81 FR 49230 - Adaptive Designs for Medical Device Clinical Studies; 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 144 (July 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 144 (July 27, 2016)
| Page Range | 49230-49231 | |
| FR Document | 2016-17651 |
[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)] [Notices] [Pages 49230-49231] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17651] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1439] Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Adaptive Designs for Medical Device Clinical Studies.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. 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-2015-D-1439 for ``Adaptive Designs for Medical Device Clinical Studies.'' 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 [[Page 49231]] 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 guidance document entitled ``Adaptive Designs for Medical Device Clinical Studies'' 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: Gerry Gray, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2112, Silver Spring, MD 20993-0002, 301-796-6012; or the Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5750; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. This document addresses adaptive designs for medical device clinical trials and is applicable to premarket medical device submissions including premarket approval applications (PMA), premarket notification (510(k)) submissions, de novo submissions (evaluation of automatic class III designation), humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility studies to pivotal clinical trials. This guidance does not apply to clinical studies of combination products or codevelopment of a pharmaceutical product with an unapproved diagnostic test. The draft guidance was available from May 18, 2015, to August 17, 2015. FDA received 151 comments from seven entities and has incorporated most of them in this final guidance. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Adaptive Designs for Medical Device Clinical Studies.'' 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 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 ``Adaptive Designs for Medical Device Clinical Studies'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number GUD1500005 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 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; 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 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; and the collections of information in the guidance document ``Requests 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: July 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17651 Filed 7-26-16; 8:45 am] BILLING CODE 4164-01-P
![49230 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
II. Significance of Guidance for informed consent) have been ADDRESSES: You may submit comments
This draft guidance is being issued approved under OMB control number as follows:
consistent with FDA’s good guidance 0910–0586; the collections of
Electronic Submissions
practices regulation (21 CFR 10.115). information in 21 CFR part 54 (financial
disclosure by clinical investigators) Submit electronic comments in the
The draft guidance, when finalized, will following way:
represent the current thinking of FDA have been approved under OMB control
number 0910–0396; the collections of • Federal eRulemaking Portal: http://
on ‘‘Use of Real-World Evidence to www.regulations.gov. Follow the
Support Regulatory Decisionmaking for information in 21 CFR part 56.115 (IRB
records) have been approved under instructions for submitting comments.
Medical Devices.’’ It does not establish Comments submitted electronically,
any rights for any person and is not OMB control number 0910–0130; and
the collections of information in 21 CFR including attachments, to http://
binding on FDA or the public. You can www.regulations.gov will be posted to
use an alternative approach if it satisfies parts 50 (informed consent) and 56
(IRBs) have been approved under OMB the docket unchanged. Because your
the requirements of the applicable comment will be made public, you are
statutes and regulations. control number 0910–0755. The
collections of information in the solely responsible for ensuring that your
III. Electronic Access guidance ‘‘Requests for Feedback on comment does not include any
Medical Device Submissions: The Pre- confidential information that you or a
Persons interested in obtaining a copy third party may not wish to be posted,
of the draft guidance may do so by Submission Program and Meetings with
Food and Drug Administration Staff’’ such as medical information, your or
downloading an electronic copy from anyone else’s Social Security number, or
the Internet. A search capability for all have been approved under OMB control
number 0910–0756. confidential business information, such
Center for Devices and Radiological as a manufacturing process. Please note
Health guidance documents is available Dated: July 22, 2016.
that if you include your name, contact
at http://www.fda.gov/MedicalDevices/ Leslie Kux, information, or other information that
DeviceRegulationandGuidance/ Associate Commissioner for Policy. identifies you in the body of your
GuidanceDocuments/default.htm. [FR Doc. 2016–17750 Filed 7–26–16; 8:45 am] comments, that information will be
Guidance documents are also available BILLING CODE 4164–01–P posted on http://www.regulations.gov.
at http://www.regulations.gov. Persons • If you want to submit a comment
unable to download an electronic copy with confidential information that you
of ‘‘Use of Real-World Evidence to DEPARTMENT OF HEALTH AND do not wish to be made available to the
Support Regulatory Decisionmaking for HUMAN SERVICES public, submit the comment as a
Medical Devices’’ may send an email written/paper submission and in the
request to CDRH-Guidance@fda.hhs.gov Food and Drug Administration manner detailed (see ‘‘Written/Paper
to receive an electronic copy of the Submissions’’ and ‘‘Instructions’’).
