Document ID: FDA-2014-D-0900-0012
Agency: fda
Document Type: Notice
Title: Benefit-Risk Factors To Consider When Determining Substantial
Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2018-09-25T04:00Z

[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48439-48441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20771]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0900]

Benefit-Risk Factors To Consider When Determining Substantial 
Equivalence in Premarket Notifications (510(k)) With Different 
Technological Characteristics; 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 final guidance entitled ``Benefit-Risk Factors 
to Consider When Determining Substantial Equivalence in Premarket 
Notifications (510(k)) with Different Technological Characteristics.'' 
This guidance document describes factors FDA considers when evaluating 
the benefit-risk profile of a device in comparison to a predicate 
device in a 510(k) when the device has the same intended use as the 
predicate device, and different technological characteristics that do 
not raise different questions of safety and effectiveness. This 
guidance can be helpful in situations when there is an increase in risk 
and increase or equivalent benefit, or a decrease in benefit and a 
decrease or equivalent risk when comparing a new device to a predicate 
device. FDA developed this guidance to improve the predictability, 
consistency, and transparency of the 510(k) premarket review process.

DATES: The announcement of the guidance is published in the Federal 
Register on September 25, 2018.

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-2014-D-0900 for ``Benefit-Risk Factors to Consider When Determining 
Substantial Equivalence in Premarket Notifications (510(k)) with 
Different Technological Characteristics.'' 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

[[Page 48440]]

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 
``Benefit-Risk Factors to Consider When Determining Substantial 
Equivalence in Premarket Notifications (510(k)) with Different 
Technological Characteristics'' 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: Ifeanyi Uwemedimo, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002, 240-
402-5243.

SUPPLEMENTARY INFORMATION: 

I. Background

    Submitters seeking 510(k) submission must demonstrate to FDA that 
the new device is substantially equivalent (SE) to a legally marketed 
predicate device using the criteria identified in section 513(i) of the 
FD&C Act (21 U.S.C. 360c(i)). To find a new device SE to a predicate 
device, FDA must first find that the devices have the same intended 
use. FDA must then determine that the devices have the same 
technological characteristics, or that any differences in technological 
characteristics do not raise different questions of safety and 
effectiveness, and that the new device is as safe and effective as the 
predicate device.
    FDA evaluates differences in technological characteristics between 
the new device and the predicate device to determine their effect on 
substantial equivalence (i.e., whether the new device is as safe and 
effective as the predicate device). Under section 513(a)(2) of the FD&C 
Act, FDA determines the safety and effectiveness of a device by 
weighing any probable benefit to health from the use of the device 
against any probable risk of injury or illness from such use, among 
other relevant factors.
    This guidance document is consistent with FDA guidance entitled 
``The 510(k) Program: Evaluating Substantial Equivalence in Premarket 
Notifications [510(k)]'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443), issued on 
July 28, 2014, and provides additional clarification on factors that 
FDA takes into consideration when evaluating the benefit-risk profile 
of a new device in comparison to a predicate device when FDA must 
evaluate whether the new device is substantially equivalent to the 
predicate device. More specifically, in situations where (1) an 
increase in risk and increase or equivalent benefit or (2) a decrease 
in benefit and a decrease or equivalent risk when comparing a new 
device to a predicate device, FDA recommends that a benefit-risk 
assessment be conducted to provide further perspective regarding 
whether the new device is substantially equivalent to the predicate. 
FDA does not recommend a benefit-risk assessment in situations where 
there is (1) an increase in risk and decrease in benefit or (2) 
decrease or equivalent risk and increase or equivalent benefit because 
benefit-risk factors are not warranted to determine whether a device is 
substantially equivalent. This guidance does not add new regulatory 
requirements for submitters, it does not change the 510(k) premarket 
review standard, nor does it create extra or new burdens on what has 
traditionally been submitted in 510(k)s.
    In the Federal Register on July 15, 2014 (79 FR 41289), FDA 
announced the availability of the draft guidance and interested parties 
were invited to comment by October 14, 2014. FDA has considered all the 
public comments received prior to finalizing this guidance.

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 benefit-risk factors to consider when 
determining substantial equivalence in premarket notifications (510(k)) 
with different technological characteristics. 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. This 
guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Benefit-Risk Factors to Consider When 
Determining Substantial Equivalence in Premarket Notifications (510(k)) 
with Different Technological Characteristics'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1818 to identify the 
guidance you are requesting.

IV. 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. 3501-3520). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 48441]]

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
803...............................  Medical Devices;           0910-0437
                                     Medical Device
                                     Reporting;
                                     Manufacturer
                                     reporting, importer
                                     reporting, user
                                     facility reporting,
                                     distributor
                                     reporting.
------------------------------------------------------------------------

    Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20771 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P