Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability, 60022-60024 [2017-27155]

Download as PDF 60022 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices FOR FURTHER INFORMATION CONTACT: daltland on DSKBBV9HB2PROD with NOTICES Michael Pacanowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 301– 796–3919; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.’’ This guidance is intended to assist sponsors in designing drug development programs to generate the evidence needed to demonstrate efficacy of a targeted therapy across subsets of patients with different underlying molecular alterations within a disease, where some molecular alterations may occur at low frequencies. In recent years, advances in our understanding of the molecular pathology of many diseases have led to the development of targeted therapies. Although variability in drug response has long been recognized in drug development, targeted therapies present new challenges in addressing the heterogeneity in drug response because the pharmacological effect of a targeted therapy is often related to a particular molecular alteration (e.g., a mutation, gene fusion, epigenetic change, etc.). Many clinically defined diseases are caused by a range of different molecular alterations, some of which may occur at low frequencies, that impact a common protein or pathway involved in the disease pathogenesis. In a population of patients with the same clinical disease, the heterogeneity in the molecular etiology may result in different responses to a particular therapy. However, certain targeted therapies may be effective in multiple groups of patients that have different underlying molecular alterations. Therefore, FDA is providing guidance on the type and quantity of evidence that can demonstrate efficacy across molecular subsets within a disease. This guidance addresses the following important topics in evaluating the benefits and risks of targeted therapeutics within a disease where some molecular alterations may occur at low frequencies: • Identification of patients for inclusion in clinical trials • Interpretation of study results and generalizability of findings VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 • Benefit-risk determination and therapeutic product labeling • Refining the indicated population after the initial approval In addition to comments on the general content of the draft guidance, FDA requests input on whether the principles described for grouping molecular subsets for clinical trial enrollment should be limited to diseases with low-frequency molecular alterations or whether they could be broadly applicable to all targeted therapies. 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 ‘‘Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.’’ 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27156 Filed 12–15–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6356] Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Investigational IVDs Used in Clinical Investigations of SUMMARY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Therapeutic Products.’’ This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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.’’ E:\FR\FM\18DEN1.SGM 18DEN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices Instructions: All submissions received must include the Docket No. FDA– 2017–N–6356 for ‘‘Investigational IVDs Used in Clinical Investigations of Therapeutic Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 document entitled ‘‘Investigational IVDs Used in Clinical Investigations of Therapeutic Products’’ 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: David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993–0002, 301–796–6697 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 draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational IVDs and IRBs that review such investigations in complying with the IDE regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance describes when the IDE regulation may apply to certain clinical investigations of therapeutic products; certain regulatory requirements that sponsors should be aware of as they develop and conduct such investigations; recommendations for determining the risk of investigational IVD use in a therapeutic product investigation; recommendations for IRBs in reviewing such investigations; and recommendations for content to provide in an IDE application, when required. Additionally, FDA is seeking feedback on the policy in the draft guidance regarding the need for an IDE for a significant risk study of an investigational IVD device with a therapeutic product under an IND. Specifically, FDA requests stakeholder perspectives on whether it would be beneficial to allow submission of all IDE components to an IND rather than require both an IDE and an IND. If such an approach would be beneficial, please PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 60023 identify any specific circumstances, for example a companion diagnostic and the associated therapeutic product, where efficiency may be improved or burden may be decreased, or both, without compromising patient safety. 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 Agency’s current thinking on investigational IVDs used in clinical investigations of therapeutic products. 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. This guidance is not subject to Executive Order 12866. 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This draft guidance is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Investigational IVDs Used in Clinical Investigations of Therapeutic Products’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400025 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information. 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 809 have been approved under OMB control number 0910–0485; the collections of information in parts 50 and 56 have been approved under OMB control number 0910–0755; the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910–0130; the collections of information in 21 CFR 50.23 have been approved under OMB control number 0910–0586; 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 820 have E:\FR\FM\18DEN1.SGM 18DEN1 60024 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices been approved under OMB control number 0910–0073; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of information in the guidance document entitled ‘‘Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with Food and Drug Administration Staff’’ have been approved under OMB control number 0910–0756. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27155 Filed 12–15–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6765] Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.’’ FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer’s application of an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. When finalized, this document will supersede ‘‘Replacement Reagent and Instrument Family Policy,’’ issued on December 11, 2003. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidances at any time as follows: daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2017–D–6765 for ‘‘Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ‘‘Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices’’ 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. Avis Danishefsky, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5620, Silver Spring, MD 20993–0002, 301–796–6142. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60022-60024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27155]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6356]


Investigational In Vitro Diagnostics Used in Clinical 
Investigations of Therapeutic Products; Draft Guidance for Industry, 
Food and Drug Administration Staff, Sponsors, and Institutional Review 
Boards; 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 ``Investigational IVDs 
Used in Clinical Investigations of Therapeutic Products.'' This draft 
guidance is intended to assist sponsors of clinical investigations of 
therapeutic products that also include investigational in vitro 
diagnostics (IVDs) and institutional review boards (IRBs) that review 
such investigations in complying with the Investigational Device 
Exemption (IDE) regulation. This draft guidance is also intended to 
assist FDA staff participating in the review of these investigations. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 19, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.''

[[Page 60023]]

    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6356 for ``Investigational IVDs Used in Clinical 
Investigations of Therapeutic Products.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Investigational IVDs Used in Clinical Investigations of Therapeutic 
Products'' 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: David Litwack, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993-0002, 301-796-6697 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 draft guidance is intended to assist sponsors of clinical 
investigations of therapeutic products that also include 
investigational IVDs and IRBs that review such investigations in 
complying with the IDE regulation. This draft guidance is also intended 
to assist FDA staff participating in the review of these 
investigations.
    This draft guidance describes when the IDE regulation may apply to 
certain clinical investigations of therapeutic products; certain 
regulatory requirements that sponsors should be aware of as they 
develop and conduct such investigations; recommendations for 
determining the risk of investigational IVD use in a therapeutic 
product investigation; recommendations for IRBs in reviewing such 
investigations; and recommendations for content to provide in an IDE 
application, when required.
    Additionally, FDA is seeking feedback on the policy in the draft 
guidance regarding the need for an IDE for a significant risk study of 
an investigational IVD device with a therapeutic product under an IND. 
Specifically, FDA requests stakeholder perspectives on whether it would 
be beneficial to allow submission of all IDE components to an IND 
rather than require both an IDE and an IND. If such an approach would 
be beneficial, please identify any specific circumstances, for example 
a companion diagnostic and the associated therapeutic product, where 
efficiency may be improved or burden may be decreased, or both, without 
compromising patient safety.

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 Agency's current thinking on 
investigational IVDs used in clinical investigations of therapeutic 
products. 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. 
This guidance is not subject to Executive Order 12866.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft 
guidance is also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Investigational IVDs Used in 
Clinical Investigations of Therapeutic Products'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1400025 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of 
information. 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 809 have been approved under OMB control number 0910-0485; the 
collections of information in parts 50 and 56 have been approved under 
OMB control number 0910-0755; the collections of information in 21 CFR 
56.115 have been approved under OMB control number 0910-0130; the 
collections of information in 21 CFR 50.23 have been approved under OMB 
control number 0910-0586; 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 820 have

[[Page 60024]]

been approved under OMB control number 0910-0073; the collections of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; and the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001. The collections 
of information in the guidance document entitled ``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: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27155 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P