[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37603-37604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Dissemination of Patient-Specific Information From Devices by 
Device Manufacturers; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Dissemination of 
Patient-Specific Information from Devices by Device Manufacturers.'' 
The FDA developed this draft guidance to facilitate the appropriate and 
responsible dissemination of patient-specific information recorded, 
stored, processed, retrieved, and/or derived from medical devices from 
manufacturers to patients. This draft guidance provides recommendations 
to industry, healthcare providers, and FDA staff about the mechanisms 
and considerations for device manufacturers sharing such information 
with patients. This draft guidance is not final nor is it in effect at 
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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.''

[[Page 37604]]

    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1264 for ``Dissemination of Patient-Specific Information 
from Devices by Device Manufacturers.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://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 http://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: http://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 http://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 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 draft guidance document entitled 
``Dissemination of Patient-Specific Information from Devices by Device 
Manufacturers'' 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: Sugato De, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Increasingly, patients seek to play an active role in their own 
healthcare. FDA believes that manufacturers providing patients with 
accurate, useable information about their healthcare (including the 
medical products they use and patient-specific information these 
products generate) will improve healthcare by empowering patients to 
participate fully with their healthcare providers in making sound 
medical decisions. For purposes of this guidance, patient-specific 
information is defined as any information unique to an individual 
patient or unique to that patient's treatment or diagnosis that may be 
recorded, stored, processed, retrieved, and/or derived from a medical 
device. This information may include, but is not limited to, recorded 
patient data, device usage/output statistics, healthcare provider 
inputs, incidence of alarms, and/or records of device malfunctions or 
failures.
    FDA developed this draft guidance to convey FDA's policy regarding 
the dissemination of patient-specific information recorded, stored, 
processed, retrieved, and/or derived from a medical device and provided 
by the manufacturer to the patient who is either treated or diagnosed 
with that specific device. This draft guidance document also outlines 
considerations for the form in which this information is communicated 
to help to ensure clarity of content and appropriate context.
    Manufacturers may share patient-specific information (recorded, 
stored, processed, retrieved, and/or derived from a medical device, 
consistent with the intended use of that medical device) with patients 
either on their own initiative or at the patient's request, without 
obtaining additional premarket review before doing so. Any labeling, as 
that term is defined in section 201(m) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), that is provided to the patient by the 
manufacturer is subject to applicable requirements in the FD&C Act and 
FDA regulations.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance when 
finalized will represent the current thinking of FDA on ``Dissemination 
of Patient-Specific Information from Devices by Device Manufacturers.'' 
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 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Dissemination of Patient-
Specific Information from Devices by Device Manufacturers'' 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.

IV. Paperwork Reduction Act of 1995

    This 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 parts 801 and 809, 
regarding device labeling, are approved under OMB control number 0910-
0485.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13787 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P