50134 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

Desk Officer for the Administration for 

Children and Families. 

Bob Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–23467 Filed 10–27–17; 8:45 am] 

BILLING CODE 4184–01–P 

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 ‘‘patientspecific 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 selfaddressed 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 ‘‘patientspecific 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 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 PatientSpecific Information from Medical 

Devices with Patients Upon Request’’ 

may send an email request to CDRHGuidance@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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6069] 

Acceptance Review for De Novo 

Classification Requests; Draft 

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 draft 

guidance entitled ‘‘Acceptance Review 

for De Novo Classification Requests.’’ 

The purpose of this draft guidance is to 

explain the procedures and criteria FDA 

intends to use in assessing whether a 

request for an evaluation of automatic 

class III designation (De Novo 

classification request or De Novo 

request) meets a minimum threshold of 

acceptability and should be accepted for 

substantive review. This draft guidance 

discusses De Novo acceptance review 

policies and procedures, ‘‘Refuse to 

Accept’’ principles, and the elements of 

the De Novo Acceptance Checklist and 

the Recommended Content Checklist 

and is being issued to be responsive to 

an explicit deliverable identified in the 

Medical Device User Fee Amendments 

of 2017 (MDUFA IV). This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 29, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2017–D–6069 for ‘‘Acceptance Review 

for De Novo Classification Requests; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES