Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability, 60291-60292 [2013-23795]

Download as PDF Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices Dated: September 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–23794 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0787] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.’’ Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data, often before the device design is finalized. This guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical study protocol during the early feasibility study. 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: Submit written requests for single copies of the guidance document entitled ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002 or Office of Communication, emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the 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: Dorothy Abel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1204, Silver Spring, MD 20993–0002, 301–796–6366; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background This guidance is intended to provide assistance to FDA staff, clinicians, medical device innovators, and industry on the development and review of IDE applications (21 CFR 812.20) for early feasibility studies of significant risk devices. Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data in a limited number of subjects. During these studies, iterative device modifications are likely to be made based on clinical experience. Early feasibility studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. As with all clinical studies, initiation of an early feasibility study must be justified by an appropriate benefit/risk analysis and adequate human subject protection measures. This guidance discusses the key principles unique to the justification for, and design of, early feasibility studies, and outlines the general principles for preparing and reviewing early feasibility study IDE applications. This guidance is not intended to address all required elements of an IDE application or to provide a comprehensive tutorial on PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 60291 best clinical practices for investigational medical device studies. Concurrent with the publication of this guidance in draft, November 10, 2011 (76 FR 70150), FDA initiated a pilot program for early feasibility study IDE applications (November 10, 2011, 76 FR 70152) to solicit nominations from sponsors of innovative device technologies. In addition to making clarifications within the final guidance in response to comments from the public on the draft guidance, FDA has incorporated changes based on information learned and experiences gained from the pilot program. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the Agency’s current thinking on IDEs for Early Feasibility Medical Device Clinical Studies. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1782 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 812 have been approved under OMB control number 0910–0078; E:\FR\FM\01OCN1.SGM 01OCN1 60292 Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices and the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910–0130. 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: September 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–23795 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. 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. FOR FURTHER INFORMATION CONTACT: Johnny Young, Center for Drug Evaluation and Research (HFD–613), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240– 276–8677. SUPPLEMENTARY INFORMATION: I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1120] Draft Guidance for Industry on Abbreviated New Drug Application Submissions—Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Refuse-to-Receive Standards.’’ This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission. 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 on 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 October 31, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 FDA is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Refuse-toReceive Standards.’’ This guidance is intended to assist applicants preparing to submit to FDA ANDAs and PASs to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance contains details on what should be included in an ANDA and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA. A refuse-toreceive decision indicates that FDA has determined that an ANDA is incomplete on its face, usually because of omissions. With the enactment of the Generic Drug User Fee Act on July 9, 2012 (Pub. L. 112–144, Title III), FDA’s Office of Generic Drugs (OGD) was tasked with a number of activities, including developing enhanced refusal to receive standards for ANDAs and related submissions. Recent data underscore the need for improvement in the quality of original ANDA submissions. Between 2009 and 2012, OGD refused to receive 497 ANDAs, primarily because the submissions contained serious deficiencies. FDA evaluates each incoming ANDA individually to determine whether its format and content meet threshold criteria to permit a substantive review and can thus be received by FDA. The Agency cannot receive an ANDA unless it contains the information required under section 505(j) of the Federal Food, Drug, and Cosmetic Act and related regulations (e.g., 21 CFR 314.101(b)(1)). This guidance explains in some detail the PO 00000 Frm 00050 Fmt 4703 Sfmt 9990 kind of omissions that can lead to a refuse-to-receive determination. The guidance is intended to assist applicants preparing ANDAs and related submissions to help improve the quality of those submissions and ensure that their format and content meet the threshold criteria for FDA receipt and review. 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 Agency’s current thinking on refusing to receive ANDAs and related submissions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 collection of information in 21 CFR part 314 for ANDA and related submissions has been approved under OMB control number 0910–0001. III. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http://www. regulations.gov. Dated: September 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–23793 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60291-60292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0787]


Investigational Device Exemptions for Early Feasibility Medical 
Device Clinical Studies, Including Certain First in Human Studies; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Investigational Device 
Exemptions (IDEs) for Early Feasibility Medical Device Clinical 
Studies, Including Certain First in Human (FIH) Studies.'' Through the 
approaches announced in this guidance, FDA intends to facilitate early 
feasibility studies of medical devices, using appropriate risk 
mitigation strategies, under the IDE regulations. Early feasibility 
studies allow for limited early clinical evaluations of devices to 
provide proof of principle and initial clinical safety data, often 
before the device design is finalized. This guidance addresses the 
information that should be provided to FDA in support of an early 
feasibility study IDE application and explains the requirements 
applicable to modifications to the device design or clinical study 
protocol during the early feasibility study.

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: Submit written requests for single copies of the guidance 
document entitled ``Investigational Device Exemptions (IDEs) for Early 
Feasibility Medical Device Clinical Studies, Including Certain First in 
Human (FIH) Studies'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002 or 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the 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: Dorothy Abel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1204, Silver Spring, MD 20993-0002, 301-796-6366; 
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is intended to provide assistance to FDA staff, 
clinicians, medical device innovators, and industry on the development 
and review of IDE applications (21 CFR 812.20) for early feasibility 
studies of significant risk devices. Early feasibility studies allow 
for early clinical evaluation of devices to provide proof of principle 
and initial clinical safety data in a limited number of subjects. 
During these studies, iterative device modifications are likely to be 
made based on clinical experience. Early feasibility studies may be 
appropriate early in device development when clinical experience is 
necessary because nonclinical testing methods are not available or 
adequate to provide the information needed to advance the developmental 
process. As with all clinical studies, initiation of an early 
feasibility study must be justified by an appropriate benefit/risk 
analysis and adequate human subject protection measures.
    This guidance discusses the key principles unique to the 
justification for, and design of, early feasibility studies, and 
outlines the general principles for preparing and reviewing early 
feasibility study IDE applications. This guidance is not intended to 
address all required elements of an IDE application or to provide a 
comprehensive tutorial on best clinical practices for investigational 
medical device studies.
    Concurrent with the publication of this guidance in draft, November 
10, 2011 (76 FR 70150), FDA initiated a pilot program for early 
feasibility study IDE applications (November 10, 2011, 76 FR 70152) to 
solicit nominations from sponsors of innovative device technologies. In 
addition to making clarifications within the final guidance in response 
to comments from the public on the draft guidance, FDA has incorporated 
changes based on information learned and experiences gained from the 
pilot program.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
Agency's current thinking on IDEs for Early Feasibility Medical Device 
Clinical Studies. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Investigational Device Exemptions (IDEs) for Early Feasibility 
Medical Device Clinical Studies, Including Certain First in Human (FIH) 
Studies,'' you may either send an email request to dsmica@fda.hhs.gov 
to receive an electronic copy of the document or send a fax request to 
301-847-8149 to receive a hard copy. Please use the document number 
1782 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 812 have been approved under 
OMB control number 0910-0078;

[[Page 60292]]

and the collections of information in 21 CFR 56.115 have been approved 
under OMB control number 0910-0130.

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: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23795 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P