82 FR 60024 - Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 241 (December 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 241 (December 18, 2017)
| Page Range | 60024-60025 | |
| FR Document | 2017-27132 |
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)] [Notices] [Pages 60024-60025] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27132] ----------------------------------------------------------------------- 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[Docket No. FDA-2017-D-6765] Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared for use based on performance characteristics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 This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: 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 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.thefederalregister.org/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 ``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. FOR FURTHER INFORMATION CONTACT: 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. [[Page 60025]] SUPPLEMENTARY INFORMATION: I. Background In 2003, FDA issued updated guidance on the ``replacement reagent and instrument family policy'' for in vitro diagnostic (IVD) devices. The 2003 guidance described a mechanism for manufacturers to follow when applying 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. Through the approach described in the 2003 guidance, manufacturers established sufficient control to maintain the level of safety and effectiveness demonstrated in the cleared device for these types of modified devices, when evaluated against predefined acceptance criteria using a proper validation protocol, without submission of a premarket notification (510(k)). FDA believes this policy is important for public health as it promotes more timely availability of a wider array of clinical laboratory tests for patient benefit. To ensure that its full benefits are realized, FDA is providing additional clarity to help manufacturers and FDA better apply the concepts in the guidance. This draft guidance, when finalized, is intended to update and provide clarity on the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff. It incorporates concepts and recommendations from FDA's guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' issued on October 25, 2017 (82 FR 49375). 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 Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic 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 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 guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16045 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 and guidances. 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 820 are approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910- 0120; the collections of information in 21 CFR parts 801 and 809 are approved under OMB control number 0910-0485; the collections of information in the guidance document ``Administrative Procedures for CLIA [Clinical Laboratory Improvement Amendments of 1988] Categorization'' are approved under OMB control number 0910-0607; and the collections of information for requests for feedback on medical device submissions in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' are approved under OMB control number 0910-0756. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27132 Filed 12-15-17; 8:45 am] BILLING CODE 4164-01-P
![60024 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
been approved under OMB control Electronic Submissions information you claim to be confidential
number 0910–0073; the collections of Submit electronic comments in the with a heading or cover note that states
information in 21 CFR part 312 have following way: ‘‘THIS DOCUMENT CONTAINS
been approved under OMB control • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
number 0910–0014; and the collections https://www.regulations.gov. Follow the Agency will review this copy, including
of information in 21 CFR part 314 have instructions for submitting comments. the claimed confidential information, in
been approved under OMB control Comments submitted electronically, its consideration of comments. The
number 0910–0001. The collections of including attachments, to https:// second copy, which will have the
information in the guidance document www.regulations.gov will be posted to claimed confidential information
entitled ‘‘Requests for Feedback on the docket unchanged. Because your redacted/blacked out, will be available
Medical Device Submissions: The Pre- comment will be made public, you are for public viewing and posted on
Submission Program and Meetings with solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration Staff’’ comment does not include any both copies to the Dockets Management
have been approved under OMB control confidential information that you or a Staff. If you do not wish your name and
number 0910–0756. third party may not wish to be posted, contact information to be made publicly
Dated: December 12, 2017. such as medical information, your or available, you can provide this
Leslie Kux, anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Associate Commissioner for Policy.
as a manufacturing process. Please note must identify this information as
[FR Doc. 2017–27155 Filed 12–15–17; 8:45 am]
that if you include your name, contact ‘‘confidential.’’ Any information marked
BILLING CODE 4164–01–P as ‘‘confidential’’ will not be disclosed
information, or other information that
identifies you in the body of your except in accordance with 21 CFR 10.20
comments, that information will be and other applicable disclosure law. For
DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. more information about FDA’s posting
HUMAN SERVICES
• If you want to submit a comment of comments to public dockets, see 80
Food and Drug Administration with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
[Docket No. FDA–2017–D–6765] fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a
written/paper submission and in the 23389.pdf.
Replacement Reagent and Instrument Docket: For access to the docket to
Family Policy for In Vitro Diagnostic manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). read background documents or the
Devices; Draft Guidance for Industry electronic and written/paper comments
and Food and Drug Administration Written/Paper Submissions received, go to https://
Staff; Availability www.regulations.gov and insert the
Submit written/paper submissions as
AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the
HHS. • Mail/Hand delivery/Courier (for heading of this document, into the
ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
announcing the availability of the draft • For written/paper comments You may submit comments on any
guidance entitled ‘‘Replacement Reagent submitted to the Dockets Management guidance at any time (see 21 CFR
and Instrument Family Policy for In Staff, FDA will post your comment, as 10.115(g)(5)).
