80_FR_28371 80 FR 28276 - Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

80 FR 28276 - Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 95 (May 18, 2015)

Page Range28276-28277
FR Document2015-11820

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.'' 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. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 80 Issue 95 (Monday, May 18, 2015) 
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28276-28277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1439]


Adaptive Designs for Medical Device Clinical Studies; Draft 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Adaptive Designs for 
Medical Device Clinical Studies; Draft Guidance for Industry and Food 
and Drug Administration Staff.'' 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. 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 August 17, 2015.

ADDRESSES: 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 
``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance 
for Industry and Food and Drug Administration Staff'' 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Greg Campbell, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2110, Silver Spring, MD 20993-0002, 301-796-5750.

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, premarket notification (510(k)) submissions, de novo 
submissions (evaluation of automatic class III designation), 
humanitarian device exemption applications, and investigational device 
exemption 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.

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 the adaptive 
design of clinical

[[Page 28277]]

studies for medical devices. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statute 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 ``Adaptive Designs for Medical 
Device Clinical Studies; Draft Guidance for Industry and Food and Drug 
Administration Staff'' 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 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 807, subpart E, which have 
been approved under 0910-0120; 21 CFR part 812, which have been 
approved under 0910-0078; 21 CFR part 814, subparts A, B, and C, which 
have been approved under OMB control number 0910-0231; and 21 CFR part 
814, subpart H, which have been approved under OMB control number 0910-
0332.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11820 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P

28276 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices written comments to the Division of will be posted to the docket at http:// SUPPLEMENTARY INFORMATION section for Dockets Management (HFA–305), Food www.regulations.gov. information on electronic access to the and Drug Administration, 5630 Fishers guidance. Submit written requests for a III. Electronic Access Lane, Rm. 1061, Rockville, MD 20852. single hard copy of the draft guidance See the SUPPLEMENTARY INFORMATION Persons with access to the Internet document entitled ‘‘Adaptive Designs section for electronic access to the draft may obtain the proposed for Medical Device Clinical Studies; recommendations for preparing the recommendations at either http:// Draft Guidance for Industry and Food Standardization Plan. www.fda.gov/forindustry/ and Drug Administration Staff’’ to the datastandards/studydatastandards/ Office of the Center Director, Guidance FOR FURTHER INFORMATION CONTACT: Ron default.htm or http:// and Policy Development, Center for Fitzmartin, Center for Drug Evaluation www.regulations.gov. Devices and Radiological Health, Food and Research, Food and Drug Administration, 10903 New Hampshire Dated: May 11, 2015. and Drug Administration, 10903 New Ave., Bldg. 51, Rm. 1192, Silver Spring, Leslie Kux, Hampshire Ave., Bldg. 66, Rm. 5431, MD 20993–002, 301–796–5333, email: Associate Commissioner for Policy. Silver Spring, MD 20993–0002. Send ronald.fitzmartin@fda.hhs.gov. [FR Doc. 2015–11846 Filed 5–15–15; 8:45 am] one self-addressed adhesive label to assist that office in processing your BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: request. I. Background Submit electronic comments on the DEPARTMENT OF HEALTH AND draft guidance to http:// FDA is announcing the availability of HUMAN SERVICES www.regulations.gov. Submit written draft recommendations for preparing the comments to the Division of Dockets Standardization Plan. The Food and Drug Administration Management (HFA–305), Food and Drug Standardization Plan is referenced in Administration, 5630 Fishers Lane, Rm. the Guide. The Guide