81 FR 4303 - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 16 (January 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 16 (January 26, 2016)
| Page Range | 4303-4305 | |
| FR Document | 2016-01471 |
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)] [Notices] [Pages 4303-4305] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01471] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4852] Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices''. FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 28, 2016.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 4304]] Instructions: All submissions received must include the Docket No. FDA-2015-D-4852 for ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices''. 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 ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices'' 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; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Heather Agler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-6340; and Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background The need and desire to connect medical devices to other products, technologies, and systems is growing in the health care community. As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices, as well as other technology, offers the potential to increase efficiency in patient care. FDA intends to promote the development and availability of safe and effective interoperable medical devices. FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. 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 ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices''. 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500015 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. 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 part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; the collections of information in 21 CFR [[Page 4305]] part 601 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485. Dated: January 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01471 Filed 1-25-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4303
for selection of potential nominees to DEPARTMENT OF HEALTH AND exchanged information. This document
replace members whose terms will end HUMAN SERVICES highlights considerations that should be
on June 30, 2017. Selection of members included in the development and design
is based on candidates’ qualifications to Centers for Disease Control and of interoperable medical devices and
contribute to the accomplishment of Prevention provides recommendations for the
ACIP objectives (http://www.cdc.gov/ content of premarket submissions and
Board of Scientific Counselors, labeling for such devices. This draft
vaccines/acip/index.html). The U.S.
National Center for Health Statistics guidance is not final nor is it in effect
Department of Health and Human (BSC, NCHS)
Services policy stipulates that at this time.
committee membership be balanced in Notice of Cancellation: This notice DATES: Although you can comment on
terms of professional training and was published in the Federal Register any guidance at any time (see 21 CFR
background, points of view represented, on December 23, 2015, Volume 80, 10.115(g)(5)), to ensure that the Agency
Number 246, pages 79899–79900. The considers your comment of this draft
and the committee’s function.
meeting previously scheduled to guidance before it begins work on the
Consideration is given to a broad
convene on January 21–22, 2016, has final version of the guidance, submit
representation of geographic areas either electronic or written comments
within the U.S., with equitable been cancelled.
Contact Person for More Information: on the draft guidance by March 28,
representation of the sexes, ethnic and 2016.
racial minorities, and persons with Virginia S. Cain, Ph.D., Director of
Extramural Research, NCHS/CDC, 3311 ADDRESSES: You may submit comments
disabilities. Nominees must be U.S.
Toledo Road, Room 7208, Hyattsville, as follows:
citizens, and cannot be full-time
Maryland 20782, Telephone (301) 458–
employees of the U.S. Government. Electronic Submissions
4395, Fax (301) 458–4020, Email:
Candidates should submit the following vcain@cdc.gov. Submit electronic comments in the
items: The Director, Management Analysis following way:
D Current curriculum vitae, including and Services Office, has been delegated • Federal eRulemaking Portal: http://
complete contact information the authority to sign Federal Register www.regulations.gov. Follow the
(telephone numbers, mailing address, notices pertaining to announcements of instructions for submitting comments.
email address) meetings and other committee Comments submitted electronically,
management activities for both the including attachments, to http://
D At least one letter of www.regulations.gov will be posted to
Centers for Disease Control and
recommendation from person(s) not the docket unchanged. Because your
Prevention and the Agency for Toxic
employed by HHS * comment will be made public, you are
Substances and Disease Registry.
The deadline for receipt of all solely responsible for ensuring that your
application materials (for consideration Elaine L. Baker, comment does not include any
for term beginning July 1, 2017) is Director, Management Analysis and Services confidential information that you or a
Office, Centers for Disease Control and third party may not wish to be posted,
November 4, 2016. All files must be
Prevention. such as medical information, your or
submitted electronically as email
attachments to: Ms. Stephanie Thomas,
[FR Doc. 2016–01442 Filed 1–25–16; 8:45 am] anyone else’s Social Security number, or
BILLING CODE 4163–18–P confidential business information, such
ACIP Secretariat, Email: SThomas5@
as a manufacturing process. Please note
cdc.gov.
that if you include your name, contact
Nominations may be submitted by the DEPARTMENT OF HEALTH AND information, or other information that
candidate him- or herself, or by the HUMAN SERVICES identifies you in the body of your
person/organization recommending the comments, that information will be
candidate. Food and Drug Administration posted on http://www.regulations.gov.