document. Please use the document [Docket No. FDA–2015–D–1439]
number 1500012 to identify the Written/Paper Submissions
guidance you are requesting. Adaptive Designs for Medical Device Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 Clinical Studies; Guidance for Industry follows:
and Food and Drug Administration • Mail/Hand delivery/Courier (for
This guidance refers to previously Staff; Availability written/paper submissions): Division of
approved collections of information Dockets Management (HFA–305), Food
found in FDA regulations and guidance. AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
These collections of information are HHS. Lane, Rm. 1061, Rockville, MD 20852.
subject to review by the Office of ACTION: Notice of availability. • For written/paper comments
Management and Budget (OMB) under submitted to the Division of Dockets
the Paperwork Reduction Act of 1995 SUMMARY: The Food and Drug Management, FDA will post your
(44 U.S.C. 3501–3520). The collections Administration (FDA or Agency) is comment, as well as any attachments,
of information in 21 CFR part 807, announcing the availability of the except for information submitted,
subpart E have been approved under guidance entitled ‘‘Adaptive Designs for marked, and identified, as confidential,
OMB control number 0910–0120; the Medical Device Clinical Studies.’’ This if submitted as detailed in
collections of information in 21 CFR guidance provides sponsors and FDA ‘‘Instructions.’’
part 814, subparts A through E staff with guidance on how to plan and Instructions: All submissions received
(premarket approval) have been implement adaptive designs for clinical must include the Docket No. FDA–
approved under OMB control number studies when used in medical device 2015–D–1439 for ‘‘Adaptive Designs for
0910–0231; the collections of development programs. An adaptive Medical Device Clinical Studies.’’
information in 21 CFR part 814, subpart design for a medical device clinical Received comments will be placed in
H (humanitarian device exemption) study is defined as a clinical trial design the docket and, except for those
have been approved under OMB control that allows for prospectively planned submitted as ‘‘Confidential
number 0910–0332; the collections of modifications based on accumulating Submissions,’’ publicly viewable at
information in 21 CFR part 812 study data without undermining the http://www.regulations.gov or at the
(investigational device exemption) have trial’s integrity and validity. Adaptive Division of Dockets Management
been approved under OMB control designs, when properly implemented,
sradovich on DSK3GMQ082PROD with NOTICES
between 9 a.m. and 4 p.m., Monday
number 0910–0078; the collections of can reduce resource requirements and/ through Friday.
information in 21 CFR part 822 or increase the chance of study success. • Confidential Submissions—To
(postmarket surveillance) have been DATES: Submit either electronic or submit a comment with confidential
approved under OMB control number written comments on this guidance at information that you do not wish to be
0910–0449; the collections of any time. General comments on Agency made publicly available, submit your
information in 21 CFR part 50.23 guidance documents are welcome at any comments only as a written/paper
(exception from general requirements time. submission. You should submit two
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![Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices 49231
copies total. One copy will include the Radiological Health, Food and Drug DeviceRegulationandGuidance/
information you claim to be confidential Administration, 10903 New Hampshire GuidanceDocuments/default.htm.
with a heading or cover note that states Ave., Bldg. 66, Rm. 2112, Silver Spring, Guidance documents are also available
‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–796–6012; or the at http://www.fda.gov/BiologicsBlood
CONFIDENTIAL INFORMATION.’’ The Division of Biostatistics, Center for Vaccines/GuidanceCompliance
Agency will review this copy, including Devices and Radiological Health, Food RegulatoryInformation/default.htm or
the claimed confidential information, in and Drug Administration, 10903 New http://www.regulations.gov. Persons
its consideration of comments. The Hampshire Ave., Bldg. 66, Silver Spring, unable to download an electronic copy
second copy, which will have the MD 20993–0002, 301–796–5750; or of ‘‘Adaptive Designs for Medical
claimed confidential information Stephen Ripley, Center for Biologics Device Clinical Studies’’ may send an
redacted/blacked out, will be available Evaluation and Research, Food and email request to CDRH-Guidance@
for public viewing and posted on http:// Drug Administration, 10903 New fda.hhs.gov to receive an electronic
www.regulations.gov. Submit both Hampshire Ave., Bldg. 71, Rm. 7301, copy of the document. Please use the
copies to the Division of Dockets Silver Spring MD 20993, 240–402–7911. document number GUD1500005 to
Management. If you do not wish your SUPPLEMENTARY INFORMATION: identify the guidance you are
name and contact information to be requesting.
