Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments, 48869-48870 [2015-19990]

Download as PDF Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices and product code HLJ, Ophthalmoscope, Battery-powered (see 21 CFR 886.1570—Ophthalmoscope). FDA has determined it is appropriate to add these product codes to the guidance because FDA has tentatively concluded they are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Seven comments also requested the removal or clarification of specific product codes in the draft guidance. The issues raised in these comments were addressed by the removal of certain product codes from the draft guidance, and the clarification of two product codes: Product code MRQ, Analyzer, Nitrogen Dioxide; and product code KKX, Drape, Surgical. Moreover, in response to the issues raised, FDA is clarifying that it is not the Agency’s intent to exempt combination products or single entity products containing antimicrobial agents. For the remaining product codes identified in those comments, FDA believes that the product codes are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Thus, FDA has not removed these products codes from the guidance. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 the intent to exempt certain unclassified, class II, and class I reserved medical devices from premarket notification requirements. 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 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 ‘‘Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an VerDate Sep<11>2014 18:50 Aug 13, 2015 Jkt 235001 48869 electronic copy of the document. Please use the document number 1300046 to identify the guidance you are requesting. DEPARTMENT OF HEALTH AND HUMAN SERVICES IV. Paperwork Reduction Act of 1995 [Docket No. FDA–2015–N–2711] This 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 807, subpart E, have been approved under OMB control number 0910–0120. Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. 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 https:// www.regulations.gov. VI. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. FDA announced that it would exercise enforcement discretion for premarket notification for the following product codes, among others, if the devices meet the criteria set forth in guidance: OFX, OKF, OKG, OKH, OKI, LRO, and OJW. See Convenience Kits Interim Regulatory Guidance (May 1997), available at https://www.fda.gov/ downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm080217.pdf. Dated: August 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–20005 Filed 8–13–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Food and Drug Administration AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ‘‘Neurodiagnostics and NonInvasive 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: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. SUMMARY: E:\FR\FM\14AUN1.SGM 14AUN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 48870 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 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, Hilda.Scharen@ fda.hhs.gov; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 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, susan.monahan@fda.hhs.gov 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 https://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 https://www.adobe.com/ go/connectpro_overview. (FDA has VerDate Sep<11>2014 18:50 Aug 13, 2015 Jkt 235001 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 https:// 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 https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// 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 https://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https:// 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 noninvasive electrical or electromagnetic stimulation to the head. These medical PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48869-48870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19990]


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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: https://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, 
Hilda.Scharen@fda.hhs.gov; or Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 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, susan.monahan@fda.hhs.gov 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 https://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 https://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 https://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 https://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://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 https://www.fda.gov. A link to the transcripts will also be 
available approximately 45 days after the public workshop on the 
Internet at https://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
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