Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability, 67175-67176 [2014-26694]

Download as PDF Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0258] Combined Functionality for Molecular Diagnostic Instruments; 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 ‘‘Molecular Diagnostic Instruments with Combined Functions.’’ This guidance document provides industry and Agency staff with FDA’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/ cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. 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: 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 ‘‘Molecular Diagnostic Instruments With Combined Functions’’ 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 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. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:55 Nov 10, 2014 Jkt 235001 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: Andrew Grove, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993–0002, 301–796–6198; 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 This guidance document provides industry and Agency staff with FDA’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/ clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. Molecular diagnostic instruments, for example, real-time thermocyclers, are critical components of certain in vitro diagnostic devices. They are often used to perform multiple unrelated assays, such as those that detect methicillin resistant Staphylococcus aureus, hepatitis C virus, and genetic markers of cystic fibrosis. These types of instruments cannot generally be approved/cleared alone, i.e., without an accompanying assay, because their safety and effectiveness cannot be evaluated without reference to the assays that they run and their defined performance parameters. However, the same instruments may also be used for additional purposes that do not require FDA approval or clearance, such as for basic scientific research. In the past, FDA has provided informal advice in response to individual inquiries regarding the permissibility of having functions for which approval/clearance is not required on an instrument intended to be used with approved/ cleared in vitro diagnostic assays. This guidance is meant to communicate FDA’s policy regarding molecular diagnostic instruments with combined functions. This guidance applies to molecular diagnostic instruments that are medical devices used with assays that measure or characterize nucleic acid analytes, PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 67175 human or microbial, and that combine both approved/cleared and nonapproved/non-cleared functions in a single instrument. This guidance applies to the instrument itself (hardware) as well as to any firmware or software intended to operate on or to control the instrument. This guidance also addresses software that is distributed as a stand alone device for use with an approved/cleared molecular diagnostic assay. The guidance does not apply to instruments approved/cleared for use with assays that are intended to screen donors of blood and blood components, human cells, tissues, and cellular and tissue-based products, for communicable diseases. The document also does not apply to instruments approved/cleared for blood grouping. We encourage manufacturers wishing to market such instruments with combined functionality to contact the appropriate office in the Center for Biologics Evaluation and Research (CBER). The recommendations in this guidance do not apply to assays and reagents. They are also not intended to change FDA’s position regarding the marketing of Research Use Only and Investigational Use Only assays for clinical use. The draft guidance was announced in the Federal Register of April 9, 2013 (78 FR 21128), and the comment period closed on July 8, 2013. Several comments were received during the comment period. We took the suggestions into consideration in revising and finalizing this 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 Agency’s current thinking on molecular diagnostic instruments with combined functions. 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 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. Guidance documents are also available at https://www.regulations.gov or from E:\FR\FM\12NON1.SGM 12NON1 67176 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Molecular Diagnostic Instruments With Combined Functions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1763 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 803 have been approved under OMB control number 0910–0437; and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. Dated: November 5, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–26694 Filed 11–10–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES TKELLEY on DSK3SPTVN1PROD with NOTICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget SUMMARY: VerDate Sep<11>2014 17:55 Nov 10, 2014 Jkt 235001 (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 79, June 12, 2014 on page 33764 and allowed 60days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301– 435–0065, or Email your request, including your address to: glynnsa@ nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: HIV Study in Blood Donors From Five Chinese Regions, 0925–0596 Reinstatement With Change, National Heart, Lung and Blood Institute (NHLBI) Need and Use of Information Collection: This Study is a reinstatement with change of OMB Number: 0925– 0596 expiration date, January 31, 2012. To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study–III (REDS–III). The major objectives of the study will be to evaluate the proportion of blood PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 donors in China who test positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV–1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status. The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad crosssection of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, the study objectives have direct relevance for HIV control in the US and globally. Recent years have seen an increase in blood donations from repeat donors in most Chinese regions. This increase permits longer-term follow-up and testing of repeat donors which allow for calculation of new HIV infection rates and residual risks. The HIV data, for both recently and remotely acquired infections, from the proposed study will complement existing data on HIV risks obtained from general and high risk populations to provide comprehensive HIV surveillance data for China. This study will also monitor genetic characteristics of recently acquired infections through genotyping and drug resistance testing, thus serving a US and global public health imperative to monitor the genotypes of HIV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Genotyping and host response information are scientifically important not only to China, but to the US and other nations since they provide a broader global understanding of how to most effectively manage and potentially prevent HIV, for example through vaccine development. Efforts to develop vaccines funded by the National Institutes of Health and other US-based E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67175-67176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26694]



