81 FR 11807 - Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 44 (March 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11807-11808 | |
| FR Document | 2016-04947 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Pages 11807-11808] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04947] [[Page 11807]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0539] Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this draft guidance to assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 6, 2016.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.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-0539 for ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' 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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes'' 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: Carlos Pe[ntilde]a, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301- 796-6610. SUPPLEMENTARY INFORMATION: I. Background FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful may represent a revolutionary option for patients. FDA developed this draft guidance to assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. The draft guidance is intended to aid industry and FDA staff in considering the benefits and risks of medical devices that target either the cause or progression of the neurological disorder or condition such as Alzheimer's disease, Parkinson's [[Page 11808]] Disease, or Primary Dystonia, rather than their symptoms. This draft guidance is intended to apply to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes. This draft guidance provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments. 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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' 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.regulations.gov. Persons unable to download an electronic copy of ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500021 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 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910- 0485; the collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0755; and the collections of information in the guidance document entitled ``Request for Feedback on Medical Device Submissions: The Pre-submission Program and Meetings With Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: March 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04947 Filed 3-4-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11807
DEPARTMENT OF HEALTH AND comments, that information will be will not be disclosed except in
HUMAN SERVICES posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
Food and Drug Administration with confidential information that you information about FDA’s posting of
[Docket No. FDA–2016–D–0539]
do not wish to be made available to the comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
Clinical Considerations for written/paper submission and in the the information at: http://www.fda.gov/
Investigational Device Exemptions for manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Neurological Devices Targeting Submissions’’ and ‘‘Instructions’’). default.htm.
Disease Progression and Clinical Written/Paper Submissions Docket: For access to the docket to
Outcomes; Draft Guidance for Industry read background documents or the
and Food and Drug Administration Submit written/paper submissions as electronic and written/paper comments
Staff; Availability follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
AGENCY: Food and Drug Administration, written/paper submissions): Division of docket number, found in brackets in the
HHS. Dockets Management (HFA–305), Food heading of this document, into the
ACTION: Notice of availability. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments
Administration (FDA or Agency) is Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets
announcing the availability of the draft Management, FDA will post your 1061, Rockville, MD 20852.
guidance entitled ‘‘Clinical An electronic copy of the guidance
comment, as well as any attachments,
Considerations for Investigational except for information submitted, document is available for download
Device Exemptions (IDEs) for marked and identified, as confidential, from the Internet. See the
Neurological Devices Targeting Disease SUPPLEMENTARY INFORMATION section for
if submitted as detailed in
Progression and Clinical Outcomes.’’ ‘‘Instructions.’’ information on electronic access to the
The Center for Devices and Radiological Instructions: All submissions received guidance. Submit written requests for a
Health (CDRH) developed this draft must include the Docket No. FDA– single hard copy of the draft guidance
guidance to assist sponsors who intend 2016–D–0539 for ‘‘Clinical document entitled ‘‘Clinical
to submit an IDE to the FDA to conduct Considerations for Investigational Considerations for Investigational
clinical trials on medical devices Device Exemptions (IDEs) for Device Exemptions (IDEs) for
targeting neurological disease Neurological Devices Targeting Disease Neurological Devices Targeting Disease
progression and clinically meaningful Progression and Clinical Outcomes.’’ Progression and Clinical Outcomes’’ to
patient centered outcomes. This draft Received comments will be placed in the Office of the Center Director,
guidance is not final nor is it in effect the docket and, except for those Guidance and Policy Development,
at this time. submitted as ‘‘Confidential Center for Devices and Radiological
DATES: Although you can comment on Submissions,’’ publicly viewable at Health, Food and Drug Administration,
any guidance at any time (see 21 CFR http://www.regulations.gov or at the 10903 New Hampshire Ave., Bldg. 66,
10.115(g)(5)), to ensure that the Agency Division of Dockets Management Rm. 5431, Silver Spring, MD 20993–
considers your comment of this draft between 9 a.m. and 4 p.m., Monday 0002. Send one self-addressed adhesive
guidance before it begins work on the through Friday. label to assist that office in processing
final version of the guidance, submit • Confidential Submissions—To your request.
either electronic or written comments submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
on the draft guidance by June 6, 2016. information that you do not wish to be Carlos Peña, Center for Devices and
ADDRESSES: You may submit comments made publicly available, submit your Radiological Health, Food and Drug
as follows: comments only as a written/paper Administration, 10903 New Hampshire
submission. You should submit two Ave., Bldg. 66, Rm. 2680, Silver Spring,
Electronic Submissions copies total. One copy will include the MD 20993–0002, 301–796–6610.
