80 FR 48869 - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 157 (August 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 157 (August 14, 2015)
| Page Range | 48869-48870 | |
| FR Document | 2015-19990 |
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)] [Notices] [Pages 48869-48870] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19990] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2711] Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ``Neurodiagnostics and Non- Invasive Brain Stimulation Medical Devices Workshop''. The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval of future submissions. Dates and Times: The public workshop will be held on November 19 and 20, 2015, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. [[Page 48870]] Contact Persons: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, [email protected]; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, [email protected], 301-796-2795. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 6, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, [email protected] or 301-796-5661 no later than November 5, 2015. To register for the public workshop, please visit FDA's Medical Devices Workshops and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this meeting/public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact for special accommodations). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., November 6, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 10, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 5, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when providing comments to the topics as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: I. Background Cognitive assessment medical devices are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. Non-invasive brain stimulation medical devices are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., has no cognitive impairment) by means of non-invasive electrical or electromagnetic stimulation to the head. These medical devices both present important safety and effectiveness questions as well as study design and data analysis challenges. II. Topics for Discussion at the Public Workshop The workshop seeks to involve industry and academia in addressing scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. By bringing together relevant stakeholders, which include scientists, patient advocates, clinicians, researchers, industry representatives, and regulators, to this workshop, we hope to facilitate the improvement of this rapidly evolving product area. This workshop is aimed to address scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function; including, but not limited to, the following topic areas:Considerations for clinical study trial designs, patient populations, and patient selection methods; considerations for clinical study endpoints, e.g., clinically relevant outcome measures and related statistical analyses; identification of risks and risk mitigation strategies; and evaluation of prior studies, current clinical research, and available scientific and clinical evidence. Dated: August 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19990 Filed 8-13-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48869
and product code HLJ, electronic copy of the document. Please DEPARTMENT OF HEALTH AND
Ophthalmoscope, Battery-powered (see use the document number 1300046 to HUMAN SERVICES
21 CFR 886.1570—Ophthalmoscope). identify the guidance you are
FDA has determined it is appropriate to requesting. Food and Drug Administration
add these product codes to the guidance
because FDA has tentatively concluded IV. Paperwork Reduction Act of 1995 [Docket No. FDA–2015–N–2711]
they are sufficiently well understood
This guidance refers to previously Neurodiagnostics and Non-Invasive
and do not require premarket
approved collections of information Brain Stimulation Medical Devices;
notification (510(k)) to assure their
safety and effectiveness. found in FDA regulations. These Public Workshop; Request for
Seven comments also requested the collections of information are subject to Comments
removal or clarification of specific review by the Office of Management and
Budget (OMB) under the Paperwork AGENCY: Food and Drug Administration,
product codes in the draft guidance. The
Reduction Act of 1995 (44 U.S.C. 3501– HHS.
issues raised in these comments were
addressed by the removal of certain 3520). The collections of information in ACTION: Notice of public workshop;
product codes from the draft guidance, 21 CFR part 807, subpart E, have been request for comments.
and the clarification of two product approved under OMB control number SUMMARY: The Food and Drug
codes: Product code MRQ, Analyzer, 0910–0120. Administration (FDA) is announcing the
Nitrogen Dioxide; and product code following two-day public workshop
KKX, Drape, Surgical. Moreover, in V. Comments
entitled, ‘‘Neurodiagnostics and Non-
response to the issues raised, FDA is Interested persons may submit either Invasive Brain Stimulation Medical
clarifying that it is not the Agency’s electronic comments regarding this Devices Workshop’’. The focus of the
intent to exempt combination products
document to http://www.regulations.gov first day of the workshop will be
or single entity products containing
or written comments to the Division of cognitive assessment medical devices,
antimicrobial agents. For the remaining
Dockets Management (see ADDRESSES). It which are intended to provide
product codes identified in those
is only necessary to send one set of healthcare professionals with an
comments, FDA believes that the
comments. Identify comments with the evaluation of cognitive function through
product codes are sufficiently well
docket number found in brackets in the non-invasive measurements. The focus
understood and do not require
premarket notification (510(k)) to assure heading of this document. Received of the second day of the workshop will
their safety and effectiveness. Thus, comments may be seen in the Division be non-invasive brain stimulation
FDA has not removed these products of Dockets Management between 9 a.m. medical devices, which are medical
codes from the guidance. and 4 p.m., Monday through Friday, and devices that are intended to improve,
will be posted to the docket at http:// affect, or otherwise modify the cognitive
II. Significance of Guidance function of a normal individual (i.e.,
www.regulations.gov.
This guidance is being issued without a treatment objective) by means
consistent with FDA’s good guidance VI. References of non-invasive electrical or
practices regulation (21 CFR 10.115). electromagnetic stimulation to the head.
The following references have been The purpose of this workshop is to
The guidance represents the current
thinking of FDA on the intent to exempt placed on display in the Division of obtain public input and feedback on
certain unclassified, class II, and class I Dockets Management (see ADDRESSES) scientific, clinical, and regulatory
reserved medical devices from and may be seen by interested persons considerations associated with medical
premarket notification requirements. It between 9 a.m. and 4 p.m., Monday devices for assessing and influencing
does not establish any rights for any through Friday. (FDA has verified the cognitive function. Ideas generated
person and is not binding on FDA or the Web site addresses in this reference during this workshop may facilitate
public. You can use an alternative section, but we are not responsible for further development of guidance
approach if it satisfies the requirements any subsequent changes to the Web sites regarding the content of premarket
of the applicable statutes and after this document publishes in the submissions for neurodiagnostics and
regulations. Federal Register.) non-invasive brain stimulation medical
devices and help to speed development
III. Electronic Access 1. FDA announced that it would
and approval of future submissions.
exercise enforcement discretion for
Persons interested in obtaining a copy Dates and Times: The public
premarket notification for the following
of the guidance may do so by workshop will be held on November 19
downloading an electronic copy from product codes, among others, if the and 20, 2015, from 8:30 a.m. to 5 p.m.
the Internet. A search capability for all devices meet the criteria set forth in Location: The public workshop will
Center for Devices and Radiological guidance: OFX, OKF, OKG, OKH, OKI, be held at FDA’s White Oak Campus,
Health guidance documents is available LRO, and OJW. See Convenience Kits 10903 New Hampshire Ave., Bldg. 31
at http://www.fda.gov/MedicalDevices/ Interim Regulatory Guidance (May Conference Center, the Great Room (rm.
DeviceRegulationandGuidance/ 1997), available at http://www.fda.gov/ 1503), Silver Spring, MD 20993–0002.
GuidanceDocuments/default.htm. downloads/MedicalDevices/ Entrance for the public meeting
Guidance documents are also available DeviceRegulationandGuidance/ participants (non-FDA employees) is
asabaliauskas on DSK5VPTVN1PROD with NOTICES
at http://www.regulations.gov. Persons GuidanceDocuments/ucm080217.pdf. through Building 1 where routine
unable to download an electronic copy Dated: August 10, 2015. security check procedures will be
of ‘‘Intent to Exempt Certain performed. For parking and security
Leslie Kux,
Unclassified, Class II, and Class I information, please refer to: http://
Reserved Medical Devices from Associate Commissioner for Policy. www.fda.gov/AboutFDA/
Premarket Notification Requirements’’ [FR Doc. 2015–20005 Filed 8–13–15; 8:45 am] WorkingatFDA/BuildingsandFacilities/
may send an email request to CDRH- BILLING CODE 4164–01–P WhiteOakCampusInformation/
Guidance@fda.hhs.gov to receive an ucm241740.htm.
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![48870 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
Contact Persons: Hilda Scharen, verified the Web site addresses in this devices both present important safety
Center for Devices and Radiological document, but FDA is not responsible and effectiveness questions as well as
Health, Food and Drug Administration, for any subsequent changes to the Web study design and data analysis
10903 New Hampshire Ave., Bldg. 66, sites after this document publishes in challenges.
Rm 3625, Silver Spring, MD 20993, the Federal Register.)
Comments: In order to permit the II. Topics for Discussion at the Public
301–796–6815, Hilda.Scharen@
fda.hhs.gov; or Jay Gupta, Center for widest possible opportunity to obtain Workshop
Devices and Radiological Health, Food public comment, FDA is soliciting The workshop seeks to involve
and Drug Administration, 10903 New either electronic or written comments industry and academia in addressing
Hampshire Ave., Silver Spring, MD on all aspects of the public workshop scientific, clinical, and regulatory
20993, Jay.Gupta@fda.hhs.gov, 301– topics. The deadline for submitting considerations associated with medical
796–2795. comments related to this public devices for assessing and influencing
Registration: Registration is free and workshop is December 5, 2015. cognitive function. By bringing together
available on a first-come, first-served Regardless of attendance at the public relevant stakeholders, which include
basis. Persons interested in attending workshop, interested persons may scientists, patient advocates, clinicians,
this public workshop must register submit either electronic comments researchers, industry representatives,
online by November 6, 2015, at 4 p.m. regarding this document to http:// and regulators, to this workshop, we
Early registration is recommended www.regulations.gov or written hope to facilitate the improvement of
because facilities are limited and, comments to the Division of Dockets this rapidly evolving product area.
