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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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 “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                           ( print 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                     *CDRH-Guidance@fda.hhs.gov*                     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