[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50134-50135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1264]


Manufacturers Sharing Patient-Specific Information From Medical 
Devices With Patients Upon Request; 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 guidance entitled ``Manufacturers Sharing 
Patient-Specific Information from Medical Devices with Patients Upon 
Request.'' FDA developed this guidance to clarify our position 
regarding manufacturers appropriately and responsibly sharing 
``patient-specific information''--information unique to an individual 
patient or unique to that patient's treatment or diagnosis that has 
been recorded, stored, processed, retrieved, and/or derived from a 
legally marketed medical device--with that patient at that patient's 
request. This guidance provides information and recommendations to 
industry, health care providers, and FDA staff about the mechanisms and 
considerations for device manufacturers sharing such information with 
individual patients when they request it.

DATES: The announcement of the guidance is published in the Federal 
Register on October 30, 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-2016-D-1264 for ``Manufacturers Sharing Patient-Specific 
Information from Medical Devices with Patients Upon Request.'' 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 guidance document entitled 
``Manufacturers Sharing Patient-Specific Information from Medical 
Devices with Patients Upon Request'' 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. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Esther Bleicher, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-
796-8547.

SUPPLEMENTARY INFORMATION:

I. Background

    Increasingly, patients seek to play an active role in their own 
health care. FDA believes that sharing ``patient-specific information'' 
with patients upon their request may assist them in being more engaged 
with their health care providers in making sound medical decisions. For 
purposes of this guidance, ``patient-specific information'' is 
information unique to an individual

[[Page 50135]]

patient or unique to that patient's treatment or diagnosis that has 
been recorded, stored, processed, retrieved, and/or derived from a 
legally marketed medical device. This information may include, but is 
not limited to, recorded patient data, device usage/output statistics, 
health care provider inputs, incidence of alarms, and/or records of 
device malfunctions or failures.
    FDA developed this guidance to convey FDA's position regarding 
manufacturers appropriately and responsibly sharing patient-specific 
information with that patient at that patient's request. In general, 
manufacturers may do so without undergoing additional premarket review 
in advance. FDA generally would not consider patient-specific 
information to be ``labeling,'' as defined in section 201(m) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(m)). 
FDA is aware that when manufacturers share patient-specific information 
with patients, manufacturers also may provide them with supplemental 
information or other materials (e.g., descriptions of intended use, 
benefit and risk information, instructions for use) that may be 
considered labeling. Any labeling is subject to applicable requirements 
in the FD&C Act and FDA regulations.
    In the Federal Register of June 10, 2016 (81 FR 37603), FDA 
announced the availability of the draft guidance formerly entitled 
``Dissemination of Patient-Specific Information from Devices by Device 
Manufacturers'' and interested parties were invited to comment by 
August 9, 2016. FDA has considered all of 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 ``Manufacturers Sharing Patient-Specific 
Information from Medical Devices with Patients Upon Request.'' 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. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Manufacturers Sharing 
Patient-Specific Information from Medical Devices with Patients Upon 
Request'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1500067 to identify the guidance you are requesting.

    Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23517 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P