therefore, FDA may limit the number of Management (HFA–305), Food and Drug This workshop is aimed to address
participants from each organization. If Administration, 5630 Fishers Lane, rm. scientific, clinical, and regulatory
time and space permits, onsite 1061, Rockville, MD 20852. It is only considerations associated with medical
registration on the day of the public necessary to send one set of comments. devices for assessing and influencing
workshop will be provided beginning at Identify comments with the docket cognitive function; including, but not
7:30 a.m. number found in brackets in the limited to, the following topic areas:
If you need special accommodations heading of this document. In addition, • Considerations for clinical study
due to a disability, please contact Susan when providing comments to the topics trial designs, patient populations, and
Monahan, susan.monahan@fda.hhs.gov as outlined in section II of this patient selection methods;
or 301–796–5661 no later than document, please identify the question • considerations for clinical study
November 5, 2015. you are addressing. Received comments endpoints, e.g., clinically relevant
To register for the public workshop, may be seen in the Division of Dockets outcome measures and related statistical
please visit FDA’s Medical Devices Management between 9 a.m. and 4 p.m., analyses;
Workshops and Conferences calendar at Monday through Friday, and will be • identification of risks and risk
http://www.fda.gov/MedicalDevices/ posted to the docket at http:// mitigation strategies; and
NewsEvents/WorkshopsConferences/ www.regulations.gov. • evaluation of prior studies, current
default.htm. Select this meeting/public Transcripts: Please be advised that as
clinical research, and available
workshop from the posted events list. soon as a transcript is available, it will
scientific and clinical evidence.
Please provide complete contact be accessible at http://
information for each attendee, including www.regulations.gov. It may be viewed Dated: August 10, 2015.
name, title, affiliation, email, and at the Division of Dockets Management Leslie Kux,
telephone number. Those without (see Comments). A transcript will also Associate Commissioner for Policy.
Internet access should contact Susan be available in either hardcopy or on [FR Doc. 2015–19990 Filed 8–13–15; 8:45 am]
Monahan to register (see Contact for CD–ROM, after submission of a BILLING CODE 4164–01–P
special accommodations). Registrants Freedom of Information request. The
will receive confirmation after they have address of the Division of Freedom of
been accepted. You will be notified if Information is available on the Agency’s DEPARTMENT OF HEALTH AND
you are on a waiting list. Web site at http://www.fda.gov. A link HUMAN SERVICES
Streaming Webcast of the Public to the transcripts will also be available
Workshop: This public workshop will approximately 45 days after the public Food and Drug Administration
also be available via Webcast. Persons workshop on the Internet at http://
interested in viewing the Webcast must [Docket No. FDA–2015–N–0001]
www.fda.gov/MedicalDevices/
register online by 4 p.m., November 6, NewsEvents/WorkshopsConferences/ Science Advisory Board to the
2015. Early registration is recommended default.htm. (Select this public National Center for Toxicological
because Webcast connections are workshop from the posted events list). Research Advisory Committee; Notice
limited. Organizations are requested to SUPPLEMENTARY INFORMATION: of Meeting
register all participants, but to view
using one connection per location. I. Background AGENCY: Food and Drug Administration,
Webcast participants will be sent Cognitive assessment medical devices HHS.
technical system requirements after are intended to provide healthcare ACTION: Notice.
registration and will be sent connection professionals with an evaluation of
access information after November 10, cognitive function through non-invasive This notice announces a forthcoming
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2015. If you have never attended a measurements. Non-invasive brain meeting of a public advisory committee
Connect Pro event before, test your stimulation medical devices are of the Food and Drug Administration
connection at https:// intended to improve, affect, or (FDA). At least one portion of the
collaboration.fda.gov/common/help/en/ otherwise modify the cognitive function meeting will be closed to the public.
support/meeting_test.htm. To get a of a normal individual (i.e., has no Name of Committee: Science
quick overview of the Connect Pro cognitive impairment) by means of non- Advisory Board (SAB) to the National
program, visit http://www.adobe.com/ invasive electrical or electromagnetic Center for Toxicological Research
go/connectpro_overview. (FDA has stimulation to the head. These medical (NCTR).
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Document Created: 2018-02-23 10:58:55
Document Modified: 2018-02-23 10:58:55
| 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 public workshop; request for comments. | |
| FR Citation | 80 FR 48869 |
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