Vitro Diagnostic Devices.’’ FDA is well as any attachments, except for An electronic copy of the guidance
issuing this draft guidance document to information submitted, marked and document is available for download
update and clarify the policy for a identified, as confidential, if submitted from the internet. See the
manufacturer’s application of an assay as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION section for
that was previously cleared for use Instructions: All submissions received information on electronic access to the
based on performance characteristics must include the Docket No. FDA– guidance. Submit written requests for a
with a specified instrument, to an 2017–D–6765 for ‘‘Replacement Reagent single hard copy of the draft guidance
additional instrument that was and Instrument Family Policy for In document entitled ‘‘Replacement
previously cleared or that is a member Vitro Diagnostic Devices; Draft Reagent and Instrument Family Policy
of an instrument family from which Guidance for Industry and Food and for In Vitro Diagnostic Devices’’ to the
another member has been previously Drug Administration Staff.’’ Received Office of the Center Director, Guidance
cleared. When finalized, this document comments will be placed in the docket and Policy Development, Center for
will supersede ‘‘Replacement Reagent and, except for those submitted as Devices and Radiological Health, Food
and Instrument Family Policy,’’ issued ‘‘Confidential Submissions,’’ publicly and Drug Administration, 10903 New
on December 11, 2003. This draft viewable at https://www.regulations.gov Hampshire Ave., Bldg. 66, Rm. 5431,
guidance is not final nor is it in effect or at the Dockets Management Staff Silver Spring, MD 20993–0002. Send
at this time. between 9 a.m. and 4 p.m., Monday one self-addressed adhesive label to
DATES: Submit either electronic or through Friday. assist that office in processing your
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance • Confidential Submissions—To request.
by March 19, 2018 to ensure that the submit a comment with confidential FOR FURTHER INFORMATION CONTACT: Avis
Agency considers your comment on this information that you do not wish to be Danishefsky, Center for Devices and
draft guidance before it begins work on made publicly available, submit your Radiological Health, Food and Drug
the final version of the guidance. comments only as a written/paper Administration, 10903 New Hampshire
ADDRESSES: You may submit comments submission. You should submit two Ave., Bldg. 66, Rm. 5620, Silver Spring,
on any guidances at any time as follows: copies total. One copy will include the MD 20993–0002, 301–796–6142.
VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/82_FR_60265/page/1.svg)
![Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60025
SUPPLEMENTARY INFORMATION: Center for Devices and Radiological amended, notice is hereby given of the
Health guidance documents is available following meeting.
I. Background The meeting will be closed to the
at https://www.fda.gov/MedicalDevices/
In 2003, FDA issued updated DeviceRegulationandGuidance/ public in accordance with the
guidance on the ‘‘replacement reagent GuidanceDocuments/default.htm. This provisions set forth in sections
and instrument family policy’’ for in guidance document is also available at 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
vitro diagnostic (IVD) devices. The 2003 https://www.regulations.gov. Persons as amended. The grant applications and
guidance described a mechanism for unable to download an electronic copy the discussions could disclose
manufacturers to follow when applying of ‘‘Replacement Reagent and confidential trade secrets or commercial
an assay that was previously cleared for Instrument Family Policy for In Vitro property such as patentable material,
use based on performance Diagnostic Devices’’ may send an email and personal information concerning
characteristics with a specified request to CDRH-Guidance@fda.hhs.gov individuals associated with the grant
instrument, to an additional instrument to receive an electronic copy of the applications, the disclosure of which
that was previously cleared or that is a document. Please use the document would constitute a clearly unwarranted
member of an instrument family from number 16045 to identify the guidance invasion of personal privacy.
which another member has been you are requesting. Name of Committee: National Institute of
previously cleared. Through the Allergy and Infectious Diseases Special
approach described in the 2003 IV. Paperwork Reduction Act of 1995
Emphasis Panel; NIAID Clinical Trial
guidance, manufacturers established This draft guidance refers to Planning Grant (R34) and Implementation
sufficient control to maintain the level previously approved collections of
Cooperative Agreement (U01).
of safety and effectiveness demonstrated Date: January 16, 2018.
information found in FDA regulations Time: 10:00 a.m. to 12:00 p.m.
