[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49375-49377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23197]


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

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 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.

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

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 Change to an Existing Device.'' FDA is issuing this final 
guidance document to clarify when a change in a legally marketed 
medical device would require that a manufacturer submit a premarket 
notification (510(k)) to FDA. This guidance document supersedes 
``Deciding When to Submit a 510(k) for a Change to an Existing 
Device,'' issued January 10, 1997. FDA is correcting an error in the 
docket number assigned to the ``Deciding When to Submit a 510(k) for a 
Change to an Existing Device'' notice of availability when it published 
in the Federal Register (81 FR 52443, August 8, 2016). The docket 
number currently is FDA-2016-D-2021. FDA is changing the docket number 
to FDA-2011-D-0453. 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-2011-D-0453 for ``Deciding When to Submit a 510(k) for a 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.

[[Page 49376]]

     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 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: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; 
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 modify 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 modification exceeds the regulatory threshold of 
Sec.  807.81(a)(3) for submission and clearance of a new 510(k).
    This guidance supersedes the original ``Deciding When to Submit a 
510(k) for a Change to an Existing Device,'' issued on January 10, 
1997. That guidance provided the Agency's interpretation of whether the 
modification exceeds the regulatory threshold of Sec.  807.81(a)(3), 
with principles and points for manufacturers to consider in analyzing 
how changes in devices may affect safety or effectiveness and 
determining whether a new 510(k) must be submitted for a particular 
type of change. This final guidance preserves the basic format and 
content of the original, with updates to add clarity. The added clarity 
is intended to increase consistent interpretations of the guidance by 
FDA staff and manufacturers.
    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 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. The recommendations discussed in this guidance for evaluating 
when a change to an existing device would trigger the requirement that 
a manufacturer submit a new 510(k) to the Agency are consistent with 
least burdensome principles (Refs. 1 and 2). The least burdensome 
provision concerning 510(k)s states that FDA ``shall only request 
information that is necessary . . .'' and ``shall consider the least 
burdensome means of demonstrating substantial equivalence . . .'' (see 
section 513(i)(1)(D)(i) of the FD&C Act). While not changing the 
standard for substantial equivalence, this provision states that FDA 
shall only request the ``minimum required information'' necessary to 
support a determination of substantial equivalence (see sections 
513(i)(1)(D)(ii)-(iii) of the FD&C Act).
    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 Software Change to an Existing Device'' to aid 
manufacturers of medical devices who intend to make software changes to 
an existing device 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).
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of August 8, 2016. FDA revised the 
guidance as appropriate in response to the comments.

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 
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

[[Page 49377]]

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/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Deciding When to Submit a 510(k) for a 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 1500054 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 have been approved under 
OMB control number 0910-0437; and the collections of information in 21 
CFR parts 801 and 809 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. 2017-23197 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P