I. Background
made publicly available, you can IV. Paperwork Reduction Act of 1995
provide this information on the cover This guidance provides sponsors and
sheet and not in the body of your FDA staff with guidance on how to plan This guidance refers to previously
comments and you must identify this and implement adaptive designs for approved collections of information
information as ‘‘confidential.’’ Any clinical studies when used in medical found in FDA regulations. These
information marked as ‘‘confidential’’ device development programs. This collections of information are subject to
will not be disclosed except in document addresses adaptive designs review by the Office of Management and
accordance with 21 CFR 10.20 and other for medical device clinical trials and is Budget (OMB) under the Paperwork
applicable disclosure law. For more applicable to premarket medical device Reduction Act of 1995 (44 U.S.C. 3501–
information about FDA’s posting of submissions including premarket 3520). The collections of information in
comments to public dockets, see 80 FR approval applications (PMA), premarket 21 CFR part 807, subpart E have been
56469, September 18, 2015, or access notification (510(k)) submissions, de approved under OMB control number
the information at: http://www.fda.gov/ novo submissions (evaluation of 0910–0120; the collections of
regulatoryinformation/dockets/ automatic class III designation), information in 21 CFR part 812, have
default.htm. humanitarian device exemption (HDE) been approved under OMB control
Docket: For access to the docket to applications, and investigational device number 0910–0078; the collections of
read background documents or the exemption (IDE) submissions. This information in 21 CFR part 814,
electronic and written/paper comments guidance can be applied throughout the subparts A through E, have been
received, go to http:// clinical development program of a approved under OMB control number
www.regulations.gov and insert the medical device, from feasibility studies 0910–0231; the collections of
docket number, found in brackets in the to pivotal clinical trials. This guidance information in 21 CFR part 814,subpart
heading of this document, into the does not apply to clinical studies of H, have been approved under OMB
‘‘Search’’ box and follow the prompts combination products or codevelopment control number 0910–0332; and the
and/or go to the Division of Dockets of a pharmaceutical product with an collections of information in the
Management, 5630 Fishers Lane, Rm. unapproved diagnostic test. The draft guidance document ‘‘Requests for
1061, Rockville, MD 20852. guidance was available from May 18, Feedback on Medical Device
An electronic copy of the guidance 2015, to August 17, 2015. FDA received Submissions: The Pre-Submission
document is available for download 151 comments from seven entities and Program and Meetings with Food and
from the Internet. See the has incorporated most of them in this Drug Administration Staff’’ have been
SUPPLEMENTARY INFORMATION section for final guidance. approved under OMB control number
information on electronic access to the II. Significance of Guidance 0910–0756.
guidance. Submit written requests for a Dated: July 21, 2016.
This guidance is being issued
single hard copy of the guidance Leslie Kux,
consistent with FDA’s good guidance
document entitled ‘‘Adaptive Designs Associate Commissioner for Policy.
practices regulation (21 CFR 10.115).
for Medical Device Clinical Studies’’ to [FR Doc. 2016–17651 Filed 7–26–16; 8:45 am]
The guidance represents the current
the Office of the Center Director,
thinking of FDA on ‘‘Adaptive Designs BILLING CODE 4164–01–P
Guidance and Policy Development,
for Medical Device Clinical Studies.’’ It
Center for Devices and Radiological
does not establish any rights for any
Health, Food and Drug Administration, DEPARTMENT OF HEALTH AND
person and is not binding on FDA or the
10903 New Hampshire Ave., Bldg. 66, HUMAN SERVICES
public. You can use an alternative
Rm. 5431, Silver Spring, MD 20993–
approach if it satisfies the requirements
0002; or the Office of Communication, Health Resources and Services
of the applicable statutes and
Outreach, and Development, Center for Administration
regulations.
Biologics Evaluation and Research,
Food and Drug Administration, 10903 III. Electronic Access Advisory Committee on Heritable
sradovich on DSK3GMQ082PROD with NOTICES
New Hampshire Ave., Bldg. 71, Rm. Disorders in Newborns and Children;
Persons interested in obtaining a copy
3128, Silver Spring, MD 20993–0002. Notice of Meeting
of the guidance may do so by
Send one self-addressed adhesive label downloading an electronic copy from In accordance with section 10(a)(2) of
to assist that office in processing your the Internet. A search capability for all the Federal Advisory Committee Act
request. Center for Devices and Radiological (Pub. L. 92–463, codified at 5 U.S.C.
FOR FURTHER INFORMATION CONTACT: Health guidance documents is available App.), notice is hereby given of the
Gerry Gray, Center for Devices and at http://www.fda.gov/MedicalDevices/ following meeting:
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Document Created: 2018-02-08 08:02:44
Document Modified: 2018-02-08 08:02:44
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Gerry Gray, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2112, Silver Spring, MD 20993-0002, 301-796-6012; or the Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5750; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring MD 20993, 240-402-7911. | |
| FR Citation | 81 FR 49230 |
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