guidance document entitled ``Deciding When to 
Submit a 510(k) for a Change to an Existing Device,'' to aid 
manufacturers of medical devices who intend to make non-software 
changes to an existing device during the process of deciding whether 
the modification exceeds the regulatory threshold of Sec.  
[thinsp]807.81(a)(3) for submission and clearance of a new 510(k).

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 ``Deciding When to Submit a 510(k) for a 
Software Change to an Existing Device.'' 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. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to 
download an electronic copy of ``Deciding When to Submit a 510(k) for a 
Software Change to an Existing Device'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1500055 to identify the 
guidance you are requesting.

IV. 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 21 CFR part 820 are approved under OMB 
control number 0910-0073; the collections of information in 21 CFR part 
807, subpart E are approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 803 are approved under OMB 
control number 0910-0437; and the collections of information in 21 CFR 
parts 801 are approved under OMB control number 0910-0485.

V. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. ``The Least Burdensome Provisions of the FDA Modernization Act of 
1997: Concept and Principles,'' dated October 4, 2002, available at: 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf.
2. ``Suggested Format for Developing and Responding to Deficiencies 
in Accordance with the Least Burdensome Provisions of FDAMA,'' dated 
November 2, 2000, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073680.pdf.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23196 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P