* Candidates may submit letter(s) from [Docket No. FDA–2015–D–4852] • If you want to submit a comment
current HHS employees if they wish, but at
with confidential information that you
least one letter must be submitted by a Design Considerations and Premarket do not wish to be made available to the
person not employed by HHS (e.g., CDC, Submission Recommendations for public, submit the comment as a
NIH, FDA, etc.). Interoperable Medical Devices; Draft written/paper submission and in the
Guidance for Industry and Food and manner detailed (see ‘‘Written/Paper
The Director, Management Analysis Drug Administration Staff; Availability Submissions’’ and ‘‘Instructions’’).
and Services Office, has been delegated Written/Paper Submissions
AGENCY: Food and Drug Administration,
the authority to sign Federal Register HHS. Submit written/paper submissions as
notices pertaining to announcements of
ACTION: Notice of availability. follows:
meetings and other committee • Mail/Hand delivery/Courier (for
management activities for both the SUMMARY: The Food and Drug written/paper submissions): Division of
Centers for Disease Control and Administration (FDA or Agency) is Dockets Management (HFA–305), Food
Prevention and the Agency for Toxic announcing the availability of the draft and Drug Administration, 5630 Fishers
Substances and Disease Registry. guidance entitled ‘‘Design Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
mstockstill on DSK4VPTVN1PROD with NOTICES
Considerations and Pre-market
Elaine L. Baker,
Submission Recommendations for submitted to the Division of Dockets
Director, Management Analysis and Services Interoperable Medical Devices’’. FDA is Management, FDA will post your
Office, Centers for Disease Control and issuing this draft guidance to assist comment, as well as any attachments,
Prevention.
industry and FDA staff in identifying except for information submitted,
[FR Doc. 2016–01443 Filed 1–25–16; 8:45 am]
specific considerations related to the marked and identified, as confidential,
BILLING CODE 4163–18–P ability of electronic medical devices to if submitted as detailed in
safely and effectively exchange and use ‘‘Instructions’’.
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![Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4305
part 601 have been approved under Electronic Submissions • Confidential Submissions—To
OMB control number 0910–0338; and Submit electronic comments in the submit a comment with confidential
the collections of information in 21 CFR following way: information that you do not wish to be
parts 801 and 809 have been approved • Federal eRulemaking Portal: http:// made publicly available, submit your
under OMB control number 0910–0485. www.regulations.gov. Follow the comments only as a written/paper
Dated: January 21, 2016. instructions for submitting comments. submission. You should submit two
Leslie Kux, Comments submitted electronically, copies total. One copy will include the
including attachments, to http:// information you claim to be confidential
Associate Commissioner for Policy.
www.regulations.gov will be posted to with a heading or cover note that states
[FR Doc. 2016–01471 Filed 1–25–16; 8:45 am]
the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4164–01–P
comment will be made public, you are CONFIDENTIAL INFORMATION.’’ The
solely responsible for ensuring that your Agency will review this copy, including
comment does not include any the claimed confidential information, in
DEPARTMENT OF HEALTH AND
confidential information that you or a its consideration of comments. The
HUMAN SERVICES
third party may not wish to be posted, second copy, which will have the
Food and Drug Administration such as medical information, your or claimed confidential information
anyone else’s Social Security number, or redacted/blacked out, will be available
[Docket No. FDA–2016–N–0117] confidential business information, such for public viewing and posted on http://
as a manufacturing process. Please note www.regulations.gov. Submit both
International Drug Scheduling;
that if you include your name, contact copies to the Division of Dockets
Convention on Psychotropic
information, or other information that Management. If you do not wish your
Substances; Single Convention on
identifies you in the body of your name and contact information to be
Narcotic Drugs; World Health
comments, that information will be made publicly available, you can
Organization; Scheduling
posted on http://www.regulations.gov. provide this information on the cover
Recommendations; Acetylfentanyl;
• If you want to submit a comment sheet and not in the body of your
MT–45; para-
with confidential information that you comments and you must identify this
Methoxymethylamphetamine (PMMA);
do not wish to be made available to the information as ‘‘confidential.’’ Any
α-Pyrrolidinovalerophenone (α-PVP); public, submit the comment as a information marked as ‘‘confidential’’
para-Methyl-4-methylaminorex (4,4′- written/paper submission and in the will not be disclosed except in
DMAR); Methoxetamine (MXE); manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
Phenazepam; Request for Comments Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
AGENCY: Food and Drug Administration, Written/Paper Submissions information about FDA’s posting of
HHS. comments to public dockets, see 80 FR
ACTION: Notice. Submit written/paper submissions as 56469, September 18, 2015, or access
follows: the information at: http://www.fda.gov/
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for regulatoryinformation/dockets/
Administration (FDA) is providing written/paper submissions): Division of default.htm.
