81 FR 52441 - Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to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. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52441-52443]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18714]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]


Deciding When To Submit a 510(k) for a Software Change to an 
Existing Device; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Deciding When to 
Submit a 510(k) for a Software Change to an Existing Device.'' FDA is 
issuing this draft guidance document to clarify when a software change 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. This draft guidance is 
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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:

[[Page 52442]]

     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2011-D-0453 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 http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 
``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 to 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. 1314, Silver Spring, MD 20993-0002, 301-796-6325, 
[email protected]; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    A premarket notification (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 those that constitute major changes or modifications in 
the intended use of the device (21 CFR 807.81(a)(3)). This guidance, 
when finalized, will aid manufacturers of medical devices who intend to 
make a software modification to a 510(k)-cleared device or a 
preamendments device subject to 510(k) (i.e., ``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).
    This draft guidance specifically addresses software design and 
technology modifications. This draft 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 (see, 
e.g., ``Mobile Medical Applications: Guidance for Industry and FDA 
Staff,'' issued February 9, 2015, available on the Internet at http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf).
    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.  807.81(a)(3) 
for submission and clearance of a new 510(k).

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 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.

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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://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.

[[Page 52443]]

IV. Paperwork Reduction Act of 1995

    This draft 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.

    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18714 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P