in the cleared device for these types of and guidances. These collections of
modified devices, when evaluated Agenda: To review and evaluate grant
information are subject to review by the applications.
against predefined acceptance criteria Office of Management and Budget Place: National Institutes of Health, 5601
using a proper validation protocol, (OMB) under the Paperwork Reduction Fishers Lane, Rockville, MD 20892
without submission of a premarket Act of 1995 (44 U.S.C. 3501–3520). The (Telephone Conference Call).
notification (510(k)). collections of information in 21 CFR Contact Person: Maryam Feili-Hariri,
FDA believes this policy is important Ph.D., Scientific Review Officer, Scientific
part 820 are approved under OMB Review Program, Division of Extramural
for public health as it promotes more
control number 0910–0073; the Activities, National Institutes of Health/
timely availability of a wider array of
collections of information in 21 CFR NIAID, 5601 Fishers Lane, Rockville, MD
clinical laboratory tests for patient
part 807, subpart E are approved under 20852, 240–669–5026, haririmf@
benefit. To ensure that its full benefits
OMB control number 0910–0120; the niaid.nih.gov.
are realized, FDA is providing
collections of information in 21 CFR (Catalogue of Federal Domestic Assistance
additional clarity to help manufacturers
parts 801 and 809 are approved under Program Nos. 93.855, Allergy, Immunology,
and FDA better apply the concepts in and Transplantation Research; 93.856,
OMB control number 0910–0485; the
the guidance. Microbiology and Infectious Diseases
This draft guidance, when finalized, collections of information in the
guidance document ‘‘Administrative Research, National Institutes of Health, HHS)
is intended to update and provide
Procedures for CLIA [Clinical Dated: December 12, 2017.
clarity on the Replacement Reagent and
Instrument Family Policy for Laboratory Improvement Amendments Natasha M. Copeland,
manufacturers of IVD devices and FDA of 1988] Categorization’’ are approved Program Analyst, Office of Federal Advisory
staff. It incorporates concepts and under OMB control number 0910–0607; Committee Policy.
recommendations from FDA’s guidance and the collections of information for [FR Doc. 2017–27128 Filed 12–15–17; 8:45 am]
entitled ‘‘Deciding When to Submit a requests for feedback on medical device BILLING CODE 4140–01–P
510(k) for a Change to an Existing submissions in the guidance document
Device,’’ issued on October 25, 2017 (82 ‘‘Requests for Feedback on Medical
FR 49375). Device Submissions: The Pre- DEPARTMENT OF HEALTH AND
Submission Program and Meetings with HUMAN SERVICES
II. Significance of Guidance Food and Drug Administration Staff’’
This draft guidance is being issued are approved under OMB control National Institutes of Health
consistent with FDA’s good guidance number 0910–0756.
Eunice Kennedy Shriver National
practices regulation (21 CFR 10.115). Dated: December 12, 2017. Institute of Child Health & Human
The draft guidance, when finalized, will Leslie Kux, Development; Notice of Closed
represent the current thinking of FDA Associate Commissioner for Policy. Meetings
on the Replacement Reagent and [FR Doc. 2017–27132 Filed 12–15–17; 8:45 am]
Instrument Family Policy for In Vitro Pursuant to section 10(d) of the
BILLING CODE 4164–01–P
Diagnostic Devices. It does not establish Federal Advisory Committee Act, as
any rights for any person and is not amended, notice is hereby given of the
binding on FDA or the public. You can DEPARTMENT OF HEALTH AND following meetings.
use an alternative approach if it satisfies The meetings will be closed to the
HUMAN SERVICES
the requirements of the applicable public in accordance with the
statutes and regulations. This guidance National Institutes of Health provisions set forth in sections
daltland on DSKBBV9HB2PROD with NOTICES
is not subject to Executive Order 12866. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Institute of Allergy and as amended. The grant applications and
III. Electronic Access Infectious Diseases; Notice of Closed the discussions could disclose
Persons interested in obtaining a copy Meeting confidential trade secrets or commercial
of the draft guidance may do so by property such as patentable material,
downloading an electronic copy from Pursuant to section 10(d) of the and personal information concerning
the internet. A search capability for all Federal Advisory Committee Act, as individuals associated with the grant
VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/82_FR_60265/page/2.svg)
Document Created: 2017-12-15 23:54:54
Document Modified: 2017-12-15 23:54:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on 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. | |
| Contact | 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. | |
| FR Citation | 82 FR 60024 |
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