[[Page 67175]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0258]


Combined Functionality for Molecular Diagnostic Instruments; 
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 ``Molecular Diagnostic 
Instruments with Combined Functions.'' This guidance document provides 
industry and Agency staff with FDA's current thinking on regulation of 
molecular diagnostic instruments that combine in a single instrument 
both approved/cleared device functions and device functions for which 
approval/clearance is not required, and on the type of information that 
FDA recommends that applicants include in a submission for a molecular 
diagnostic instrument that measures or characterizes nucleic acid 
analytes and has combined functions.

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: 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 
``Molecular Diagnostic Instruments With Combined Functions'' 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 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.
    Submit electronic comments on the guidance to https://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: Andrew Grove, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198; 
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

    This guidance document provides industry and Agency staff with 
FDA's current thinking on regulation of molecular diagnostic 
instruments that combine in a single instrument both approved/cleared 
device functions and device functions for which approval/clearance is 
not required, and on the type of information that FDA recommends that 
applicants include in a submission for a molecular diagnostic 
instrument that measures or characterizes nucleic acid analytes and has 
combined functions. Molecular diagnostic instruments, for example, 
real-time thermocyclers, are critical components of certain in vitro 
diagnostic devices. They are often used to perform multiple unrelated 
assays, such as those that detect methicillin resistant Staphylococcus 
aureus, hepatitis C virus, and genetic markers of cystic fibrosis. 
These types of instruments cannot generally be approved/cleared alone, 
i.e., without an accompanying assay, because their safety and 
effectiveness cannot be evaluated without reference to the assays that 
they run and their defined performance parameters. However, the same 
instruments may also be used for additional purposes that do not 
require FDA approval or clearance, such as for basic scientific 
research. In the past, FDA has provided informal advice in response to 
individual inquiries regarding the permissibility of having functions 
for which approval/clearance is not required on an instrument intended 
to be used with approved/cleared in vitro diagnostic assays. This 
guidance is meant to communicate FDA's policy regarding molecular 
diagnostic instruments with combined functions.
    This guidance applies to molecular diagnostic instruments that are 
medical devices used with assays that measure or characterize nucleic 
acid analytes, human or microbial, and that combine both approved/
cleared and non-approved/non-cleared functions in a single instrument. 
This guidance applies to the instrument itself (hardware) as well as to 
any firmware or software intended to operate on or to control the 
instrument. This guidance also addresses software that is distributed 
as a stand alone device for use with an approved/cleared molecular 
diagnostic assay.
    The guidance does not apply to instruments approved/cleared for use 
with assays that are intended to screen donors of blood and blood 
components, human cells, tissues, and cellular and tissue-based 
products, for communicable diseases. The document also does not apply 
to instruments approved/cleared for blood grouping. We encourage 
manufacturers wishing to market such instruments with combined 
functionality to contact the appropriate office in the Center for 
Biologics Evaluation and Research (CBER).
    The recommendations in this guidance do not apply to assays and 
reagents. They are also not intended to change FDA's position regarding 
the marketing of Research Use Only and Investigational Use Only assays 
for clinical use.
    The draft guidance was announced in the Federal Register of April 
9, 2013 (78 FR 21128), and the comment period closed on July 8, 2013. 
Several comments were received during the comment period. We took the 
suggestions into consideration in revising and finalizing this 
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 
Agency's current thinking on molecular diagnostic instruments with 
combined functions. 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 
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. Guidance 
documents are also available at https://www.regulations.gov or from

[[Page 67176]]

CBER at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Molecular Diagnostic Instruments With 
Combined Functions'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1763 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 803 have been approved under OMB control 
number 0910-0437; and the collections of information in 21 CFR part 801 
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

V. Comments

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

    Dated: November 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26694 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.