[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15847-15848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07564]



[[Page 15847]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1387]


Expansion of the Abbreviated 510(k) Program: Demonstrating 
Substantial Equivalence Through Performance Criteria; Draft Guidance 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the availability of the draft guidance entitled ``Expansion of the 
Abbreviated 510(k) Program: Demonstrating Substantial Equivalence 
Through Performance Criteria; Draft Guidance for Industry and Food and 
Drug Administration Staff.'' This draft guidance provides FDA's current 
thinking on expanding the abbreviated 510(k) program for demonstrating 
substantial equivalence for premarket notification (510(k)) 
submissions. The intent of the draft guidance is to describe an 
optional program for certain well understood device types, where a 
submitter could demonstrate that a new device meets FDA-identified 
performance criteria instead of directly comparing the performance of 
the new device to a specific, submitter-identified predicate device as 
part of a demonstration of substantial equivalence. This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by July 11, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1387 for ``Expansion of the Abbreviated 510(k) Program: 
Demonstrating Substantial Equivalence Through Performance Criteria; 
Draft 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.
     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 
``Expansion of the Abbreviated 510(k) Program: Demonstrating 
Substantial Equivalence Through Performance Criteria; Draft Guidance 
for Industry and Food and Drug Administration Staff'' 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: 
    For Center for Devices and Radiological Health-regulated devices: 
Sonja Fulmer, Office of the Center Director, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5421, Silver 
Spring, MD 20993-0002, 301-402-5979.
    For Center for Biologics Evaluation and Research-regulated devices: 
Stephen Ripley, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

[[Page 15848]]


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has explained and clarified, through the guidance entitled, 
``The 510(k) Program: Evaluating Substantial Equivalence in Premarket 
Notifications [510(k)]'' (Ref. 1), how it makes substantial equivalence 
decisions under section 513(i)(1)(A) of the Federal, Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(i)(1)(A)). Substantial 
equivalence is rooted in comparisons between new devices and predicate 
devices. However, the FD&C Act does not preclude FDA from using 
performance criteria to facilitate this comparison. If a legally 
marketed device performs at certain levels relevant to its safety and 
effectiveness, and a new device meets or exceeds those levels of 
performance for the same characteristics, FDA could find the new device 
as safe and effective as the legally marketed device. Instead of 
reviewing data from direct comparison testing between the two devices, 
FDA could support a finding of substantial equivalence with data 
showing the new device meets or exceeds the level of performance of 
appropriate predicate device(s). Under the approach expanded in this 
guidance, a submitter could satisfy the requirement to compare its 
device with a legally marketed device by, among other things, 
demonstrating conformance to performance criteria established in FDA-
recognized consensus standards, FDA guidance, and/or special controls.
    Use of this approach may also streamline the review of 510(k) 
submissions, thereby reducing burdens on the Agency and possibly review 
times on individual submissions. In addition, this approach may 
facilitate healthcare professionals and patients making better informed 
decisions, by helping ensure a device cleared through this pathway 
meets a transparent set of performance criteria. At the same time, this 
approach satisfies the statutory standard for demonstrating substantial 
equivalence. As a result, this expanded approach is intended to promote 
the public health by helping patients gain more timely access to new 
medical devices that are high quality, safe, and effective. FDA 
welcomes public input on device types for which FDA should consider 
identifying performance criteria and evidence-based suggestions on what 
the performance criteria should be.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (Sec.  10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Expansion of 
the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence 
Through Performance Criteria; Draft 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. 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 draft 
guidance document is also available at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Expansion of the Abbreviated 510(k) Program: 
Demonstrating Substantial Equivalence Through Performance Criteria; 
Draft 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.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance. 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 807, subpart E have 
been approved under OMB control number 0910-0120 and the collections of 
information in the guidance document ``Requests for Feedback on Medical 
Device Submissions: The Pre-Submission Program and Meetings with Food 
and Drug Administration Staff'' have been approved under OMB control 
number 0910-0756.

V. Reference

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

1. ``The 510(k) Program: Evaluating Substantial Equivalence in 
Premarket Notifications [510(k)]--Guidance for Industry and Food and 
Drug Administration Staff,'' July 28, 2014, available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.

    Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07564 Filed 4-11-18; 8:45 am]
 BILLING CODE 4164-01-P