supplements the [Docket No. FDA–2015–D–1439] 1061, Rockville, MD 20852. Identify guidance for industry ‘‘Providing Adaptive Designs for Medical Device comments with the docket number Regulatory Submissions in Electronic Clinical Studies; Draft Guidance for found in brackets in the heading of this Format—Standardized Study Data’’ and Industry and Food and Drug document. provides specifications, Administration Staff; Availability FOR FURTHER INFORMATION CONTACT: Greg recommendations, and general Campbell, Center for Devices and considerations on submitting AGENCY: Food and Drug Administration, Radiological Health, Food and Drug standardized study data using FDA- HHS. Administration, 10903 New Hampshire supported data standards; it is posted on ACTION: Notice. Ave., Bldg. 66, Rm. 2110, Silver Spring, FDA’s Study Data Standards Resources MD 20993–0002, 301–796–5750. Web page at http://www.fda.gov/ SUMMARY: The Food and Drug Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: forindustry/datastandards/ studydatastandards/default.htm. availability of the draft guidance I. Background The Guide recommends that, for entitled ‘‘Adaptive Designs for Medical Device Clinical Studies; Draft Guidance This guidance provides sponsors and clinical and nonclinical studies, FDA staff with guidance on how to plan sponsors include a plan that describes for Industry and Food and Drug Administration Staff.’’ This guidance and implement adaptive designs for the submission of standardized study clinical studies when used in medical data to FDA. The Standardization Plan provides sponsors and FDA staff with guidance on how to plan and implement device development programs. This will assist FDA in identifying potential document addresses adaptive designs data standardization issues early in the adaptive designs for clinical studies when used in medical device for medical device clinical trials and is development program (e.g., pre- applicable to premarket medical device investigational new drug application development programs. An adaptive design for a medical device clinical submissions including premarket stage). The draft recommendations approval applications, premarket describe the information that should be study is defined as a clinical trial design that allows for prospectively planned notification (510(k)) submissions, de included in the Standardization Plan. novo submissions (evaluation of The recommendations include, but are modifications based on accumulating study data without undermining the automatic class III designation), not limited to, the following: (1) General humanitarian device exemption sponsor information, (2) product trial’s integrity and validity. Adaptive designs, when properly implemented, applications, and investigational device information, (3) list of completed exemption submissions. This guidance studies and standards, and (4) list of can reduce resource requirements and/ or increase the chance of study success. can be applied throughout the clinical planned studies and standards. development program of a medical This draft guidance is not final nor is it II. Comments in effect at this time. device, from feasibility studies to pivotal clinical trials. This guidance Interested persons may submit either DATES: Although you can comment on does not apply to clinical studies of electronic comments regarding this any guidance at any time (see 21 CFR combination products or codevelopment document to http://www.regulations.gov 10.115(g)(5)), to ensure that the Agency of a pharmaceutical product with an or written comments to the Division of considers your comment of this draft asabaliauskas on DSK5VPTVN1PROD with NOTICES unapproved diagnostic test. Dockets Management (see ADDRESSES). It guidance before it begins work on the is only necessary to send one set of final version of the guidance, submit II. Significance of Guidance comments. Identify comments with the either electronic or written comments This draft guidance is being issued docket number found in brackets in the on the draft guidance by August 17, consistent with FDA’s good guidance heading of this document. Received 2015. practices regulation (21 CFR 10.115). comments may be seen in the Division ADDRESSES: An electronic copy of the The draft guidance, when finalized, will of Dockets Management between 9 a.m. guidance document is available for represent the current thinking of FDA and 4 p.m., Monday through Friday, and download from the Internet. See the on the adaptive design of clinical VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1

Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 28277 studies for medical devices. It does not Dated: May 12, 2015. Labeling’’ to the Office of the Center establish any rights for any person and Leslie Kux, Director, Guidance and Policy is not binding on FDA or the public. Associate Commissioner for Policy. Development, Center for Devices and You can use an alternative approach if [FR Doc. 2015–11820 Filed 5–15–15; 8:45 am] Radiological Health, Food and Drug it satisfies the requirements of the BILLING CODE 4164–01–P Administration, 10903 New Hampshire applicable statute and regulations. Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or the Office of III. Electronic Access DEPARTMENT OF HEALTH AND Communication, Outreach, and HUMAN SERVICES Development, Center for Biologics Persons interested in obtaining a copy Evaluation and Research, Food and of the draft guidance may do so by Food and Drug Administration Drug Administration, 10903 New downloading an electronic copy from [Docket No. FDA–2015–D–1580] Hampshire Ave., Bldg. 71, Rm. 3128, the Internet. A search capability for all Silver Spring, MD 20993–0002. Send Center for Devices and Radiological one self-addressed adhesive label to Health guidance documents is available Patient Preference Information— Submission, Review in Premarket assist that office in processing your at http://www.fda.gov/MedicalDevices/ request. Approval Applications, Humanitarian DeviceRegulationandGuidance/ Submit electronic comments on the Device Exemption Applications, and GuidanceDocuments/default.htm. draft guidance to http:// De Novo Requests, and Inclusion in Guidance documents are also available www.regulations.gov. Submit written Device Labeling; Draft Guidance for at http://www.regulations.gov. Persons Industry, Food and Drug comments to the Division of Dockets unable to download an electronic copy Administration Staff, and Other Management (HFA–305), Food and Drug of ‘‘Adaptive Designs for Medical Stakeholders; Availability Administration, 5630 Fishers Lane, Rm. Device Clinical Studies; Draft Guidance 1061, Rockville, MD 20852. Identify for Industry and Food and Drug AGENCY: Food and Drug Administration, comments with the docket number Administration Staff’’ may send an HHS. found in brackets in the heading of this email request to CDRH-Guidance@ ACTION: Notice. document. fda.hhs.gov to receive an electronic FOR FURTHER INFORMATION CONTACT: copy of the document. Please use the SUMMARY: The Food and Drug Anindita Saha, Center for Devices and document number GUD1500005 to Administration (FDA or Agency) is Radiological Health, Food and Drug identify the guidance you are announcing the availability of a draft Administration, 10903 New Hampshire requesting. guidance for industry entitled ‘‘Patient Ave., Bldg. 66, Rm. 5414, Silver Spring, Preference Information—Submission, IV. Paperwork Reduction Act of 1995 MD 20993–0002, 301–796–2537, Review in PMAs, HDE Applications, Anindita.Saha@fda.hhs.gov; or Stephen and De Novo Requests, and Inclusion in This draft guidance refers to Ripley, Center for Biologics Evaluation Device Labeling.’’ This document previously approved collections of and Research, Food and Drug provides guidance on collecting and information found in FDA regulations. Administration, 10903 New Hampshire submitting patient preference These collections of information are Ave., Bldg. 71, Rm. 7301, Silver Spring, information that may be used by FDA subject to review by the Office of MD 20993, 240–402–7911. staff in decisionmaking relating to Management and Budget (OMB) under premarket approval applications SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 (PMAs), Humanitarian Device I. Background (44 U.S.C. 3501–3520). The collections Exemption (HDE) applications, and de of information in 21 CFR part 807, novo requests. This draft guidance also FDA is announcing the availability of subpart E, which have been approved outlines considerations for including a draft guidance for industry entitled under 0910–0120; 21 CFR part 812, patient preference information in ‘‘Patient Preference Information— which have been approved under 0910– labeling for patients and health care Submission, Review in PMAs, HDE 0078; 21 CFR part 814, subparts A, B, professionals. This draft guidance is not Applications, and De Novo Requests, and C, which have been approved under final nor is it in effect at this time. and Inclusion in Device Labeling.’’ FDA OMB control number 0910–0231; and believes that patients can and should DATES: Although you can comment on 21 CFR part 814, subpart H, which have bring their own experiences to bear in any guidance at any time (see 21 CFR helping the Agency to evaluate the risk- been approved under OMB control 10.115(g)(5)), to ensure that the Agency number 0910–0332. benefit profile of certain devices. This considers your comment on this draft document provides guidance on V. Comments guidance before it begins work on the collecting and submitting patient final version of the guidance, submit preference information that may be used Interested persons may submit either either electronic or written comments by FDA staff in decision-making relating electronic comments regarding this on the draft guidance by August 17, to PMAs, HDE applications, and de document to http://www.regulations.gov 2015. novo requests. The objectives of this or written comments to the Division of ADDRESSES: An electronic copy of the draft guidance are: (1) To encourage Dockets Management (see ADDRESSES). It guidance document is available for voluntary submission of patient is only necessary to send one set of download from the Internet. See the preference information by sponsors or asabaliauskas on DSK5VPTVN1PROD with NOTICES comments. Identify comments with the SUPPLEMENTARY INFORMATION section for other stakeholders in certain docket number found in brackets in the information on electronic access to the circumstances; (2) to outline heading of this document. Received guidance. Submit written requests for a recommended qualities of patient comments may be seen in the Division single hard copy of the draft guidance preference studies, which may result in of Dockets Management between 9 a.m. document entitled ‘‘Patient Preference valid scientific evidence; (3) to provide and 4 p.m., Monday through Friday, and Information—Submission, Review in recommendations for collecting and will be posted to the docket at http:// PMAs, HDE Applications, and De Novo submitting patient preference www.regulations.gov. Requests, and Inclusion in Device information to FDA; and (4) to outline VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1


Document Created: 2015-12-16 07:38:38
Document Modified: 2015-12-16 07:38:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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 August 17, 2015.
ContactGreg Campbell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2110, Silver Spring, MD 20993-0002, 301-796-5750.
FR Citation80 FR 28276 
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