Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability, 57919-57921 [2016-20221]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57919-57921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20221]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1580]


Patient Preference Information--Voluntary Submission, Review in 
Premarket Approval Applications, Humanitarian Device Exemption 
Applications, and De Novo Requests, and Inclusion in Decision Summaries 
and Device Labeling; Guidance for Industry, Food and Drug 
Administration Staff and Other Stakeholders; 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 ``Patient Preference 
Information--Voluntary Submission, Review in PMAs, HDE Applications, 
and De Novo Requests, and Inclusion in Decision Summaries and Device 
Labeling.'' This document explains the principal concepts that sponsors 
and other stakeholders should consider when choosing to collect patient 
preference information (PPI), which may inform FDA's benefit-risk 
determinations in the premarket review of premarket approval 
applications (PMAs), humanitarian device exemption (HDE) applications, 
and de novo classification requests. This guidance also discusses FDA's 
inclusion of PPI in its decision summaries and provides recommendations 
for the inclusion of such information in device labeling for certain 
devices. FDA is also issuing a Level 2 updated version of the guidance 
document entitled ``Factors To Consider When Making Benefit-Risk 
Determinations in Medical Device Premarket Approval and De Novo 
Classifications,'' originally issued on March 28, 2012, that has been 
edited to be consistent with this guidance document.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments 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): 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-2015-D-1580 for ``Patient Preference Information--Voluntary 
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Decision Summaries and Device Labeling.'' If you are 
making submissions that also address the edits to the Level 2 guidance, 
the submissions received must include the Docket No. FDA-2011-D-0577 
for ``Factors To Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classifications.'' 
Received comments will be placed in the docket(s) noted and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://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 https://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: https://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 https://www.regulations.gov and insert the

[[Page 57920]]

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 guidance document entitled 
``Patient Preference Information--Voluntary Submission, Review in PMAs, 
HDE Applications, and De Novo Requests, and Inclusion in Decision 
Summaries and Device Labeling'' 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: Anindita Saha, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002, 301-796-2537, 
Anindita.Saha@fda.hhs.gov; 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

    FDA is announcing the availability of a guidance entitled ``Patient 
Preference Information--Voluntary Submission, Review in PMAs, HDE 
Applications, and De Novo Requests, and Inclusion in Decision Summaries 
and Device Labeling.'' FDA believes that patients can and should bring 
their own experiences to bear in helping the Agency to evaluate the 
benefit-risk profiles of certain devices. This kind of input can be 
important to consider during FDA's decisionmaking for these devices.
    This document explains the principal concepts that sponsors and 
other stakeholders should consider when choosing to collect PPI, which 
may inform FDA's benefit-risk determinations in the premarket review of 
PMAs, HDE applications, and de novo requests. This guidance also 
discusses FDA's inclusion of PPI in its decision summaries and provides 
recommendations for the inclusion of such information in device 
labeling for certain devices.
    The objectives of this guidance are: (1) To encourage submission of 
PPI, if available, by sponsors or other stakeholders to FDA and to aid 
in FDA decisionmaking; (2) to outline recommended qualities of patient 
preference studies, which may result in valid scientific evidence; (3) 
to provide recommendations for collecting and submitting PPI to FDA; 
and (4) to discuss FDA's inclusion of PPI in its decision summaries and 
provide recommendations for the inclusion of such information in device 
labeling, where appropriate. The guidance also includes hypothetical 
examples that illustrate how PPI may inform FDA's decisionmaking. The 
guidance applies to both diagnostic and therapeutic devices that are 
subject to these review processes. Additionally, this guidance may be 
information to other stakeholders such as patient groups and academia 
who may wish to conduct patient preference studies.
    In the Federal Register of May 18, 2015 (80 FR 28277), FDA 
announced the availability of the draft of this guidance and interested 
persons were invited to comment by August 17, 2015. FDA has considered 
all of the public comments received in finalizing this guidance.
    FDA is also issuing a Level 2 update to the guidance document 
entitled ``Factors To Consider When Making Benefit-Risk Determinations 
in Medical Device Premarket Approval and De Novo Classifications,'' 
which was originally issued on March 28, 2012, to ensure consistency 
with the terminology and concepts presented in 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 ``Patient Preference Information--Voluntary 
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Decision Summaries and Device Labeling.'' 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 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 ``Patient Preference Information--
Voluntary Submission, Review in PMAs, HDE Applications, and De Novo 
Requests, and Inclusion in Decision Summaries and Device Labeling'' or 
``Factors To Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classifications'' may 
send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number 1500006 
or 1772 respectively to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently 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 812.25(c) have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts B and 
E have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814, subpart H have been 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 822 have been approved under OMB control 
number 0910-0449; the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485; 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.


[[Page 57921]]


    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20221 Filed 8-23-16; 8:45 am]
BILLING CODE 4164-01-P