Submit electronic comments in the information you claim to be confidential SUPPLEMENTARY INFORMATION:
following way: with a heading or cover note that states
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS I. Background
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The FDA believes that neurological
instructions for submitting comments. Agency will review this copy, including devices intended to slow disease
Comments submitted electronically, the claimed confidential information, in progression and improve clinical
including attachments, to http:// its consideration of comments. The outcomes that are meaningful may
www.regulations.gov will be posted to second copy, which will have the represent a revolutionary option for
the docket unchanged. Because your claimed confidential information patients. FDA developed this draft
comment will be made public, you are redacted/blacked out, will be available guidance to assist sponsors who intend
solely responsible for ensuring that your for public viewing and posted on http:// to submit an IDE to the FDA to conduct
comment does not include any www.regulations.gov. Submit both clinical trials on medical devices
confidential information that you or a copies to the Division of Dockets targeting neurological disease
asabaliauskas on DSK3SPTVN1PROD with NOTICES
third party may not wish to be posted, Management. If you do not wish your progression and clinically meaningful
such as medical information, your or name and contact information to be patient centered outcomes. The draft
anyone else’s Social Security number, or made publicly available, you can guidance is intended to aid industry and
confidential business information, such provide this information on the cover FDA staff in considering the benefits
as a manufacturing process. Please note sheet and not in the body of your and risks of medical devices that target
that if you include your name, contact comments and you must identify this either the cause or progression of the
information, or other information that information as ‘‘confidential.’’ Any neurological disorder or condition such
identifies you in the body of your information marked as ‘‘confidential’’ as Alzheimer’s disease, Parkinson’s
VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\07MRN1.SGM 07MRN1](https://thefederalregister.org/doc/81_FR_11851/page/1.svg)
![11808 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
Disease, or Primary Dystonia, rather collections of information in 21 CFR ADDRESSES: You may submit comments
than their symptoms. This draft part 50 have been approved under OMB as follows:
guidance is intended to apply to control number 0910–0755; and the
Electronic Submissions
neurological medical devices that are collections of information in the
designed to slow, stop, or reverse the guidance document entitled ‘‘Request Submit electronic comments in the
progression of disease and result in for Feedback on Medical Device following way:
clinically meaningful patient outcomes. Submissions: The Pre-submission • Federal eRulemaking Portal: http://
This draft guidance provides general Program and Meetings With Food and www.regulations.gov. Follow the
study design considerations for clinical Drug Administration Staff’’ have been instructions for submitting comments.
trials that investigate neurological approved under OMB control number Comments submitted electronically,
devices using biological markers and 0910–0756. including attachments, to http://
clinical outcome assessments. www.regulations.gov will be posted to
Dated: March 1, 2016.
the docket unchanged. Because your
II. Significance of Guidance Leslie Kux, comment will be made public, you are
This draft guidance is being issued Associate Commissioner for Policy. solely responsible for ensuring that your
consistent with FDA’s good guidance [FR Doc. 2016–04947 Filed 3–4–16; 8:45 am] comment does not include any
practices regulation (21 CFR 10.115). BILLING CODE 4164–01–P confidential information that you or a
The draft guidance, when finalized, will third party may not wish to be posted,
represent the current thinking of FDA such as medical information, your or
on ‘‘Clinical Considerations for DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Investigational Device Exemptions HUMAN SERVICES confidential business information, such
(IDEs) for Neurological Devices as a manufacturing process. Please note
Targeting Disease Progression and Food and Drug Administration that if you include your name, contact
Clinical Outcomes.’’ It does not [Docket No. FDA–2016–D–0768] information, or other information that
establish any rights for any person and identifies you in the body of your
is not binding on FDA or the public. Donor Screening Recommendations comments, that information will be
You can use an alternative approach if To Reduce the Risk of Transmission of posted on http://www.regulations.gov.
it satisfies the requirements of the Zika Virus by Human Cells, Tissues, • If you want to submit a comment
applicable statutes and regulations. and Cellular and Tissue-Based with confidential information that you
Products; Guidance for Industry; do not wish to be made available to the
III. Electronic Access
Availability public, submit the comment as a
Persons interested in obtaining a copy written/paper submission and in the
of the draft guidance may do so by AGENCY: Food and Drug Administration,
manner detailed (see ‘‘Written/Paper
downloading an electronic copy from HHS.
Submissions’’ and ‘‘Instructions’’).
the Internet. A search capability for all ACTION: Notice of availability.
Center for Devices and Radiological Written/Paper Submissions
Health guidance documents is available SUMMARY: The Food and Drug
Submit written/paper submissions as
at http://www.fda.gov/ MedicalDevices/ Administration (FDA or Agency) is
follows:
DeviceRegulationandGuidance/ announcing the availability of a • Mail/Hand delivery/Courier (for
GuidanceDocuments/default.htm. document entitled ‘‘Donor Screening written/paper submissions): Division of
Guidance documents are also available Recommendations to Reduce the Risk of Dockets Management (HFA–305), Food
at http://www.regulations.gov. Persons Transmission of Zika Virus by Human and Drug Administration, 5630 Fishers
unable to download an electronic copy Cells, Tissues, and Cellular and Tissue- Lane, Rm. 1061, Rockville, MD 20852.
of ‘‘Clinical Considerations for Based Products; Guidance for Industry.’’ • For written/paper comments
Investigational Device Exemptions The guidance document provides submitted to the Division of Dockets
(IDEs) for Neurological Devices establishments that make donor Management, FDA will post your
Targeting Disease Progression and eligibility (DE) determinations for comment, as well as any attachments,
Clinical Outcomes’’ may send an email donors of human cells, tissues, and except for information submitted,
request to CDRH-Guidance@fda.hhs.gov cellular and tissue-based products marked and identified, as confidential,
to receive an electronic copy of the (HCT/Ps) with recommendations for if submitted as detailed in
document. Please use the document screening donors for evidence of, and ‘‘Instructions.’’
number 1500021 to identify the risk factors for, infection with Zika virus Instructions: All submissions received
guidance you are requesting. (ZIKV). The guidance identifies ZIKV as must include the Docket No. FDA–
a relevant communicable disease agent 2016–D–0545 for ‘‘Donor Screening
IV. Paperwork Reduction Act of 1995 or disease (RCDAD) and adds to Recommendations to Reduce the Risk of
This draft guidance refers to recommendations contained in the Transmission of Zika Virus by Human
previously approved collections of guidance entitled ‘‘Eligibility Cells, Tissues, and Cellular and Tissue-
information found in FDA regulations. Determination for Donors of Human Based Products; Guidance for Industry.’’
These collections of information are Cells, Tissues, and Cellular and Tissue- Received comments will be placed in
subject to review by the Office of Based Products (HCT/Ps)’’ dated August the docket and, except for those
Management and Budget (OMB) under 2007. submitted as ‘‘Confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the Paperwork Reduction Act of 1995 DATES: The Agency is soliciting public Submissions,’’ publicly viewable at
(44 U.S.C. 3501–3520). The collections comment, but is implementing this http://www.regulations.gov or at the
of information in 21 CFR part 812 have guidance immediately because the Division of Dockets Management
been approved under OMB control Agency has determined that prior public between 9 a.m. and 4 p.m., Monday
number 0910–0078; the collections of participation is not feasible or through Friday.
information in 21 CFR parts 801 and appropriate. Submit either electronic or • Confidential Submissions—To
809 have been approved under OMB written comments on Agency guidances submit a comment with confidential
control number 0910–0485; the at any time. information that you do not wish to be
VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\07MRN1.SGM 07MRN1](https://thefederalregister.org/doc/81_FR_11851/page/2.svg)
Document Created: 2018-02-02 15:07:48
Document Modified: 2018-02-02 15:07:48
| 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 June 6, 2016. | |
| Contact | Carlos Pe[ntilde]a, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301- 796-6610. | |
| FR Citation | 81 FR 11807 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR