82 FR 50134 - Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50134-50135 | |
| FR Document | 2017-23517 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Notices] [Pages 50134-50135] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23517] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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 CDRH-Guid[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
![50134 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
Desk Officer for the Administration for solely responsible for ensuring that your Staff. If you do not wish your name and
Children and Families. comment does not include any contact information to be made publicly
confidential information that you or a available, you can provide this
Bob Sargis,
third party may not wish to be posted, information on the cover sheet and not
Reports Clearance Officer. such as medical information, your or in the body of your comments and you
[FR Doc. 2017–23467 Filed 10–27–17; 8:45 am] anyone else’s Social Security number, or must identify this information as
BILLING CODE 4184–01–P confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
that if you include your name, contact except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND information, or other information that and other applicable disclosure law. For
HUMAN SERVICES identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
Food and Drug Administration posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
[Docket No. FDA–2016–D–1264] • If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Manufacturers Sharing Patient-Specific do not wish to be made available to the 23389.pdf.
Information From Medical Devices public, submit the comment as a Docket: For access to the docket to
With Patients Upon Request; Guidance written/paper submission and in the read background documents or the
for Industry and Food and Drug manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Administration Staff; Availability Submissions’’ and ‘‘Instructions’’). received, go to https://
AGENCY: Food and Drug Administration, Written/Paper Submissions www.regulations.gov and insert the
HHS. docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
ACTION: Notice of availability. follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug and/or go to the Dockets Management
written/paper submissions): Dockets
Administration (FDA or Agency) is Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
announcing the availability of the Rockville, MD 20852.
Drug Administration, 5630 Fishers
guidance entitled ‘‘Manufacturers You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Sharing Patient-Specific Information • For written/paper comments guidance at any time (see 21 CFR
from Medical Devices with Patients submitted to the Dockets Management 10.115(g)(5)).
Upon Request.’’ FDA developed this Staff, FDA will post your comment, as An electronic copy of the guidance
guidance to clarify our position well as any attachments, except for document is available for download
regarding manufacturers appropriately information submitted, marked and from the internet. See the
and responsibly sharing ‘‘patient- SUPPLEMENTARY INFORMATION section for
identified, as confidential, if submitted
specific information’’—information as detailed in ‘‘Instructions.’’ information on electronic access to the
unique to an individual patient or Instructions: All submissions received guidance. Submit written requests for a
unique to that patient’s treatment or must include the Docket No. FDA– single hard copy of the guidance
diagnosis that has been recorded, stored, 2016–D–1264 for ‘‘Manufacturers document entitled ‘‘Manufacturers
processed, retrieved, and/or derived Sharing Patient-Specific Information Sharing Patient-Specific Information
from a legally marketed medical from Medical Devices with Patients from Medical Devices with Patients
device—with that patient at that Upon Request.’’ Received comments Upon Request’’ to the Office of the
patient’s request. This guidance will be placed in the docket and, except Center Director, Guidance and Policy
provides information and for those submitted as ‘‘Confidential Development, Center for Devices and
recommendations to industry, health Submissions,’’ publicly viewable at Radiological Health, Food and Drug
care providers, and FDA staff about the https://www.regulations.gov or at the Administration, 10903 New Hampshire
mechanisms and considerations for Dockets Management Staff between 9 Ave., Bldg. 66, Rm. 5431, Silver Spring,
device manufacturers sharing such a.m. and 4 p.m., Monday through MD 20993–0002. Send one self-
information with individual patients Friday. addressed adhesive label to assist that
when they request it. • Confidential Submissions—To office in processing your request.
DATES: The announcement of the submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
guidance is published in the Federal information that you do not wish to be Esther Bleicher, Center for Devices and
Register on October 30, 2017. made publicly available, submit your Radiological Health, Food and Drug
ADDRESSES: You may submit either comments only as a written/paper Administration, 10903 New Hampshire
electronic or written comments on submission. You should submit two Ave., Bldg. 66, Rm. 5424, Silver Spring,
Agency guidances at any time as copies total. One copy will include the MD 20993–0002, 301–796–8547.
follows: information you claim to be confidential SUPPLEMENTARY INFORMATION:
with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS I. Background
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Increasingly, patients seek to play an
following way: Agency will review this copy, including active role in their own health care.
• Federal eRulemaking Portal: the claimed confidential information, in FDA believes that sharing ‘‘patient-
sradovich on DSK3GMQ082PROD with NOTICES
https://www.regulations.gov. Follow the its consideration of comments. The specific information’’ with patients
instructions for submitting comments. second copy, which will have the upon their request may assist them in
Comments submitted electronically, claimed confidential information being more engaged with their health
including attachments, to https:// redacted/blacked out, will be available care providers in making sound medical
www.regulations.gov will be posted to for public viewing and posted on decisions. For purposes of this
the docket unchanged. Because your https://www.regulations.gov. Submit guidance, ‘‘patient-specific information’’
comment will be made public, you are both copies to the Dockets Management is information unique to an individual
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![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50135
patient or unique to that patient’s at https://www.fda.gov/MedicalDevices/ ADDRESSES: You may submit comments
treatment or diagnosis that has been DeviceRegulationandGuidance/ on any guidance at any time as follows:
recorded, stored, processed, retrieved, GuidanceDocuments/default.htm.