interested persons with the opportunity Dockets Management (HFA–305), Food Docket: For access to the docket to
to submit written comments, and to and Drug Administration, 5630 Fishers read background documents or the
request an informal public meeting Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
concerning recommendations by the • For written/paper comments
received, go to http://
World Health Organization (WHO) to submitted to the Division of Dockets
www.regulations.gov and insert the
impose international manufacturing and Management, FDA will post your
docket number, found in brackets in the
distributing restrictions, under comment, as well as any attachments,
heading of this document, into the
international treaties, on certain drug except for information submitted,
‘‘Search’’ box and follow the prompts
substances. The comments received in marked and identified, as confidential,
and/or go to the Division of Dockets
response to this notice and/or public if submitted as detailed in
‘‘Instructions.’’ Management, 5630 Fishers Lane, Rm.
meeting will be considered in preparing 1061, Rockville, MD 20852.
the United States’ position on these Instructions: All submissions received
must include the Docket No. FDA– FOR FURTHER INFORMATION CONTACT:
proposals for a meeting of the United James R. Hunter, Center for Drug
Nations Commission on Narcotic Drugs 2015–N–0117 for ‘‘International Drug
Scheduling; Convention on Evaluation and Research, Controlled
(CND) in Vienna, Austria, in March Substance Staff, Food and Drug
Psychotropic Substances; Single
2016. This notice is issued under the Administration, 10903 New Hampshire
Convention on Narcotic Drugs; World
Controlled Substances Act (the CSA). Ave., Bldg. 51, Rm. 5150, Silver Spring,
Health Organization; Scheduling
DATES: Submit either electronic or MD 20993–0002, 301–796–3156,
Recommendations; Acetylfentanyl; MT–
written comments by February 25, 2016. 45; para-Methoxymethylamphetamine james.hunter@fda.hhs.gov.
Submit requests for a public meeting on (PMMA); a-Pyrrolidinovalerophenone SUPPLEMENTARY INFORMATION:
or before February 5, 2016. The short (a-PVP); para-Methyl-4-methylaminorex
time period for the submission of (4,4′-DMAR); Methoxetamine (MXE); I. Background
comments and requests for a public Phenazepam; Request for Comments.’’ The United States is a party to the
meeting is needed to ensure that HHS
mstockstill on DSK4VPTVN1PROD with NOTICES
Received comments will be placed in 1971 Convention on Psychotropic
may, in a timely fashion, carry out the the docket and, except for those Substances (Psychotropic Convention).
required action and be responsive to the submitted as ‘‘Confidential Section 201(d)(2)(B) of the CSA (21
United Nations. For additional Submissions,’’ publicly viewable at U.S.C. 811(d)(2)(B)) provides that when
information, see section IV of this http://www.regulations.gov or at the the United States is notified under
document. Division of Dockets Management Article 2 of the Psychotropic
ADDRESSES: You may submit comments between 9 a.m. and 4 p.m., Monday Convention that the CND proposes to
as follows: through Friday. decide whether to add a drug or other
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Document Created: 2018-02-02 12:38:02
Document Modified: 2018-02-02 12:38:02
| 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 | 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 March 28, 2016. | |
| Contact | Heather Agler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-6340; and Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 4303 |
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