82 FR 60024 - Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared for use based on performance characteristics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 This draft guidance is not final nor is it in effect at this time.

[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]


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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Diagnostic Devices; Draft Guidance for Industry and Food and Drug 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.

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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the availability of the draft guidance entitled ``Replacement Reagent 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issuing this draft guidance document to update and clarify the policy 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 This draft guidance is not final nor is it in effect 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