Electronic Submissions
and/or derived from a legally marketed Guidance documents are also available
medical device. This information may at https://www.regulations.gov. Persons Submit electronic comments in the
include, but is not limited to, recorded unable to download an electronic copy following way:
patient data, device usage/output of ‘‘Manufacturers Sharing Patient- • Federal eRulemaking Portal:
statistics, health care provider inputs, Specific Information from Medical https://www.regulations.gov. Follow the
incidence of alarms, and/or records of Devices with Patients Upon Request’’ instructions for submitting comments.
device malfunctions or failures. may send an email request to CDRH- Comments submitted electronically,
FDA developed this guidance to Guidance@fda.hhs.gov to receive an including attachments, to https://
convey FDA’s position regarding electronic copy of the document. Please www.regulations.gov will be posted to
manufacturers appropriately and use the document number 1500067 to the docket unchanged. Because your
responsibly sharing patient-specific identify the guidance you are comment will be made public, you are
information with that patient at that requesting. solely responsible for ensuring that your
patient’s request. In general, comment does not include any
Dated: October 24, 2017.
manufacturers may do so without confidential information that you or a
undergoing additional premarket review Lauren Silvis, third party may not wish to be posted,
in advance. FDA generally would not Chief of Staff. such as medical information, your or
consider patient-specific information to [FR Doc. 2017–23517 Filed 10–27–17; 8:45 am] anyone else’s Social Security number, or
be ‘‘labeling,’’ as defined in section BILLING CODE 4164–01–P confidential business information, such
201(m) of the Federal Food, Drug, and as a manufacturing process. Please note
Cosmetic Act (the FD&C Act) (21 U.S.C. that if you include your name, contact
321(m)). FDA is aware that when DEPARTMENT OF HEALTH AND information, or other information that
manufacturers share patient-specific HUMAN SERVICES identifies you in the body of your
information with patients, comments, that information will be
manufacturers also may provide them Food and Drug Administration posted on https://www.regulations.gov.
with supplemental information or other [Docket No. FDA–2017–D–6069] • If you want to submit a comment
materials (e.g., descriptions of intended with confidential information that you
use, benefit and risk information, Acceptance Review for De Novo do not wish to be made available to the
instructions for use) that may be Classification Requests; Draft public, submit the comment as a
considered labeling. Any labeling is Guidance for Industry and Food and written/paper submission and in the
subject to applicable requirements in Drug Administration Staff; Availability manner detailed (see ‘‘Written/Paper
the FD&C Act and FDA regulations. Submissions’’ and ‘‘Instructions’’).
AGENCY: Food and Drug Administration,
In the Federal Register of June 10,
HHS. Written/Paper Submissions
2016 (81 FR 37603), FDA announced the
availability of the draft guidance ACTION: Notice of availability. Submit written/paper submissions as
formerly entitled ‘‘Dissemination of follows:
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
Patient-Specific Information from Administration (FDA or Agency) is
Devices by Device Manufacturers’’ and written/paper submissions): Dockets
announcing the availability of the draft Management Staff (HFA–305), Food and
interested parties were invited to guidance entitled ‘‘Acceptance Review
comment by August 9, 2016. FDA has Drug Administration, 5630 Fishers
for De Novo Classification Requests.’’ Lane, Rm. 1061, Rockville, MD 20852.
considered all of the public comments The purpose of this draft guidance is to
received prior to finalizing this • For written/paper comments
explain the procedures and criteria FDA submitted to the Dockets Management
guidance. intends to use in assessing whether a Staff, FDA will post your comment, as
II. Significance of Guidance request for an evaluation of automatic well as any attachments, except for
This guidance is being issued class III designation (De Novo information submitted, marked and
consistent with FDA’s good guidance classification request or De Novo identified, as confidential, if submitted
practices regulation (21 CFR 10.115). request) meets a minimum threshold of as detailed in ‘‘Instructions.’’
The guidance represents the current acceptability and should be accepted for Instructions: All submissions received
thinking of FDA on ‘‘Manufacturers substantive review. This draft guidance must include the Docket No. FDA–
Sharing Patient-Specific Information discusses De Novo acceptance review 2017–D–6069 for ‘‘Acceptance Review
from Medical Devices with Patients policies and procedures, ‘‘Refuse to for De Novo Classification Requests;
Upon Request.’’ It does not establish any Accept’’ principles, and the elements of Draft Guidance for Industry and Food
rights for any person and is not binding the De Novo Acceptance Checklist and and Drug Administration Staff;
on FDA or the public. You can use an the Recommended Content Checklist Availability.’’ Received comments will
alternative approach if it satisfies the and is being issued to be responsive to be placed in the docket and, except for
requirements of the applicable statutes an explicit deliverable identified in the those submitted as ‘‘Confidential
and regulations. This guidance is not Medical Device User Fee Amendments Submissions,’’ publicly viewable at
subject to Executive Order 12866. of 2017 (MDUFA IV). This draft https://www.regulations.gov or at the
guidance is not final nor is it in effect
sradovich on DSK3GMQ082PROD with NOTICES
Dockets Management Staff between 9
III. Electronic Access at this time. a.m. and 4 p.m., Monday through
Persons interested in obtaining a copy DATES: Submit either electronic or Friday.
of the guidance may do so by written comments on the draft guidance • Confidential Submissions—To
downloading an electronic copy from by December 29, 2017 to ensure that the submit a comment with confidential
the internet. A search capability for all Agency considers your comment on this information that you do not wish to be
Center for Devices and Radiological draft guidance before it begins work on made publicly available, submit your
Health guidance documents is available the final version of the guidance. comments only as a written/paper
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Document Created: 2017-10-28 00:28:56
Document Modified: 2017-10-28 00:28:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on October 30, 2017. | |
| 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. | |
| FR Citation | 82 FR 50134 |
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